Jobs That Crossed My Desk Through March 24, 2013 Complimentary Service of Audreysnetwork.com

March 24, 2013

If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Note that recently I’ve begun to receive many listings via Linked In and in such cases, I’ve listed company website if not person who sent listing to me. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG meetings to become member but application in free. See details at www.bio2devicegroup.org.

******************************************************** Apply on company website Regional CRA Sterling Life Sciences - California (San Francisco Bay Area) Job Description See below for a job description / partial list of responsibilities. If you wish to apply, simply click the ‘Apply’ button and fill out the form or email your resume to: resumes@sterlinglifesciences.com (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 1) Conduct site visits (initiation, monitoring, termination) 2) Adhere to FDA, ICH-GCP regulations and local regulations 3) Ensure completion and collection of SAEs 4) Instruct the site staff in their roles and responsibilities in conducting clinical trials 5) Evaluate and report site performance and protocol compliance 6) Perform data verification of source documents, CRFs collection, product accountability and supply tracking 7) Assist with data validation and resolution of queries 8) Ensure compliance with SOPs More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions

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(if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Clinical-Research-Affairs-Anywhere-Biotechnology-Jobs-Careers-90598 TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://goo.gl/uTzVl We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). Remember: to apply for this position, click the ‘Apply’ button on Linkedin and complete the form. If you have trouble uploading your resume, email your resume to: resumes@sterlinglifesciences.com Additional Information Posted:March 22, 2013 Type:Full-time Experience:Mid-Senior level Functions:Project Management, Research, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:9998112109059881210

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Job ID:5196052 ___________________________________________ Senior Regulatory Affairs Specialist Sterling Life Sciences- California (San Francisco Bay Area) Job Description See below for a job description / partial list of responsibilities. If you wish to apply, simply click the ‘Apply’ button and fill out the form or email your resume to: resumes@sterlinglifesciences.com (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 1) Work with various project teams and provide regulatory support to assigned teams as needed 2) Prepare and maintain international regulatory submissions and other pre-market registrations to acquire appropriate commercial distribution clearances in an expeditious manner 3) Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with regulatory management as needed 4) Control and maintain regulatory records 5) Represent regulatory affairs on various design and development teams by attending team meetings and providing the required plans, procedures and regulatory decisions 6) Confer with other departments about the regulatory requirements of new product designs and changes to existing designs 7) Review and approve new documents and product changes for compliance and to determine if a new premarket application is required 8) Assist engineering in maintenance of design history files and related records on an as needed basis and where regulatory responsibilities permit 9) Review technical publications, articles and abstracts to stay abreast of regulatory and technical developments in the industry More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Regulatory-Affairs-California-Biotechnology-Jobs-Careers-89907

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TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://goo.gl/uTzVl We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). Remember: to apply for this position, click the ‘Apply’ button on Linkedin and complete the form. If you have trouble uploading your resume, email your resume to: resumes@sterlinglifesciences.com Additional Information Posted:March 22, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science, Project Management, Quality Assurance Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11181189907 Job ID:5196042 ______________________________________ Product Sales Manager ( Business Development ) Sterling Life Sciences - California (San Francisco Bay Area) Job Description See below for a job description / partial list of responsibilities. If you wish to apply, simply click the ‘Apply’ button and fill out the form or email your resume to: resumes@sterlinglifesciences.com (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 1) Manage staff from hiring to training to firing represents an important job of product sales managers 2) Maintain and increase sales of the company's products

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3) Ensure that all sales representative activities are in accordance with the guidelines of the company's code of conduct 4) Observe the performance of medical representatives in the field on a regular basis 5) Co-ordinate proper company resources to ensure efficient and stable product sales results 6) Establish and control budgets for product sales promotion and trade show expenses 7) Develop specific plans to ensure revenue growth in all company's products More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Sales-Marketing-California-Biotechnology-Jobs-Careers-88629 TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://goo.gl/uTzVl We respect your privacy. Your resume will *never* be shared without your permission.

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If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). Remember: to apply for this position, click the ‘Apply’ button on Linkedin and complete the form. If you have trouble uploading your resume, email your resume to: resumes@sterlinglifesciences.com Additional Information Posted:March 22, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales, Business Development, Marketing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11177188629 Job ID:5196031 ****************************************************** Apply on company website Manager, Global Scientific Communications, Top Pharma - California Cornerstone Search Group- Los Angeles (Greater Los Angeles Area) Job Description Our client, a highly successful California pharmaceutical company focused on unmet medical needs, is seeking an individual with publication management experience, an advanced degree (PhD is a plus), and an energetic, positive personality to join their growing Global Publications team. Attractive Features of this Position / Company: • This is a highly successful and growing Pharmaceutical company with marketed drugs in multiple therapeutic areas. • The head of the Publications team is highly personable and has very good experience. • This company that offers the best of both worlds - a profitable and growing global multi-billion pharma company that is also not too rigid or bureaucratic and has a relatively flat organizational structure where you will have a lot of responsibility and opportunities to make a real impact. • You will be responsible for leading cross-functional publication planning teams as well as driving publication execution on a global basis for one of this company’s core therapeutic areas. Core Responsibilities: • Oversee the development of strategic publication plans for one of the company’s major therapeutic areas. • Ensure globalization of your publication plans. • Represent the publications’ perspective on cross-functional teams in your therapeutic area, and guide the team’s decisions regarding scientific communications. • Interface with Medical Affairs and Clinical Development leadership in order to ensure successful integration of publications into their overall plans. • Identify and implement ways to improve the Publication’s team processes.

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• Develop and report metrics with the goal of improving the Publication process. Title: Publication Manager * Please note that we are also helping our client hire another individual for this growing team at the “Publication Specialist” level, which is a level that requires less experience than the Manager position. They would even consider a PhD who has been published but hasn’t before worked in this type of function before. Location: Southern California. Relocation: An attractive relocation package is available. Qualifications Desired: • MS at a minimum. Ph.D. / MD a plus. • Ideally 3+ years of publication management experience. Please note that they also have another position open at the “Publication Specialist” level for those with 0-2 years of experience. • Strategic mindset • Demonstrated track record of driving projects to successful fruition on time and on budget. • Demonstrated track record of building partnerships • Energetic and positive personality. Cornerstone Search Group’s Privacy Policy: Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted to us as confidential information. This information will not to be shared with any parties outside of Cornerstone Search Group without your prior permission. Contact: Corey S. Ackerman, JD | Senior Partner www.linkedin.com/in/coreyackerman USA: 973.656.0220 ext. 716 | CH: 41 61 508 7010 cackerman@cornerstonesg.com CORNERSTONE SEARCH GROUP, LLC (www.cornerstonesg.com) Life Sciences Executive Search 6 Campus Drive | Parsippany, NJ 07054 p 973.656.0220 x 716 | f 973.656.0228 Email: cackerman@cornerstonesg.com Desired Skills & Experience • MS at a minimum. Ph.D. / MD a plus. • Ideally 3+ years of publication management experience. Please note that they also have another position open at the “Publication Specialist” level for those with 0-2 years of experience. • Strategic mindset • Demonstrated track record of driving projects to successful fruition on time and on budget. • Demonstrated track record of building partnerships • Energetic and positive personality. Company Description Cornerstone Search Group partners with US and Global Pharmaceutical, Biotech and other Life Sciences companies to identify and recruit professionals for their senior staff through executive management level needs. Our services include: Retained Search, Contingent Search

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(permanent and contract positions), and Strategic Advisory Services (e.g. org structure, recruitment strategies, compensation / benefit guidance). Additional Information Posted:March 22, 2013 Type:Full-time Experience:Associate Functions:Research, Other, Science Industries:Biotechnology, Pharmaceuticals Employer Job ID:caBH2070li Job ID:5041438 ******************************************************* Apply on company website Biobank Manager Quest Diagnostics- San Juan Capistrano, CA (Orange County, California Area) Job Description Quest Diagnostics (NYSE: DGX) is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. We currently have an opportunity available for a Biobank Manager in our Clinical Development department in San Juan Capistrano, CA. The Clinical Development Biobank Manager (CDBM) oversees the functioning of the Nichols Institute's clinical specimen collection and inventory and is responsible for managing Clinical Development Coordinators (CDCs). This person assists the Clinical Development and the Clinical Franchise teams in developing strategies for clinical specimen collection. The CDBM reviews sample management projects for accuracy and effectiveness, verifies clinical specimens in the inventory were ethically obtained and maintains the appropriate documentation. Responsibilities:

Provide oversight, leadership and technical direction to (CDCs); ensure that sample management projects are aligned with Clinical Franchise needs, in compliance with Good Clinical Practices, Good Laboratory Practices, Quality, Business and Industry standards

Continuously refine and improve Nichols Institute’s BioBanking capabilities. Ensure that all department policies and processes are compliant with associated regulatory guidelines

Continuously review and improve the Clinical Specimen Inventory System (CSIS). Assist CDCs who use the CSIS software system to import and export data for statistical analysis. Assist CDCs who obtain, track and electronically store data using the LIS computer system

Prepares schedules, resolves problems, establishes and monitors deadlines to ensure timely completion of work. Participates in Clinical Development team meetings and provides periodic updates on sample management projects

Establishes and maintains strategic metrics and monitors performance Is proficient using document control software for standard operating procedures.

Communicates with supervisor regarding new and revised standard operating procedures

Participates in routine lab maintenance, lab biosafety, ISO and QSR implementation, and supports the requirements of successful Safety, Quality and Regulatory audits

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Maintains a working knowledge of regulations and scientific literature Desired Skills & Experience

Masters degree in a scientific discipline such as molecular biology, pathology, cell biology or related scientific discipline; PhD preferred

Minimum of 7 years experience in Biobanking with an established track record of overseeing specimen processing and laboratory logistics, interfacing with numerous laboratory procedures as well as strong administrative skills with management experience

Experience using inventory tracking systems and interfacing with laboratory information systems

A solid understanding in specimen collection, processing, shipping and storage Must have strong interpersonal, computer and technical skills Critical reasoning/problem solving skills to identify and resolve complex problems

Company Description Quest Diagnostics Incorporated (NYSE: DGX) is the leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers physicians the broadest test menu (3,000+ tests), is a pioneer in developing innovative new tests, is the leader in cancer diagnostics, provides anatomic pathology (AP) services, & interpretive consultation through its medical & scientific staff of about 900 M.D.s & Ph.D.s. The company has about 43,000 employees, serves approximately ½ of all physicians & hospitals in the U.S., & reported 2009 revenues of $7.5 billion. Quest Diagnostics offers the most extensive clinical testing network in the U.S., with laboratories in most major metropolitan areas, & in Mexico, the UK & India. The company also operates four esoteric laboratories, 40 outpatient AP laboratories, & 160 smaller, rapid-response laboratories. Patients may have specimens collected in any of the company’s approximately 2,000 patient service centers. On a typical workday, testing is performed for about 550,000 patients. With its MedPlus subsidiary, Quest Diagnostics empowers healthcare organizations & clinicians with state-of-the-art connectivity solutions. The company is the leading provider of pre-employment drugs-of-abuse screening for employers & risk assessment services for the life insurance industry. It is the world’s 2nd largest provider of clinical trials testing for new pharmaceuticals. Additional Information Posted:March 22, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science, Health Care Provider Industries:Hospital & Health Care, Health, Wellness and Fitness Job ID:5194704 ****************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5196625&trk=eml-anet_dig-b_premjb-ttl-cn&ut=2vCwhVfpT4W5E1 Clinical Trial Manager PharmAscent- San Francisco Bay Area Job Description Excellent opportunity for a Clinical Trial Manager opportunity in the San Francisco Bay Area! (PERM AND CONTRACT OPENINGS) PHARMA CLINICAL TRIAL MANAGER SAN FRANCISCO BAY AREA

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Job Description: · The Clinical Trial Manager will provide direction and leadership to one or more clinical operations team · Clinical Trial Manager will work under the supervision and guidance of the Director, Clinical Operations to ensure execution and completion of the following clinical drug development activities · Has had experience as a key clinical operations leader on significant Phase II or Phase III programs. · Provides significant contributions and leadership as part of the clinical protocol development team. · Independently creates and/or oversees the design of study related documents including but not limited to: clinical protocols, case report forms, case report form completion guidelines, study manuals and project tools, monitoring plans, tracking tools, informed consent forms. · Support of departmental functions for preparation and/or attendance at departmental meetings, clinical operations training and developmental activities as required and directed. · Leads study management team meetings and teleconferences with study vendors. · Manages study-specific CROs and vendors and contract CRAs as appropriate. · Performs independent monitoring of sites as required by needs of project. · Attends scientific meetings as a representative of Co’s clinical operations team. · Coordinates efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages. · Adds critical insight regarding evaluation and selection of CRO’s, contractors and other outside vendors, including oversight of the RFP process. · Provides study leadership and effectively collaborates with other departments within CR&D to meet study timelines and corporate goals. · Proactively identifies and communicates study-related issues and facilitates discussion of potential solutions that can be implemented by the team. · Coordinates clinical research SOP updates as appropriate and provides training to the team. · Works with Financial Operations Coordinator on vendor and study site budget tracking and compliance. · Uses well-developed problem-solving skills to address needs of program and provides guidance to other lower level personnel. Desired Skills & Experience Knowledge/Skill Requirements: Clinical Trial Manager should have BA/BS in science-related field. Clinical Trial Manager should have 8-12+ years work experience Demonstrated thorough understanding of FDA regulations and GCP. ***APPLY TODAY OR REFER A FRIEND! We offer a terrific referral bonus! Madelene Marinas/ Sr. Clinical Recruiter mmarinas(at)pharmascent.com 925-627-4916 Company Description ***PharmAscent specializes in contract staffing, contract to hire, direct hire search and small project consulting services for the FDA-regulated industries. Our team has over 40 years of combined experience in identifying top notch professionals for direct hire and contract staffing needs. We understand that “people” are the key to a successful organization. Our goal is to deliver innovative people through proven best practices and effective resource optimization. Feel free to visit us at... www.pharmascent.com Additional Information Posted:March 22, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science Industries:Biotechnology Compensation:competitive Referral Bonus:$500!! Job ID:5196625 ****************************************************** Contact me today regarding a great opportunity as a Study Clinician in the La Jolla, CA area. krista.leach@kellyscientific.com Now Hiring: Study Clinician (Non-MD) in San Diego, CA

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Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have a contract opportunity for a Clinicianfor our client in Jolla, CA. The Non-MD/Study Clinician integrates scientific drug development knowledge to ensure excellence in development and translation of clinical research plans into efficiently delivered studies. •The Non-MD/Study Clinician is responsible for working collaboratively with the clinical leader, physician and members of the development team to establish the Clinical Development Plans for one or more compounds from lead development in Discovery to Phase I-II clinical trials and the BioSimilars compounds through registration •The Non-MD/Study Clinician is responsible for developing methodologies to support proof of pharmacology, proof of mechanism, proof of concept and biosimilarity studies •The Non-MD/Study Clinician provides input to the operational strategy and feasibility of clinical research studies, in partnership with development operations •The Non-MD/Study Clinician actively participates in defining the key components of the clinical protocols •Responsible for the formulation of clinical development plans, trial design, protocols, amendments and conduct data review, analysis and interpretation •Responsible for clinical research studies (methodology studies, biomarker studies, proof of mechanism studies, proof of concept studies, biosimilarity, medical device studies etc) from trial design (development of outline/core elements) through clinical review, oversight and reporting •Responsible for final recommendations to clinical development plans for one or more compounds, including the review of pre-clinical package after seeking appropriate input, review and endorsement from key stakeholders for go no-go development decision criteria •In collaboration with the clinical leader, prepare strategy decisions, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings •Lead efforts to author clinical sections of regulatory documents including the Investigator Brochure, Annual Reports, IND sections •Consistent with Safety Review Plans, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the safety risk lead (as delegated by the clinical lead). The specific components of safety data review are detailed in the Safety Data Review Guide – for Clinicians and SAF09 SOP •Lead efforts with discovery, safety sciences, statistics, PK/PD, marketing, regulatory, outcomes research, development operations and other members of the extended project

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team(s) at the study or compound level •Acts as a liaison with internal groups including internal governance, commercial and external experts and potential regulators •Responds and contributes to novel study designs •Maintains a high degree of aw... http://bull.hn/l/1326V/4 ******************************************************* If you or someone you know is qualified and interested please contact me privately at dave@alpinesearch.net Dave Murphy The Alpine GroupBiotech Manager of Market Research & Analytics - SF Bay area A client of mine in the Genetic Testing market has asked me to find someone to build and lead their Market Analytics function. This is their first dedicated market research / analytics position, reporting to the VP of Marketing, in a company that has doubled in size in the past three years (they launched their first test one year ago with great success). The role is a mix of primary and secondary research, competitive intelligence, forecasting and database management, and will have one direct report. Qualifications: -3+ years of market research and analytics experience in the Life Science industry (Biotech, Diagnostics, or Medical Device) -Primary and secondary research experience, competitive intelligence, and dashboard metric design -Bachelors degree or better is required; an MBA is strongly preferred ****************************************************** Apply on company website Product Manager/Sr Product Manager Consumables Illumina- San Diego (Greater San Diego Area) Job Description The Product Manager/Sr Product Manager, MiSeq Consumables will be responsible for managing the marketing activities necessary for the continued development and commercial support of sequencing consumables. Job duties include but are not limited to: • Drive the development of marketing requirements, priorities, and plans for continued evolution, refinement, and extension of cluster generation and sequencing chemistry kits for the Illumina Sequencing Portfolio. • Work closely with Corporate Marketing to coordinate and successfully generate all portfolio collateral, including system profiles, training material, promotional items and activities. • Develop and maintain financial, unit forecasting, and pricing models • Partner with R&D, Operations, Sales and Customer Solutions organizations in a cross-functional environment to ensure successful deployment of new consumables products. • Coordinate successful relationships with key customers to ensure successful adoption and evolution of the sequencing portfolio. • Train and support the Field organization to ensure accomplishment of the milestones in the annual revenue plan. Desired Skills & Experience Education and Experience:

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• Bachelor’s Degree; PhD and/or MBA desirable but not required • 2 to 6 years of relevant experience (i.e. internships and/or work experience in academia, genome centers, biotechnology and/or medical device industries, or related field) • Demonstrated experience in launching products in the life sciences field is required • Experience defining product requirements and working with R&D to ensure development of products based on customer and business requirements. • Must have experience in customer interaction in either a Sales, Technical Support, or Marketing function • Experience working in cross-functional teams covering various internal organizations • An excellent technical understanding of molecular biology and biochemical techniques is desirable • Must have strong presentation and communication skills • Must have experience creating financial models and setting pricing policies • Willing to travel domestically and internationally up to 30% Equal Opportunity Employer Company Description At Illumina, our goal is to apply innovative technologies and revolutionary assays to the analysis of genetic variation and function, making studies possible that were not even imaginable just a few years ago. These studies will help make the realization of personalized medicine possible. With such rapid advances in technology taking place, it is mission critical to have solutions that are not only innovative, but flexible, scalable, and complete with industry-leading support and service. As a global company that places high value on collaborative interactions, rapid delivery of solutions, and prioritizing the needs of its customers, we strive to meet this challenge. Illumina’s innovative, array-based solutions for DNA, RNA, and protein analysis serve as tools for disease research, drug development, and the development of molecular tests in the clinic. Additional Information Posted:March 21, 2013 Type:Full-time Experience:Mid-Senior level Functions:Product Management Industries:Biotechnology Job ID:5181536 ****************************************************** Posted by Megan Kilgannon, Sr. Pharmaceutical Recruiter at The Judge Group Email mkk@judge.com Looking for a new job? -QC Analyst - Molecular Assays- Looking to hire in the next 2-3 weeks! San Diego, CA Molecular Biology QC (Quality Control) in San Diego, CA The Judge Group is currently recruiting a QC Analyst for a dynamic client in San Diego- PCR, molecular assays. This is a contract position and you must be able to work as a W2 contractor directly for Judge. For immediate consideration please email your resume to mkk@judge.com Job duties include but are not limited to: - Day to day management of a production process, management of a process flow that occurs across several departments. - Preparation, and use of next-generation sequencing samples. - Perform routine and non-routine analytical biochemical and molecular biology assays to support release, characterization and stability testing of raw materials, production intermediates and final goods.

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- Careful documentation of laboratory procedures. - Analysis of data generated by functional assays. - Participate in developing and validating testing methodology, revising and updating Standard Operating Procedures - Review data obtained for compliance to specifications and report abnormalities **1st shift role Sun - Thurs (6am-3pm) Background needed: BS/MS in Biology/Molecular Biology biochemistry, chemistry or related discipline - Two to Five years of industry experience with Functional analysis QC of molecular-biology-based assays preferred, other QC, R&D or manufacturing experience will be considered. - Ability to understand and follow work instructions and perform molecular biology assays with little guidance. - Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint) - GMP experience a plus Skills - Good hands in the lab & preferably with multichannel pipetting / molecular bio bench work and/or assays that are sensitive such as qPCR. - Precision and attention to detail -Hard working self-starter & accustomed to a fast-paced environment - Self starter, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential. - Flexible: able to respond quickly to shifting priorities and meet deadlines - Basic molecular biology laboratory skills such as pipetting, PCR, gel extraction, etc. required. - Experience with DNA or RNA sample preparation, sequencing, qPCR, robotics, or related technology is a plus. - Experience and familiarity with instrumentation is a plus - Analysis of large data sets is also a plus http://bull.hn/l/12Y1J/1 **************************************************** Posted by Matthew Hatle, Director of Recruiting at Bio-Pharma Searches, Inc If qualified and interested, please contact me at matthewdhatle@gmail.com, 760-452-8686, or via LinkedIn. http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=225065627&gid=61852&trk=eml-anet_dig-b_jb-ttl-cn&ut=1Wwx-NFRnUU5E1 NEEDED: Director of Regulatory Affairs (South SF Bay) NEEDED: Director of Regulatory Affairs (South SF Bay) Searching for a Director of Regulatory Affairs for an international mid-sized biologics pharmaceutical company located in the south SF Bay area. REQUIRED: 5 years of biologics RA experience, INDs, NDAs, CTAs, BLAs and MAAs experience, CMC experience, and experience working with US in international regulatory agencies. ******************************************************** https://jobs.smartbrief.com/action/listing?listingid=376D8178-AF77-4ADE-860C-E682DEA973A1&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Sales Area Manager/Sales Rep of Neurovascular Intervention Products

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Asahi Intecc USA, Inc. Job Description This position will be responsible for the sales of Neurovascular intervention products. Responsibility includes -Sales activity -Product training to phycicians and lab staff - Promotion and tradeshow support - Clinical case observation and market feedback - Marketing activity support ******************************************************************* Apply on company website Resource Manager - can also be known as Staffer, Location Manager or Staff Coordinator IMS Consulting Group- Downtown San Francisco (San Francisco Bay Area) Job Description The Resource Manager (RM) role within IMS Consulting Group is a critical one as the RM is the primary contact point for a Principal when a project is sold. The RM works in partnership with the senior leadership of IMS Consulting Group to ensure that a cross functional team is aligned to meet the client needs. In parallel, the RM works closely with each member of the project team to ensure that project roles meet development goals and provide the on-the-job training necessary to build a career in consulting. This is a position that has two sets of internal clients – the delivery team (analysts through senior consultants) and the senior team (engagement managers and above) Often, this unique insight into our business and our core internal stakeholders results in opportunities for the RM to lead internal organizational projects. The environment is dynamic and ever-changing, moving at the pace of our clients’ needs. The global RM team consists of former consultants who understand the sense of urgency that is synonymous with management consulting. As such, while this is a fast-paced role, there is also a degree of flexibility and a goal of maintaining work/life balance for this position. This role reports to the Director of Resource Management, based on the East Coast. Operating as a US Resource Manager within the global resourcing team, to ensure the effective deployment of US West-Coast based consulting delivery team onto projects, business development opportunities and internal IMS Consulting Group initiatives. Through resourcing decisions, support career development and retention of US based Consulting delivery team members. We are looking for a unique individual who can:

Identify and resource West Coast consulting team members to client projects, business development opportunities, thought leadership and IMS Consulting Group internal initiatives

Collaborate effectively with global resource management team to deploy consulting delivery team members in a manner that optimizes overall productivity while meeting individual development objectives

Engage with the principals and other senior leaders to understand, plan for and ultimately meet the resourcing demands of their pipeline

Enable and support development goals of West Coast analyst consulting delivery team through resource management decisions

Monitor and communicate current and planned delivery capacity Maintain resource management data integrity in the PSA system that supports resource

and project management decisions

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Identify resourcing capability gaps in the analyst to senior consultant team as an input to hiring and to provide guidance/insight into Learning & Development plans the development of training plans

Work on / lead internal projects with team members from the client facing, HR, Finance, Operations and other internal functions

Desired Skills & Experience Bachelors degree or equivalent Prior consulting delivery experience in a professional services environment Proven problem-solving skills with attention to detail Strong written and verbal communication skills Ability to build strong business relationships and influence with key stakeholders at all

levels within the business Excellent team-based interpersonal skills with ability to work independently Ability to demonstrate determination, diplomacy and resilience Ability to rapidly assimilate multiple types of information from a variety of sources for

effective decision making Proficient in Microsoft Office applications Knowledge of life science consulting is a plus

This position is full time and allows for a flexible working schedule. It is based in our IMSCG San Francisco office in the financial district. Company Description IMS Consulting Group is the world’s leading, specialized advisor on critical business issues in the life sciences, and is the management consulting arm of IMS Health, a leading provider of information, services and technology for the healthcare industry in 100+ countries around the world. Our IMS Consulting Group teams offer end-to-end management consulting in key issues areas that include: business unit, therapy area and brand strategy, portfolio strategy, launch strategy, pricing & market access studies and commercial model design and optimization. IMS Consulting Group is an Equal Opportunity Employer.We cultivate a diverse corporate culture across the 100+ countries where we operate, celebrating and rewarding teamwork and inclusiveness. By embracing our differences, we create innovative solutions that are good for IMS, our clients, and the advancement of healthcare everywhere. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Mid-Senior level Functions:Management Industries:Management Consulting Job ID:4683292 ******************************************************* Apply on company website Biologics Procurement Manager ( Purchasing / Sourcing ) Sterling Life Sciences- California (San Francisco Bay Area) Job Description See below for a job description / partial list of responsibilities. If you wish to apply, simply click the ‘Apply’ button and fill out the form or email your resume to: resumes@sterlinglifesciences.com (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES)

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============================================== 1) Develop the company's supply-chain to ensure adequate supply of various biological tissue types needed to meet market demand 2) Manage business relationships with existing tissue collection sites plus expanding the network of suppliers to meet production requirements and enable introduction of new products 3) Develop the company's diseased tissue program and manage efforts with internal staff (Sales, Marketing and Operations) to ensure continuous supply of tissue meeting customer requirements More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Purchasing-Procurement-California-Biotechnology-Jobs-Careers-89903 TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at:

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http://goo.gl/uTzVl We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). Remember: to apply for this position, click the ‘Apply’ button on Linkedin and complete the form. If you have trouble uploading your resume, email your resume to: resumes@sterlinglifesciences.com Additional Information Posted:March 19, 2013 Type:Full-time Experience:Mid-Senior level Functions:Purchasing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11177189903 Job ID:5153332 ********************************************************* http://www.linkedin.com/jobs?viewJob=&jobId=5168442&trk=eml-anet_dig-b_premjb-ttl-cn&ut=2A44PpRnDxSBE1 Specialty Pharmacy Sales Representative FSN Specialty Pharmacy- San Francisco Bay Area Job Description

Develop and submit detailed sales and marketing plans every 6 months for assigned territory/territories outlining market opportunities, specific strategies for capturing new business, number and type of planned prospect and customer contacts, and schedule of community and industry events, as well as other key areas as determined collaboratively by the CSR and Director of Sales and Marketing, including specific time- and performance-related goals and milestones.

Assist in identifying and initiating contact with provider network, IPAs, and or any third party payers within territory to support the access to said networks or payers for the purposes of contracting and or LOA.

Meet or exceed all personal performance objectives determined by Director of Sales and Marketing in regular performance review (every 6 months).

Demonstrate a commitment to ongoing professional growth and performance improvement.

Represent company professionally and positively at all times. Participate actively in biweekly sales team meetings via teleconference. Develop and submit weekly schedule projections outlining all planned sales and

marketing activities Desired Skills & Experience The ideal candidate should possess in-depth knowledge of the medical industry, Specialty Pharmacy, Home Health, Managed Care, Biologics, and other blood derivative products. The specialty pharmacy representative – neurology/immunology will be responsible for managing the business within a specific geographical territory.

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This person will execute a sales marketing strategy, create and implement a territory business plan to maximize referral opportunities with neurology, and immunology, and hematology practices whose patients require SQ and IV immune globulin therapy. Minimum of three years experience in outside sales, specialty pharmacy, medical sales is preferred. Company Description FSN Specialty Pharmacy is a CHAP accredited specialty infusion pharmacy. Founded in 1994, we are licensed in 40+ states and service clients nationwide. Individual client attention is our utmost goal while using our experience to help control costs to third party payers. We value innovative thinkers who are open to new opportunities and derive satisfaction from knowing that their efforts are making a difference in someone’s life. FSN specializes in providing the following therapies: Home IVIG and SQ IG, Hemophilia. Additional Information Posted:March 20, 2013 Type:Full-time Experience:Associate Functions:Sales Industries:Hospital & Health Care Job ID:5168442 Veteran Commitment

FSN Specialty Pharmacy commits to hiring returning veterans. ******************************************************* Posted by Jim Deavours, President, F-O-R-T-U-N-E Personnel Consultants of Atlanta Contact Jim at jimd@fpcccareers.com Senior Principal Engineer / Biopharmaceuticals – Aseptic Fill / Finish - California Industry leader in the Pharmaceutical and Biopharmaceutical Industry seeks Senior Principal Engineer to lead and support projects for Aseptic Fill / Finish and Lyophilization at an expanding manufacturing site. As the Subject Matter Expert, the Senior Principal Engineer will be responsible for the design, selection, start-up and commissioning of Aseptic Fill / Finish and Lyophilization lines and equipment. He / she will also be responsible for equipment improvement and problem resolutions regarding Fill / Finish and Freeze Drying as well as managing shut down, equipment replacement and start up operations. The ideal candidate will possess a B.S. in Engineering, experience managing capital projects for Aseptic Fill / Finish in GMP / Pharmaceutical manufacturing and demonstrated expertise in supporting related equipment and processes. The Senior Principal Engineer will be a self-starter with the ability to take charge and thrive in a fast-paced environment. The company provides a success oriented work environment with highly competitive compensation and benefits. ***************************************************** Posted by Jennifer Capelli, Pharmaceutical Recruiter Send resumes to pharmacontractjobs@gmail.com Mechanical Design Engineer (Medical Device) position in Irwindale,CA (2 year contract) ....

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SUMMARY: Under little or no supervision, designs and documents effective and efficient tools, fixtures, machines for the manufacture of Company products and assists in the design of company products in the feasibility stage by performing the duties below. This individual should have the ability to be a main technical contributor on feasibility-to-production programs. This is position is for a fast paced incubator group. Person must demonstrate that they are highly motivated with high energy and drive. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. • Provides engineering and design services to the research and development engineering group. • Implements complex design concepts and ideas into working drawings. Must be experienced in AutoCAD and Solidworks. • Studies specifications, engineering blueprints, tool orders, and shop data and confers with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost. • Develops concepts, designs and details for machines, tools and fixtures INDEPENDENTLY. • Provides all design changes for existing products. Ensures proper documentation of changes. • Applies algebraic and geometric formulas and standard tool engineering data to develop tool configuration. • Selects standard items such as bushings and tool bits to incorporate into tool design. • Inspects and tests tools and fixtures after fabrication to ensure that the meet specifications. • Understands the process in which tool design is being applied. • Interfaces with outside suppliers as needed. • Draws preliminary sketches and prepares layout and detail drawings. • Detail testing and troubleshooting experience a plus. Will perform testing to understand design features. • Modifies tool designs according to trial or production service data to improve tool life or performance. • Provides advice and guidance to less seasoned engineering designers. • Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company. • Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes. • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Familiarity with AutoCAD and Solidworks is a must. Should have experience with machine shop tools and strong design porrtfolio. Experience with plastic extrusion, injection molding, etc. is a plus. Should be able to lead a team and demonstrate prior technical lead experience. Should demonstrate prior work with either small component systems or medical devices. The individual should be solution focused, have high energy to be able to drive to solutions. EDUCATION and/or EXPERIENCE: BS in Mechanical Engineering or equivalent with 5-10 years of related experience and/or training; MS preffered. Significant experience in the design and fabrication of tools will be considered. Send resumes to pharmacontractjobs@gmail.com

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*************************************************** Posted by Isabel Brito, Atlantic Management Resources Send resumes ibrito@amrjobs.com We need specialty sales reps in San Jose, CA. We need specialty sales reps in San Jose, CA. Our client is a small, specialty pharma company that's rapidly expanding. They're looking for individuals with 2+ years pharma sales experience. Previous B2B experience is a plus, but not necessary. *************************************************** To view job description and other current positions please visit http://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Margaret@JGBBioPharma.com or Nicole@JGBBioPharma.. No Work Visa sponsorship is available for this job. Associate Director/Director, Clinical Quality Assurance (Full time position, San Francisco Bay area) Description: This position will play an essential role in directing the company’s Clinical QA program. Focus includes conducting internal and external Clinical audits to ensure the clinical trials are conducted in accordance with GCP regulations and ICH guidelines. The incumbent will be responsible for ensuring clinical studies are performed in compliance with FibroGen procedures and protocols. The incumbent is also responsible for developing internal and external auditing plans and activities, training of staff as needed and in the development/maintenance of GCP related quality systems including, CAPA and Deviation management. Specific Duties • Develops quality system policies and SOPs for Clinical QA in compliance with applicable regulatory requirements and best industry practice. • Ensures clinical trials are performed in accordance with applicable study protocols, and are in compliance with Good Clinical Practice and ICH guidelines. • Conducts Good Clinical Practice compliance audits of a sampling of Investigator sites, Clinical Research Organization (CRO) facilities and vendors, in accordance with Audit Plans. • Conducts internal audits to ensure compliance with Department Guidelines and Procedures, and Good Clinical Practice and ICH Guidelines. • Provides expert QA advice to Clinical Operations based on analysis and interpretation of updates to GCP regulations to assure best Clinical/QA practices. • Supports the administration of the company’s training program, and conducts Good Clinical Practice training to internal Clinical Departments and externally, if applicable. • Conducts or manages targeted training of investigators/site staff. • Reports significant quality deficiencies to QA management. • Manages and assists Clinical Working Groups in the implementation of Corrective Action Plans. • Coordinate responses to regulatory agency inspections. • 25 - 35% travel required. • Perform data integrity audits. • Perform for cause GCP audits • Manage the clinical CAPA and Deviation systems • Job Requirements: • Must have a BS/BA or MS/MA degree in a related discipline. • A minimum 7 years of related experience; or MS/MA degree in related discipline and minimum five 5 years of related clinical QA experience

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• Current and strong working knowledge interpretation/implementation of Code of Federal Regulations and ICH Guidelines governing clinical trials and recent initiatives. • Excellent verbal and written communication skills, ability to work well in teams or independently and able to prioritize work, manage multiple projects while maintaining quality and advocate for compliance. • Position requires a highly diplomatic and tactful individual with exceptional critical reasoning skills who is detail oriented • Experience working with clinical sites • Experience in developing SOPs in for quality assurance and compliance. • Experience with clinical trials at all phases of development. • Experience with creating quality systems in a small company environment • Uses expertise or unique knowledge and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways • Ability to deal with ambiguity, creative and pragmatic approach to problem solving. Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com ********************************************************* Posted by Sarah Lefford-Cieslik, Senior Recruiting Consultant at Life Technologies (thru ProUnlimited) Recruiting for a "Regulatory Manager" to strategically support U.S. and International In-Vitro Diagnostic Medical Device regulatory activities in Carlsbad or San Fran, CA! Life Technologies is seeking an experienced Regulatory Manager to strategically support U.S. and International In-Vitro Diagnostic Medical Device regulatory activities at its Carlsbad, California or South San Francisco facilities (Ion Torrent). The incumbent will work in the Global Regulatory Affairs department to establish and execute the regulatory strategy and submissions related to Ion Torrent products including Next Generation Sequencing technologies. In addition, incumbent will maintain appropriate systems to ensure Regulatory Compliance consistent with state, federal and international laws. Candidates with extensive knowledge and experience in the IVD industry are encouraged to apply as the positions title and responsibilities may expand in the future. Must have a minimum of 5 years of IVD Regulatory Affairs experience. This experience must include either 510(k) or PMA Submissions. Experience with CE-IVD Technical Files (IVDD) is a plus. Must be well versed in the aspects of design control, cGMP/Quality Systems, and import/export requirements. Experience with RUO products. Contact me for more info: c-Sarah.Cieslik@lifetech.com And visit our website to view the JD and apply online! Careers at Life Technologieslifetechnologies.com At Life Technologies, we believe in the power of science to transform life and the power of people to make it happen. If you a€™re ready to take charge of your impact in the world, you can do it here. We a€™re a diverse group... ****************************************************** Posted by Erin Martin, VWR Career Center, Member of the VWR Career Center Variety of Biotech, Lab, Science, and Pharma openings (CA, PA, MN, TX, NE, and more) With 160 years of industry experience, VWR offers a well-established distribution network that reaches thousands of specialized labs and facilities spanning the globe. VWR has over 8,000 associates around the world working to streamline the way researchers across North America, Europe, and Asia stock and maintain their labs. If you’re interested in joining our team, check out some of our highlighted career opportunities:

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• Glass Washer (Foster City, CA): http://bit.ly/XDomiB • Coverage Specialist (Pennsylvania- multiple remote locations): http://bit.ly/10IxO3T • Site Services Coordinator (Novato, CA): http://bit.ly/YsNAwu • Business Development Director (Any major US metro area): http://bit.ly/ZoaDLe • Production Technology Sales Representative (San Francisco, CA): http://bit.ly/13TXX3Z • Production Technology Sales Representative (Minneapolis, MN): http://bit.ly/ZMGCXt • Coordinator (Deer Park, TX): http://bit.ly/ZoaXJY • Technician (Lincoln, NE): http://bit.ly/XJX2ja • VMI Technician (Oceanside CA): http://bit.ly/ZFHGJ6 Connect with me on LinkedIn, and follow VWR Careers on Facebook (https://www.facebook.com/VWRcareers) and Twitter (https://twitter.com/VWRCareers). ***************************************************** Started by Jon Hauptman, President, The Hauptman Group Healthcare Search Consultants Biotech Clinical Sales Specialist Positions - Inland Empire and San Diego! APPLY DIRECT to www.thehauptmangroup.com Small and aggressive biotech sales organization is looking for a proven and highly decorated pharmaceutical/biotech sales representative! The sales representative will call on various specialties (Nephrology, Neurology, Rheumatology, Pulmonology, Neuro-muscular) promoting injectable line for various genetic disorders. Product is an injectable. MUST HAVE QUALIFICATIONS: 4 year degree 3-5 years Pharmaceutical / Biotech experience (preferably in LCDs) Strong track record of Exceeding Sales Targets Strong Clinical Acumen Must currently be in pharmaceuticals/biotech Experience in Buy & Bill preferred. Injectable experience a plus! Must have documentation supporting results Strong clinical acumen Total Compensation: $110k - $140k Outstanding Benefits:Salary, Bonus (uncapped), Medical Dental, Stock, Etc. ********************************************************

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Vinod Sharma (973) 967-3583 Vinod_Sharma@artechinfo.com My name is Vinod and I'm a recruiter at Artech, a global staffing and IT consulting company. We are constantly on the look out for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you. Below is a summary of the position. Job Title: Clinical Scientist III - C Location: Santa Clara - AV, CA 95054 Duration: 12 months contract Job Description: Description This position is NonExempt. Hours over 40 will be paid at Time and a Half.• The Clinical Research Scientist will be involved primarily with medical writing. Significant medical writing expertise and learning ability required to maintain pace in the market (MS Office: Word, Excel, PowerPoint). • Exceptional communication skills both oral and written. • Excellent problem solving ability. • Effective project and time management skills. • Excellent planning and organizational skills to demonstrate initiative. • Ability to demonstrate good business judgment. • Clinical trial experience preferred Key Competencies: • Communicating Effectively • Planning and Organization Education: • Terminal degree (MD, PharmD,or PhD) preferred Please ask each candidate for a list of selected publications which they have either authored or co-authored? This will be a needed piece to the hiring process. Please attach the publications when submitting them into the tool. Hiring Manager is looking for the followings: • Clinical trial experience and knowledge required • Medical device experience preferred. • Experience/knowledge in interventional cardiology preferred. If you believe you're qualified for this position and are currently in the job market or interested in making a change, please give me a call as soon as possible at (973) 967-3583. You may respond to me via email but please be sure to include your direct phone number so I can reach out to you quickly. In considering candidates for our various positions, time is of the essence and we are committed to responding to our clients promptly. ********************************************************* Apply on company website Director, State Government Affairs (REMOTE - West Coast) Onyx Pharmaceuticals- REMOTE - West Coast (San Francisco Bay Area) Job Description The Director of State Government Affairs will provide expertise in government affairs by translating state political and policy issues into strategic and actionable plans. Primary responsibilities include leading local and state government affairs strategy in South San Francisco and across the top priority states including California and Texas while monitoring 15 western states to optimize and champion market access to facilitate market entry in new and emerging markets. Additionally, evaluating and assessing access to cancer treatments for Onyx therapies through State Exchanges in the western states are a key function of this role. In this role the Director will advance sound public health and legislative policies in areas of

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importance to Onyx at the local and state level with a particular emphasis on policies to address oncology policies specific to multiple myeloma, liver cancer, advanced renal cell cancers, colorectal cancer and GIST. The Director will oversee and manage professional lobbyists in multiple states. They will develop trusted relationships with elected officials and their staff, utilize expertise and knowledge internally and externally to develop and craft policy positions and collaborate with third-party stakeholders that impact policy decisions and drive change. Essential/Primary Duties, Functions and Responsibilities:

Responsible for state government affairs/government relations and engagement across the western region of the country with attention to local government and stakeholders in South San Francisco, CA on key policy issues while working with a contract lobbyist to monitoring healthcare legislation in the remaining states.

Responsible for understanding and communicating how state exchanges will provide access to cancer treatments through communication with state Insurance Commissioners and State Health Exchanges while working with state legislature and contract lobbyist to elevate awareness on the issue and identify appropriate state level contacts to assess the issue.

Responsible for working with state Medicaid programs to ensure access for Onyx products.

Responsible for identifying state legislative, executive branch, and regulatory proposals and policies impacting the marketing and selling of Onyx Pharmaceuticals products, analyzing the impact of those proposals on ONYX, and developing policy recommendations to address those proposals.

The State Government Affairs Director develops and implements appropriate strategies and tactics to achieve the desired outcomes through a combination of direct lobbying and legislative coalition-building.

Major program responsibilities include negotiating rebates with state Medicaid agencies, the legislative and budgetary facets of Medicaid, and state pharmaceutical assistance initiatives for the elderly.

State Government Affairs Director responsibilities includes working cross-functionally with ONYX’s policy staff and business operations to assure effective “pull through” for products in the region. Through political skills and policy knowledge, the State Government Affairs Director is able to make decisions on legislative/regulatory matters.

State Government Affairs Director has an established broad range of contacts, an in-depth knowledge of processes, policy expertise and extensive issue management skills.

The State Government Affairs Director, SGA must have an understanding of issues effecting not only the sale and marketing of prescription medicines, but also of issues facing a large, national business operating in the United States. Those issues include, but are not limited to, tort and related civil justice reforms, tax, worker’s compensation and environmental policies, and economic development.

The State Government Affairs Director identifies and facilitates introduction of ONYX Executives to targeted state legislative and executive branch leadership and prepares ONYX Executive briefings for meetings with leadership which advance ONYX strategic objectives. As well coordinating quarterly government speaker series onsite at Onyx Pharmaceuticals in South San Francisco, CA

The State Government Affairs Director must demonstrate an intuitive sense of issues affecting the ONYX corporate image and exercises the necessary judgment to protect and advance the image in all oral and written communications and interactions with state government officials and business community thought leaders.

The State Government Affairs Director will successfully integrate him/herself into policy and business organizations that can advance ONYX legislative and policy objectives and actively works to educate, advocate for, and protect ONYX strategic interests.

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Responsibilities also include protecting both patients’ and the company’s interests by working through and within state government policy, laws and regulations, to ensure the greatest possible access for Onyx products to key patient populations.

Assess outside counsel and lobbying needs within each state and manage these resources appropriately.

Responsible for devising strategic policy initiatives designed to ease or open access to patients for Onyx products. This includes evaluating the need for outside counsel and lobbying services.

Desired Skills & Experience Work Experience:

Experience with understanding bio pharmaceutical industry trends with a strong knowledge of, and experience with, US State Government Agencies

Experience in translating political activity and policy trends into commercial impact Success with political engagement to support market access and reimbursement Experience with the legislative processes Proven track record of successful advocacy and winning legislative battles and current

relationships with elected officials, agency heads and policymakers. Management of Staff: None Functional/Technical Knowledge & Skills: Proficient use of technology including MS Office Software Package and Internet resources is expected. Customer & Industry Knowledge: Relationships with state and local government officials in Sacramento and South San Francisco, CA, and some priority states are desirable. Additional relationships with CA industry associations and Key stakeholders are also highly desirable. Education/Training:

Bachelor's degree in political science, business or life sciences preferred. Minimum of 10 years of experience in related experience in State Government Affairs,

ideally in oncology both new market and established market. Prior experience with federal/state affairs is preferred. A diverse background to include

but not be limited to: Field Management, Corporate Account, Marketing, Reimbursement, or Managed Care experiences are a plus.

Other Requirements: Competencies

Excellent interpersonal, analytical, and communication skills, both written and oral are necessary.

Strong organizational, planning, conceptual, and strategic thinking skills Must be able to work successfully within a team/partnership environment and as an

individual contributor, with a high level of professionalism Demonstrated ability to lead and provide guidance to others Ability to build and maintain deep relationships with both internal and external

stakeholders, executives and thought leaders Candidate must be an adaptive, innovative, strategic thinker, self-starter and

demonstrated team player with strong leadership abilities actively demonstrated in prior positions

Company Description Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals

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Inc., is developing and marketing Nexavar® (sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a selective proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, an alpha-folate receptor targeted inhibitor of thymidylate synthase, and ONX 0912, an oral proteasome inhibitor, are currently in Phase 1 testing. For more information about Onyx, visit the company's website at www.onyx-pharm.com. Additional Information Posted:March 19, 2013 Type:Full-time Experience:Director Functions:Public Relations Industries:Pharmaceuticals Job ID:5149081 ***************************************************** Posted by Ron Bucher, Customer Support and Services Executive Apply on Cepheid company website Opportunity in Sunnyvale for world class instrument repair center technician with potential management career path. Exceptional written and oral communication skills required. Service Center Leadjobs-cepheid.icims.com Your application choices are:Cepheid administers its personnel policies and conducts its employment practices in a manner that treats each employee and applicant for employment on the basis of merit and experience, without... _________________________________________________ http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=224446179&gid=3412079&trk=eml-anet_dig-b_jb-ttl-cn&ut=3B18F5N8I6RlE1 RMA and Field Service Dispatcher opportunity in Sunnyvale Medical device and QAD experience are preferred but not required. Senior Service Coordinatorjobs-cepheid.icims.com *************************************************************** Posted by Cynthia@GrantProSearch.com http://www.linkedin.com/jobs?viewJob=&jobId=5160245&trk=eml-anet_dig-b_premjb-ttl-cn&ut=10Tbf1eubZR5E1 Specialty Pharmaceutical Sales Representative GrantProSearch- San Jose, CA (San Francisco Bay Area) Job Description This specialty pharmaceutical client company develops and manufactures innovative products in niche specialty area of GI. They have for more than 20yrs. where they licensed, developed and marketed innovative products to treat GI problems. Client company is looking for a high caliber sales professional who is passionate about selling with a positive attitude and solid work ethic. The sales representative will call on specialty physicians in San Jose including Palo Alto to Salinas. Candidate salary will be based on experience. Desired Skills & Experience BA/BS required.

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2-5 years extremely successful pharmaceutical sales experience candidate. With solid B to B expereince prior to Pharma.

Candidate must have documented sales success including consistent record of performance.

Looking for competitive team player. Candidate must be DRIVEN. Must have STABLE employment background- NO JOB HOPPING! Must be great team player and communicator. Must be able to show great business acumen and be accountable. Must show ability to be clinically astute.

Company Description GrantProSearch assists healthcare companies; pharmaceuticals, bio-technical, medical diagnostics, medical device, hospitals and clinics as well as partnering with start up organizations for their professional staffing needs. Each search is treated individually with the knowledge and expertise of your market segment. GrantProsearch team members devote the requisite time in identifying qualified candidates who meet the specific criteria of each client. GrantProSearch's objective is to ensure the candidate’s interest and excitement about your opportunity. We understand our client’s need to select from a narrow list of professional candidates quickly so that they can reduce their hiring costs. We are a certified member of the Women's Business Enterprise National Council. And we serve as a board member on First Interview Company, a network of over one hundred and twenty healthcare industry recruitment firms. Additional Information Posted:March 20, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales Industries:Pharmaceuticals Compensation:salary uncapped commission and stock Referral Bonus:stock upon hire Job ID:5160245 ****************************************************** Apply on company website Consumable Engineer- Cepheid Job Description The Cepheid Engineering team is seeking a Consumables Engineer who will apply their experience with injection molded plastics to transform product requirements into sustainable, large-scale consumables production. The successful candidate must be able to use their knowledge of mechanical design, materials and mold processes to engineer custom solutions, improve current designs, interface with vendors, and enable large scale manufacturing of consumables for the medical device industry. They will use their experience in consumables manufacturing to transition designs from the Concept phase through Design and Development and into Production. They will actively sustain and support re-qualifications of existing parts used in Production following tooling repairs and refurbishments. This is a hands-on position involving detailed design, testing, prototype fabrication and Engineering support of Production; must be able to interface well with other engineers, scientists, vendors, and operations personnel. There are no direct reports to this position. Maintain and/or improve existing consumables parts production, with an emphasis on refining part specifications, improving manufacturability, and achieving cost reductions; Manage product lifecycles for multiple diverse consumables and ensure the timely introductions of new cartridge products. Use CAD modeling, prototyping, and hands-on lab testing to develop new designs to support and enhance consumable product line. Establish working relationships with vendors for parts/molds under Development. Coordinate with Purchasing for modification to parts in Production.

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Enforce high quality standards for all consumables products; Design, test, and validate new consumable designs in collaboration with diverse functional groups; Assist in failure investigations and root cause analyses as they relate to consumables parts performance; Coordinate Engineering testing, first article inspections, and qualifications for new tools and repairs to existing tools. Write verification and validation protocols and related reports to support the transfer of designs into Production. Actively participate in group meetings and be a technical point person in project teams. Create custom fixtures and procedures for test of consumables parts designs and tolerancing. Work with Manufacturing Engineering to create initial BOMs and updated models as required. BS in Mechanical Engineering or equivalent. Proven experience with large-scale injection molding (5-years minimum experience)Fundamentals of material properties, mold flow, and tooling design; Excellent verbal and written communication skills. Proficiency with SolidWorks. Must be proficient with standard Microsoft Office applications. Experience with inspection and measurement techniques; Experienced with creating drawings, BOMs, product specifications Requirements BS in Mechanical Engineering or equivalent. Proven experience with large-scale injection molding (5-years minimum experience)Fundamentals of material properties, mold flow, and tooling design Excellent verbal and written communication skills. Proficiency with SolidWorks. Must be proficient with standard Microsoft Office applications. Experience with inspection and measurement techniques Experienced with creating drawings, BOMs, product specifications ******************************************************** Contact Michael Miller BioSearch Recruiting (800) 977-2170 michael@biosearchrecruiting.com Associate Director of Global Labeling, Bay Area This position will be responsible for: 1. Providing regulatory guidance and oversight of global labeling activities for all company commercial products. 2. Providing regulatory guidance to development teams on the clinical design requirements to support labeling claims. 3. Managing Labeling Teams and labeling content worldwide. 4. Ensuring commercial product labeling is compliant with the worldwide regulations and the highest quality. 5. Support the Head of Global Labeling with the core labeling program and global labeling management. Other major responsibilities of the job. 1. Maintaining thorough knowledge of current rules and regulations governing labeling activities: • Develop, implement, and maintain internal policies and procedures for appropriate review, approval and finalization of global labeling. • Partner with Phramacoviligance, Clinical, Commercial, Medical Affairs, and other staff on related content of labeling. • Manage product labeling teams for new labeling and revisions to exisiting labeling. • Train relevant staff on labeling policies and procedures, “best practices” and FDA enforcement actions. • Provide recommendations to RA content manger regarding appropriate labeling text based on regulatory requirements and/or best practices. For example: 1. Agency’s layout and format requirements and regulatory precedent if guidelines are not available.

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2. Communicate new regulatory guidelines and the direct impact to labeling. 3. Minimize redundancy. 4. Compliance with Core Labeling reference document (e.g., CCDS). 5. Appropriate cross referencing. • Ensure annotation of labeling changes is complete and accurate. • Track labeling differences from the Core Labeling and local labeling including deviations and the related rationale. 2. Providing regulatory guidance to project teams on the requirements to support labeling claims: • Stay abreast of current regulatory requirements for labeling. 1. Work with cross-functional teams generating comments on draft guidances. 2. Determine the impact of new and revised guidances and ensuring that the new requirements are communicated across the functional teams and departments. 3. Present to internal regulatory staff and cross functional teams, labeling requirements and new labeling regulations and guidance. • Provide advice to teams on the FDA requirements and historical precedence supporting labeling claims. 3. Tracking and implementing of labeling. • Oversee tracking of on-going labeling projects. • Evaluate regulatory impact of labeling changes and review and approve change control requests. • Work with the Packaging and Supply Chain Groups to ensure current approved labeling is implemented. • Ensure international labeling is appropriately translated. 4. Labeling compliance: • Develop and prepare SOPs and desk procedures. • Provide training internally within Regulatory and cross functionally. • Perform detailed QC checks on labeling documents. • Ensure official current labeling electronic files are updated timely. • Support audits (internal or external) as needed. • Provide oversight and guidance to staff on labeling requirements, drug listing, establishment registrations, NDC, etc. EDUCATION Four year science degree, post graduate degree in science or law preferred. EXPERIENCE • Minimum 12+ years (Assoc. Director Level)/8-10 years (Sr. Manager Level) experience in the area of Life Sciences/Pharmaceutical Regulatory Affairs or related fields • 4+ years (Assoc Director Level)/ 3+ years (Sr Manager Level) direct experience with Labeling activities or equivalent experience • The Job Title will be assessed based on a candidates years of labeling expertise and proven experience. • Electronic Labeling (SPL) expertise • Proven knowledge and expertise in US labeling regulations/guidance • Experience with Global Labeling Management and CCDS (or equivalent) • EU and international labeling experience preferred • Ability to lead teams of varying management levels and cross functional representatives

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******************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5142977&trk=eml-anet_dig-b_premjb-ttl-cn&ut=31XvJcLIooPRE1 GCP Consultant Real Staffing Group- San Francisco Bay Area Job Description GCP Consultant A pharmaceutical company in the Palo Alto, CA area is looking for a GCP Consultant to join their team. This is an excellent opportunity to join a start-up with an exciting pipeline. GCP Consultant Overview: Provides critical direction, documentation, deliverables, assistance and support for all quality control compliance functions related to Good Clinical Practice (GCP) for clinical development activities. Ensure high level GCP compliance, documentation and adherence to company’s and external partners SOPs. The position requires a strong working knowledge of FDA regulations and guidance documents, International Conference on Harmonization guidelines and cGCP guidelines. Through proactive and comprehensive compliance initiatives directed by the Clinical Compliance Specialist, the company’s clinical development activities will be conducted at a very high level consistent with GCPs with robust documentation to provide confidence and assurance in all clinical data and results generated. The GCP Consultant will have the following responsibilities and roles:

Clinical SOPs, processes –development, revision, training and implementation of required SOPs

Oversight and accountability for compliance within the Clinical Department with internal SOPs, process, and regulatory requirements by:

Identifying process gaps Performing internal process assessments of clinical operations and or documentation Effectively documenting process improvements to demonstrate due diligence with

proactive compliance Identifying the critical components to achieving increased clinical compliance through a

risk-based approach Identify and development of specific tools, critical documents needed to track

compliance, and processes to enable proactive and systematic detection, analysis, remediation and prevention of compliance quality issues/risks

Identifying useful indicators for assessing compliance for ongoing performance of clinical vendors

Evaluating performance indicators tracked to ensure GCP compliance is maintained and to alert management of potential non-compliances

Effective strategies for tracking and recording changes to study documentation Participate in end of study documentation compliance reviews including data set review,

Tables, Listings and Findings, CSR, Trial Master File reconciliation Serve as Clinical interface with Topica’s Quality Assurance Group for all GCP internal

and external audits and CAPA. Some travel may be required to key clinical vendor sites and clinical research sites.

Desired Skills & Experience GCP ConsultantRequirements:

Minimum BS or equivalent and minimum 10 years clinical research experience in a pharmaceutical/biotech company working within clinical compliance, process improvement, and/or risk management

Proven ability to work independently, efficiently and effectively

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Effective communication and time management skills critical to achievement of QC goals;

Good working knowledge of clinical development software (IWRS, Rave, MS Office etc.); Familiarity with an outsourced clinical trial model; Ability to represent Topica effectively with CRO and key external vendors, and; Excellent documentation skills and systems design.

If you are interested in this position, please respond to this job positing ASAP. Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information Posted:March 18, 2013 Type:Contract Experience:Director Functions:Quality Assurance Industries:Pharmaceuticals Job ID:5142977 ********************************************************* Apply on company website

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Medical Information Manager Onyx Pharmaceuticals- South San Francisco (San Francisco Bay Area) Job Description The Medical information Manager is responsible for supporting Medical information initiatives for Onyx’s commercial products. Candidate will be a key member of the Medical Information Team based in South San Francisco, California. This position is responsible for assisting with the management of Medical Information activities. He/she will be reporting to the Director of Medical Information supporting the infrastructure, systems, databases and processes in support of the department objectives. The candidate will play a key role in reviewing technical documents, development of Medical Information materials, participation in review committees, Sales, Marketing, congress support and other medical information initiatives. The candidate will play a key role in maintaining the Medical Information Management System (IRMS) and will serve as an expert and knowledgeable resource for internal (Medical/Scientific Affairs, Safety, Marketing, and Sales) and external customers (Physician, Nurses, Pharmacists). Essential/Primary Duties, Functions and Responsibilities:

Serve as a medical reviewer for Onyx products (Legal, Regulatory and Medical Review Teams)

Assist with booth planning (content and materials) and support for expanding list of congresses, including international venues.

Assist with maintaining the Medical Information Database (IRMS). Assist with medical information letter creation, FAQ list, and technical documents. Collects and reports monthly Medical Information metrics Support the creation of departmental SOPs, guidelines and procedures necessary to

achieve organizational and compliance objectives. Works with the Project Coordinator on Onyx’s Library Enterprise (OLE) Support the Medical Information Team with the interactions, management and training

of Call Center and its staff; utilize effective project and people management skills to ensure achievement of department goals and objectives.

Interacts with Patient Support Services, Sales Training, MSLs, and Medical Communications.

Conduct business in accordance with ONYX Values. Other Duties as assigned.

Desired Skills & Experience Work Experience:

Oncology training/experience preferred Minimum of 3-5 year’s experience in biotech/pharmaceutical industry experience Knowledgeable of Medical Information Management Systems and Call Center experience

Customer & Industry Knowledge: Knowledge and understanding of relevant clinical and therapeutic issues Ability to create and present on scientific and clinical data

Education/Training: MPH, R.N., Pharm. D.

Other Requirements: Ability to work with multidisciplinary teams Excellent written, verbal and interpersonal communication skills Flexible, with positive attitude, strong ability to multi task, prioritize projects effectively

and communicate at all levels within the company Some travel required to represent company at medical conferences, presentations, and

other meetings Exceptional organization and project planning skills

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Strong interpersonal skills and the ability to relate and work with a wide range of people to achieve results

Competencies Medical Information Management Systems (IRMS) Knowledge of Medical Information Regulations

Company Description Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals Inc., is developing and marketing Nexavar® (sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a selective proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, an alpha-folate receptor targeted inhibitor of thymidylate synthase, and ONX 0912, an oral proteasome inhibitor, are currently in Phase 1 testing. For more information about Onyx, visit the company's website at www.onyx-pharm.com. Additional Information Posted:March 19, 2013 Type:Full-time Experience:Mid-Senior level Functions:Other Industries:Pharmaceuticals Job ID:5148469 ********************************************************

I would like to share more information with you. Please send me a copy of your resume to Giovanni@MullingsGroup.com

VP of Medical & Clinical Affairs – Bay Area – Hematology Biologics/Device

Ground breaking biologic company based in the Bay has discovered a proactive procedure for blood transfusion. We are looking for a VP of Medical & Clinical Affairs. Must have: • MD degree • Phase III clinical trial experience • Willing to travel 30% internationally • Hematology or oncology experience ***********************************************************

Jobs That Crossed My Desk Through March 17, 2013 *************************************************************

JGB BioPharma Consulting Inc. is working with Clients on the following Full time and Contract openings. Please go to our jobsite to see full job descriptions: www.jgbbiopharma.com/jobs

Feel free to send us your resume and we will contact you if we have anything appropriate. You can send your resume to Julie@jgbbiopharma.com

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FTE (Full time) positions (San Francisco Bay area): Medical Information Manager Director Drug Safety Bioinformatics Associate Director CMC Regulatory Manager CMC Regulatory Statistical Programmer (Multiple openings up to the Associate Director Level) Medical Writers/ Medical Writing Managers (Sr) GCP Quality Specialist GCP Quality Manager Quality Validation Specialist Quality Specialist (batch record review experience) Project Manager Diagnostics Regulatory Project Manager Director Asia CMO Quality (Senior) Clinical Program Manager (Sr) Clinical Trial Manager SCRA (Sr Clinical Research Associate) Texas: Clinical Research Associate (Medical Device experience) And these CONTRACT openings in the (San Francisco Bay area): (Note that most of our contract jobs are Contract to Full time hire) Clinical Trial Manager (Contract) Clinical Site Contracts / Budget Coordinator (Contract) GCP Quality Specialist (Contract) Quality Specialist (batch record review experience) Quality Validation Consultant Document Control Specialist CONTRACT POSITIONS ELSEWHERE

Southern California

Marketing Operations Specialist Interaction Designer

T Technical Writer U User Experience Designer T Technical Publications Writer S Senior Administrative Assistant S Specialty Receptionist T Technical Writer / Editor C Community Relations Coordinator

***********************************************************

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Clinical Pharmacist (Inpatient), Department Of Veterans Affairs, Palo Alto, CA

http://www.pharmacyweek.com/career/26771/Clinical-Pharmacist-Inpatient-California-Ca-Palo-Alto

**************************************************************

Apply Deb Denardis ddenardis@agiluxlabs.com. Come join an amazing company and supportive team as we all grow together.

Agilux Laboratories is looking for a Director of Business Development in California

Agilux labs is hiring a Director, Business Development-California area. Must be AGGRESSIVE Identify and develop new business opportunities in CA. Generate annual sales to meet or exceed the sales target for the territory.Conduct cold calls.Develop and maintain long term client relationships. Bachelor’s Degree, preferably in Science. Enthusiastic individual with strong customer service orientation.4 years emonstrated success in business development in CRO or pharmaceutical industry.

************************************************************** Apply on company website 1) Manage staff from hiring to training to firing represents an important job of product sales managers 2) Maintain and increase sales of the company's products Product Sales Manager ( Business Development ) Sterling Life Sciences - California (San Francisco Bay Area) Job Descriptio See below for a job description / partial list of responsibilities. If you wish to apply, simply click the ‘Apply’ button and fill out the form or email your resume to: resumes@sterlinglifesciences.com (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 3) Ensure that all sales representative activities are in accordance with the guidelines of the company's code of conduct 4) Observe the performance of medical representatives in the field on a regular basis 5) Co-ordinate proper company resources to ensure efficient and stable product sales results 6) Establish and control budgets for product sales promotion and trade show expenses 7) Develop specific plans to ensure revenue growth in all company's products More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our

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Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Sales-Marketing-California-Biotechnology-Jobs-Careers-88629 TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility

Company Description

Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://goo.gl/uTzVl

We respect your privacy. Your resume will *never* be shared without your permission.

If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter:

www.twitter.com/sterlinghoffman

Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time).

Remember: to apply for this position, click the ‘Apply’ button on Linkedin and complete the form. If you have trouble uploading your resume, email your resume to: resumes@sterlinglifesciences.com

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Additional Information Posted:March 11, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales, Business Development, Marketing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11169188629 Job ID:5073452 __________________________________________________________ Biologics Procurement Manager ( Purchasing / Sourcing ) Sterling Life Sciences - California (San Francisco Bay Area) Job Description See below for a job description / partial list of responsibilities. If you wish to apply, simply click the ‘Apply’ button and fill out the form or email your resume to: resumes@sterlinglifesciences.com (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 1) Develop the company's supply-chain to ensure adequate supply of various biological tissue types needed to meet market demand 2) Manage business relationships with existing tissue collection sites plus expanding the network of suppliers to meet production requirements and enable introduction of new products 3) Develop the company's diseased tissue program and manage efforts with internal staff (Sales, Marketing and Operations) to ensure continuous supply of tissue meeting customer requirements More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see

3/24/2013 39

another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Purchasing-Procurement-California-Biotechnology-Jobs-Careers-89903 TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://goo.gl/uTzVl We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). Remember: to apply for this position, click the ‘Apply’ button on Linkedin and complete the form. If you have trouble uploading your resume, email your resume to: resumes@sterlinglifesciences.com Additional Information Posted:March 11, 2013 Type:Full-time Experience:Mid-Senior level Functions:Purchasing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11169189903 Job ID:5073442

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******************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5084379&trk=eml-anet_dig-b_premjb-ttl-cn&ut=3GvNCl-nbzN5E1 Regulatory Affairs Publishing Specialist Pharmalink Consulting - San Francisco and San Diego (San Francisco Bay Area) Job Description Position Purpose: The Publisher is responsible for the publication of regulatory documents according to regulatory authority specifications and department standards for paper and electronic submissions to ensure delivery on all regulatory submission milestones and compliance with applicable regulatory obligations. Role Description: • Deliver project-specific paper and electronic submissions, including coordination and execution of publishing solutions that meet unique requirements of each submission and management of product delivery to regulatory agencies • Integrate data from various electronic or paper sources into either electronic or paper submissions using formats and styles essential for regulatory compliance •Collaborate effectively with team members to assemble, copy, quality check, and publish required documents. • Maintain a working knowledge of electronic and paper publishing systems and tools and how these are applied; fluently with multiple dossier formats and publishing requirements as required • Liaise with project team representatives to ensure paper and electronic submission requirements and timelines are mutually understood and in line with corporate standards and deadlines for dossier delivery to regional markets • Define, investigate, and implement regional and global process efficiencies for paper and electronic submission publishing, including the evaluation of current processes • Lead or participate on global/local teams to complete assignments and tasks within a specific task force/project associated with electronic and paper submissions • Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level • Work with the team leaders to effectively forecast and manage project-specific resources utilizing flexible resourcing, and global load sharing as normal business practice • Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimens, such that regulatory and internal compliance is preserved • Define and implement standards and regional process efficiencies for submission publishing and project learning sessions to meet these standards • Responsible for incoming Health Authority correspondence as well as archiving of final submissions and agency acknowledgement receipts into regulatory electronic archive repository • Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues • Provide Subject Matter Expertise for technical publishing tools and provide efficiency/enhancement proposals for the publishing tool suites •Create and maintain templates for regulatory submissions. Desired Skills & Experience 5+ years Regulatory experience; specifically in a Publishing function Bachelor's degree Company Description

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Pharmalink Consulting is the No 1 choice for sustainable outsourcing for all Regulatory Affairs requirements. We can resource any Regulatory Affairs project – regardless of size and timescale. From filing submissions to the more complex management of compliance issues and post-licensing activities, we are the experts in this field and can supply the market intelligence and consultants to match any Regulatory Affairs need – anywhere in the world. Unlike some other consultancies, Pharmalink specialises in Regulatory Affairs only. The business has become so specialised in the last 10-15 years, it requires dedicated teams of Consultants to meet the increasingly complex demands of local health authorities and keep abreast of all the changes that are constantly happening on a global and local market level. For additional information about the services offered by Pharmalink Consulting, please visit our website: www.pharmalinkconsulting.com Additional Information Posted:March 11, 2013 Type:Contract Experience:Associate Functions:Consulting Industries:Pharmaceuticals Job ID:5084379 ******************************************************* Connie Milburn connie.milburn@att.net Marketing Assistant (or even an Associate Product Manager) One of my clients is looking for a Marketing Assistant (or even an Associate Product Manager). If you know of anyone searching for a new opportunity, I would love to meet them! ******************************************************* Principal Catheter Design Engineer wanted to let you know about job openings at Medtronic Ablation Frontiers LLC in California that you might be interested in: Principal Catheter Design Engineer – California at Medtronic Ablation Frontiers LLC http://www.mydevicecareer.com/JD/R-AND-D-Science-Product-Management-California-MedicalDevice-Jobs-Careers-89501 Please *do not* send me a resume directly – you will need to apply online at the link above. ******************************************************** Apply on company website Sr. Supplier Quality Engineer- AccessClosure -Mountain View, CA Req# 13-5806 Exempt Regular Full-Time PROFILE: Ideal candidate is an independent, well-organized self-starter who thrives in a fast-paced environment and can independently juggle work priorities. A relationship-builder, you take a creative yet efficient approach to product quality, establishing supplier evaluation criteria and accountability. You are comfortable making decisions under pressure and exhibit a calm, efficient presence when faced with escalated turnaround times and/or sudden changes in daily work demands. SUMMARY: Responsible for the Supplier Quality Control system. Partner with internal departments and Suppliers to efficiently deliver safe and effective medical device designs and processes for manufacturing in line with AccessClosure’s policies and procedures. This includes supporting project teams on new and existing process and product development activities to

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ensure that processes and products are designed and developed in accordance with customer, corporate and regulatory guidelines. DUTIES & RESPONSIBILITIES: • Responsible for the management of the Supplier Quality System: o Supplier approval process including off-site manufacturing suppliers o Schedule and conduct Supplier audits, including off-site manufacturing suppliers o Present quality metrics as it relates to Supplier performance to Senior Management o Manage and investigate CAPA’s as they relate to Supplier quality performance o Direct interface with Suppliers relating to quality performance • Manage process improvements to the Supplier Quality System • Establishes measurement systems to monitor effectiveness of quality and reliability systems as they relate to supplier performance and component acceptance to identify, bracket, correct and prevent defects, presenting reports to management • Management of the NCMR system and facilitate MRB meetings • Assists with root cause analysis and corrective actions for Non-conformances related to components • Provide guidance to inspectors in the understanding of specifications, inspection technique and quality workmanship standards • Provides guidance to the engineering staff for the risk based approach to establish the sampling plan for components • Manages the quality related aspect for transition of manufacturing processes to off-site manufacturing suppliers • Represents the Quality department as a subject matter expert in External and Internal audits for Non-Conforming materials, Supplier Quality and other responsible areas • Assists with the document control process as it relates to components Requirements EDUCATION/EXPERIENCE: • BS in Engineering or related discipline • > 5 years related work experience with at least 3 years in the medical device field • Ability to perform multiple tasks concurrently with accuracy • Must have demonstrated hands-on experience in: o Auditing o FDA GMP o ISO 13485, 21CFR Part 820 • Clear and effective communication skills o Proficiency in MS word, Excel and PowerPoint o High attention to detail and accuracy is required • Working knowledge of SPC & Process Capability strongly preferred • Technical expertise in a commodity, such as extrusion or injection molding strongly preferred WORK ENVIRONMENT: • potential exposure to human bloodborne pathogens or other potentially infectious materials. • potential exposure to radiation sources such as fluoroscope in a catheter laboratory. • potential exposure to chemicals. • travel up to 25% (including some international) SUPERVISORY RESPONSIBILITIES: • May supervise Supplier Quality Engineers We are committed to promoting diversity in the workplace and embrace our responsibility to equal employment opportunities for all qualified individuals and are committed to providing

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accessibility to employment opportunities for individuals with disabilities. If you need technical assistance with the online application process, please call (650) 903-1000. ****************************************************************** For the opportunity below, please send resume to wd_darshana at hotmail dot com. Machine Learning Specialist - SF, CA Other opportunities are posted in JOBS category at the link below. darshanavnadkarni.wordpress.com Machine Learning Specialist - SF, CA Requirements: Minimum 5 years experience in creating high-performance classifiers, preferably working on biological data. Deep knowledge, skills and experience in machine learning techniques, in particular for processing large databases of biological information. Should be proficient and able to design, operate and validate intelligent systems from scratch. Excellent written, verbal and teamwork skills. Highly preferred: Relevant bio experience, such as working with biological signal databases; Experience in engineering for consumer devices/services; and Python expertise. Responsibilities: Lead the development of algorithms based on the signals from our advanced multi-sensing device, both in real time and on databases of saved sensor data; Work on top secret projects pertaining to future product offerings; Work closely science and devices teams to integrate the work into our consumer products. ******************************************************** https://jobs.smartbrief.com/action/listing?listingid=301FF649-3812-4CDC-A0EE-223AB40A20F6&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 REGULATORY AFFAIRS SPECIALIST Masimo Corporation Job Description Masimo (NASDAQ: MASI) headquartered in Irvine, California, is a fast-growing and award-winning international medical technology and device company with operations spanning the globe. We develop innovative, noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. These revolutionary technologies are helping to solve "unsolvable" problems that have plagued the healthcare industry, while taking the pain and discomfort out of blood monitoring. For more than 20 years, innovation has been and will continue to be our passion. To learn more about us, please visit: www.masimo.com Job Summary: In this high profile role, the Regulatory Affairs Specialist I will be an integral part of an expanding regulatory affairs team that is responsible for maintaining and documenting our mission critical domestic and international regulatory filings and registrations. From coordinating with international regulatory team members on product changes to maintaining up-to-date information on domestic regulatory requirements, the incumbent will be a key person in making it happen. The incumbent’s medical device regulatory expertise,

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organizational ability, and multi-tasking skills will be rewarded with opportunities for career growth and advancement in a company that makes a difference in people’s lives. Duties & Responsibilities:

Support the regulatory team managing international and domestic filings/registrations; Coordinate with international regulatory team members on product changes and

regulatory notification / approval requirements; Assist in maintaining product list on Certificate of Foreign Government; Maintain up-to-date knowledge on international and domestic regulatory requirements; Generate and maintain product compliance checklists; Provide regulatory support to the OEM Deployment group; Work with QA and Engineering in generating risk analysis, FMEA, and FTA reports; Submit document change orders (DRO/agile) for approvals; As requested by supervisor, represent RA department in project meetings and provide

regulatory guidance;

Update RA responsible quality system procedures as required (SQP/SOP’s); Performs other duties or special projects as assigned;

Minimum & Preferred Qualifications and Experience: Minimum Qualifications: Computer Proficiency with MS Office (Word/Excel/Access/Outlook);

Excellent verbal and written communication skills; Excellent prioritizing, organizational, and interpersonal skills; Excellent documentation skills including record maintenance/tracking and understand

document traceability; A detail-oriented individual with a “can do” attitude; Ability to work in a team environment as well as individually with minimal supervision; Ability to work in a fast-paced , Project Team environment, with multiple

tasks/projects; Preferred Qualifications:

Some previous work experience in a medical device Class II/ III environment; Experience in patient monitor systems, hospital-based products, software or electronic

device products; Knowledge of regulatory submission requirements for FDA Class II medical devices, and

equivalent classification requirements for international submission; Experience with FDA/GMP requirements for medical device; Experience in Quality Systems, per ISO 13485;

Experience with the UL/ETL certification process;

Experience interacting with regulatory bodies, such as the Notified Body; Education:

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High School or GED is required. Some college level coursework is preferred. BA/BS Degree is a definite plus. Physical requirements/Work Environment This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described. Masimo is proud to be an EOE, M/F/D/V, and we value and are committed to Diversity at every level. ********************************************************

http://bull.hn/l/12DW5/4

Contact me today about a Senior Clinical Data Manager opportunity in the South San Francisco, CA area! krista.leach@kellyscientific.com

Now Hiring: Senior Clinical Data Manager in South San Francisco, CA Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have a contract opportunity for a Clinical Data Manager for our client in South San Francisco, CA. The Clinical Data Manager will act as a core member of Study Management Teams and serve as the study data management contact at the study and/or program level, providing expert guidance to program teams. RESPONSIBILITIES: - Leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies -Interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met -Provides early strategic input into protocol design focused on data management issues -Leads the development of eCRFs and database development and testing specifications by interacting with other functional area representatives -Oversees all data review and cleaning activities involving close interaction with project clinical research professionals -Implements standards within Study Data Management across one or more CDM study teams -Develops and executes ad hoc database queries utilizing data review and query tools -Manages projects resourced externally via contract research organizations or corporate partners SKILLS: -Knowledge of core clinical data management applications Clinical data management systems, electronic data capture, query tools, web browser, MS Office suite

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-Clinical data management system experience EDC Medidata Rave preferred -Ability to apply advanced principles, theories and concepts for CDM as a whole -Understanding of the conceptual basis for data management conventions, standards and processes -Good understanding of the role of data management, biostatistics and statistical programming in the drug development process -Ability to develop solutions to complex problem -Ability to multi-task and effectively set own priorities -Strong organizational skills -Strong communication and interpersonal skills EDUCATION/EXPERIENCE: - B.A./B.S. or equivalent -Minimum of 5 years experience in Clinical Data Management If you meet the qualifications and requirements for this position, please Apply Now. Qualified candidates will be contacted.

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Dermatopathology Rep - Los Angeles

Now hiring: Dermatopathology Rep - Los Angeles http://www.ziprecruiter.com/job/Dermatopathology-Rep-Los-Angeles/3b8ddba7/?source=social-linkedin-group-jobs

******************************************************** Senior) Clinical QA Specialist – Contract or Full Time Position (San Francisco Bay Area) To view job description and other current positions please visit http://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Nicole@JGBBioPharma.com. No Work Visa sponsorship is available for this job. DESCRIPTION: The Clinical QA Specialist supports the Clinical Quality Assurance (CQA) management in developing its clinical quality systems and procedures. Assists in development of audit plans to ensure all trials are conducted in compliance with the study protocol, site procedures, and all applicable regulatory requirements. Assists with CQA audits of clinical sites, quality systems, clinical vendors and regulatory documents to ensure clinical trials are conducted per Good Clinical Practice (GCP) requirements. Assists with audit reports management and corrective action plan completion. Ensures work is carried out according to GCP standards as defined in the ICH Guidelines, corporate policies and procedures, and all regulatory requirements. Assists with development of CQA plans and implementation of the actions necessary to ensure clinical trials are conducted in accordance with the audit plan, GCP guidelines and regulatory requirement. Assists with conducting US and international sites, internal and external clinical systems and clinical vendor audits. Assists with all audits are followed-up and corrective actions are completed, implemented, and verified. Assists with investigations of GCP-related matters (i.e., product complaints). Assists with CQA quality systems and supports department infrastructure development;

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assist with creation/revision of appropriate CQA SOPs. Assists with GCP training activities. Assists in the review of regulatory submission documents (Clinical Study Report and Integrated Safety/Efficacy Summaries) and other essential documents (Protocol, Informed Consent Form, and Trial Master Files). Assists in the development of metric reports to CQA management of all issues related to the outcome of the audits. Facilitates CQA team meetings and discussions as needed. EXPERIENCE AND QUALIFICATIONS: Minimum BA/BS Degree in biological sciences, chemistry, or related field. 3+ years of pharmaceutical experience in a clinical development arena. 1+ year direct US and international Clinical QA auditing experience. Must be a team player. Excellent working knowledge and understanding of GCP-related requirements, proficiency of regulatory and ICH guidelines. Broad experience in the pharmaceutical industry with a strong clinical development background. Detail oriented with Quality Assurance and/or Clinical Development background with analytical and problem solving skills. Ability to work effectively in a fast-paced environment with initiative and great organization skills. Excellent verbal and written communication and interpersonal skills. Proficient with computers and word processing software (i.e., Microsoft Office products). Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com ******************************************************** Apply on company website If you wish to apply, simply click the ‘Apply’ button and fill out the form or email your resume to: resumes@sterlinglifesciences.com (no PDFs please) Senior Regulatory Affairs / RA Specialist Sterling Life Sciences- California (San Francisco Bay Area) Job Description See below for a job description / partial list of responsibilities. JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 1) Develop submissions for domestic US clearances 2) Work with various project teams and provide regulatory support to assigned teams as needed 3) Ensure for management of preparation and maintenance of US regulatory submissions and other pre-market filings and registrations to acquire appropriate commercial distribution clearances in an expeditious manner 4) Determine and document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with regulatory management as needed 5) Control and maintain regulatory records 6) Represent regulatory affairs on various design and development teams by attending team meetings and providing the required plans, procedures and regulatory decisions 7) Confer with other departments about the regulatory requirements of new product designs

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and changes to existing designs 8) Review and approve new documents and product changes for compliance and to determine if a new premarket application is required 9) Assist engineering in maintenance of design history files and related records on an as needed basis and where regulatory responsibilities permit 10) Review technical publications, articles and abstracts to stay abreast of regulatory and technical developments in the industry More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Regulatory-Affairs-California-Biotechnology-Jobs-Careers-89905 TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on

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Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://goo.gl/uTzVl We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). Remember: to apply for this position, click the ‘Apply’ button on Linkedin and complete the form. If you have trouble uploading your resume, email your resume to: resumes@sterlinglifesciences.com Additional Information Posted:March 13, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science, Project Management, Quality Assurance Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11171189905 Job ID:5101369 __________________________________________ Apply on company website Senior Regulatory Affairs / RA Specialist Sterling Life Sciences- California (San Francisco Bay Area) Job Description See below for a job description / partial list of responsibilities. If you wish to apply, simply click the ‘Apply’ button and fill out the form or email your resume to: resumes@sterlinglifesciences.com (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 1) Develop submissions for domestic US clearances 2) Work with various project teams and provide regulatory support to assigned teams as needed 3) Ensure for management of preparation and maintenance of US regulatory submissions and other pre-market filings and registrations to acquire appropriate commercial distribution clearances in an expeditious manner 4) Determine and document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with regulatory management as needed 5) Control and maintain regulatory records 6) Represent regulatory affairs on various design and development teams by attending team meetings and providing the required plans, procedures and regulatory decisions 7) Confer with other departments about the regulatory requirements of new product designs and changes to existing designs 8) Review and approve new documents and product changes for compliance and to determine

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if a new premarket application is required 9) Assist engineering in maintenance of design history files and related records on an as needed basis and where regulatory responsibilities permit 10) Review technical publications, articles and abstracts to stay abreast of regulatory and technical developments in the industry More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Regulatory-Affairs-California-Biotechnology-Jobs-Careers-89905 TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic,

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Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://goo.gl/uTzVl We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). Remember: to apply for this position, click the ‘Apply’ button on Linkedin and complete the form. If you have trouble uploading your resume, email your resume to: resumes@sterlinglifesciences.com Additional Information Posted:March 13, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science, Project Management, Quality Assurance Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11171189905 Job ID:5101369 _______________________________________________________ QC Manager ( Quality / QA ) Sterling Life Sciences- California (San Francisco Bay Area) Job Description See below for a job description / partial list of responsibilities. If you wish to apply, simply click the ‘Apply’ button and fill out the form or email your resume to: resumes@sterlinglifesciences.com (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 1) Establish Key Performance Indicators (KPI) and Quality Performance Indicators (QPI) for site quality and compliance operations 2) Manage the effective operation of the document control system and maintenance of the relevant records 3) Ensure effective external and internal audit programs and determine compliance with regulations

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4) Manage document for all company documentation (policies, procedures and controlled forms) including document change requests, notifications of new documents mastered 5) Participate in cross-functional teams to identify effective corrective and preventive actions to improve process quality 6) Conduct root-cause analysis for compounding errors and in-process errors generated at the facility during all phases of the production process 7) Ensure company and products are compliant with applicable regulations and laws More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Quality-California-Biotechnology-Jobs-Careers-89336 TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology,

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Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://goo.gl/uTzVl We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). Remember: to apply for this position, click the ‘Apply’ button on Linkedin and complete the form. If you have trouble uploading your resume, email your resume to: resumes@sterlinglifesciences.com Additional Information Posted:March 12, 2013 Type:Full-time Experience:Mid-Senior level Functions:Engineering, Quality Assurance, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11170189336 Job ID:5087427 ___________________________________________________ Apply on company website QC Manager ( Quality / QA ) Sterling Life Sciences- California (San Francisco Bay Area) Job Description See below for a job description / partial list of responsibilities. If you wish to apply, simply click the ‘Apply’ button and fill out the form or email your resume to: resumes@sterlinglifesciences.com (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 1) Establish Key Performance Indicators (KPI) and Quality Performance Indicators (QPI) for site quality and compliance operations 2) Manage the effective operation of the document control system and maintenance of the relevant records 3) Ensure effective external and internal audit programs and determine compliance with regulations 4) Manage document for all company documentation (policies, procedures and controlled forms) including document change requests, notifications of new documents mastered 5) Participate in cross-functional teams to identify effective corrective and preventive actions

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to improve process quality 6) Conduct root-cause analysis for compounding errors and in-process errors generated at the facility during all phases of the production process 7) Ensure company and products are compliant with applicable regulations and laws More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Quality-California-Biotechnology-Jobs-Careers-89336 TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology,

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Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://goo.gl/uTzVl We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). Remember: to apply for this position, click the ‘Apply’ button on Linkedin and complete the form. If you have trouble uploading your resume, email your resume to: resumes@sterlinglifesciences.com Additional Information Posted:March 12, 2013 Type:Full-time Experience:Mid-Senior level Functions:Engineering, Quality Assurance, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11170189336 Job ID:5087427 ******************************************************** Controller Alexza Pharmaceuticals- San Francisco Bay Area Job Description We have an exciting opportunity for a Controller on our team. This person will work closely with our Finance staff to transition our organization to commercial readiness. Responsible for the controller function in an independent corporation on a global, regional or country basis. Directs the accounting function, maintains fiscal records, establishes and maintains budgetary controls and procedures and prepares financial reports. Responsibilities: • Develop, interpret, prepare and administer the company policies, procedures and plans relating to all accounting and reporting matters, including revenue recognition and share-based compensation. • Manage the accounting systems, including the general ledger, accounts payable, accounts receivables, fixed assets and payroll. • Collaborate with the Executive Director, Finance and Manager, Cost Accounting in the areas of cost and inventory accounting. • Maintain and develop internal control structure including development and revision of accounting policies and procedures.

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• Lead the annual financial audits and quarterly financial reviews with the independent auditors. • Prepare and file the Form 10Qs and 10Ks, Proxies and annual reports • Work with our outside counsel to ensure we comply with all SEC reporting requirements (Form 8-Ks, Section 16, etc). • Manage the Sarbanes Oxley 404 compliance program. • Research accounting issues and prepare memorandums for management, the Audit and Ethics Committee and the independent auditors • Supervise, develop and train members of the accounting staff • Function as the Company’s stock administrator, including stock options, restricted stock units, share-based compensation, etc. • Manage governmental grant processes. • Assess and implement appropriate accounting and project systems. • Manage tax reporting and the tax return filing processes. • Review contracts for accounting implications. • Lead the annual 401K plan audits and compliance activities. • Manage relationships with various vendors such as the: auditors, transfer agent, outside counsel, etc. Desired Skills & Experience Skills required: • Excellent communication skills, both written and oral. • Ability to interface effectively with senior management, board members/audit committee and other internal/external contacts. • Strong attention to detail and confidentiality. • Ability to manage financials for multiple products/programs. • Advanced MS experience including Excel, Word, PowerPoint, and financial software programs. • Ability to work in a fast paced environment. Education and experience: • Bachelor’s Degree, CPA, 10-12 years of experience, with at least 2 years manager level experience at a Big 4 accounting firm • Strong knowledge of GAAP and ability to advise on technical accounting issues • Background with life science companies and government grants a plus We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment and excellent opportunity for career growth. Alexza Pharmaceuticals is an Equal Opportunity Employer. Direct Applicants only - NO AGENCIES, PLEASE. Company Description Alexza Pharmaceuticals, located in Mountain View, CA, uses our proprietary Staccato technology to develop CNS products to enhance patient treatment. The Staccato technology provides for the rapid but non-invasive delivery of drugs to treat acute conditions. Our products address unmet medical needs not currently addressed, for example, by either oral medications or injections. We recently received FDA approval of our first product, ADASUVE. You can read more about ADASUVE at www.adasuve.com. ADASUVE has received regulatory approval in the US and our application is pending final approval for Europe. As you can see, our approach is simple but elegant. We combine the proven Staccato delivery technology with known drugs that currently lack an optimal mode of delivery. Alexza hopes to write a new chapter in the ever advancing field of patient treatment.

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Alexza was founded by Alejandro Zaffaroni, a pioneer and visionary in the field of drug delivery. Through the years, Alexza has strived to maintain both the entrepreneurial spirit and very high standards set by Dr. Zaffaroni. Alexza has great technology and great people who are doing great things. Every individual in the company plays a critical role in Alexza’s success. Additional Information Posted:February 22, 2013 Type:Full-time Experience:Mid-Senior level Functions:Finance, Accounting/Auditing Industries:Pharmaceuticals, Medical Devices, Biotechnology Job ID:4950549 ******************************************************** Apply on company website VP | Sr Director Marketing - Early Stage Big Data Start Up Concurrent Inc.- San Francisco HQ (San Francisco Bay Area) Job Description Reporting to the CEO, the VP Marketing is responsible for WW Marketing, including corporate, field, product, online and customer marketing. This position is responsible for planning, organizing, staffing, training and managing all marketing functions to achieve Concurrent’s objectives of user adoption and sales growth while ensuring a marketing message and position consistent with corporate direction. Key Responsibilities:

Create and manage marketing campaigns to increase leads, opportunities, and upsell to existing customers

Promote campaigns and activities that increase web presence, visitor traffic, and lead generation

Understand, track and improve upon key marketing metrics Proactively identify, develop and drive longer-term marketing and communications

strategies and initiatives that will result in increased visibility and profitable growth Produce in-depth market assessment, sales information and customer retention data to

define gaps in business strategy and develop recommendations for action based on sound analysis

Develop the company’s marketing communications and brand strategy, and work with the Executive Team to establish corporate messaging and positioning

Convert business ideas and research into actionable product releases with an emphasis on revenue and performance

Work in close conjunction with the Sales organization and own the key messaging points around value proposition and differentiation, including the needs of different regions

Work closely with Product Development and Product Management to assist in prioritizing strategic direction and feature/product priorities

Speak externally to analysts, customers and trade journalists Achieve market share by developing and establishing promotional strategies; implementing advertising

Accomplish staff results by communicating job expectations, planning, monitoring, and appraising job results, coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing systems, policies and procedures; ensure that staff morale is positive to meet the sales organization's commitments

Desired Skills & Experience Experience leading a Marketing department in Enterprise Software Experience with marketing open source technologies and or freemium product offerings

is a big plus

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Experience with building and nurturing developer communities Minimum 10 years of experience in progressive Marketing roles at the senior

management level Must possess key competencies including strategic vision and analytical skills enhanced

by intuitive consumer insights Must have entrepreneurial and innovative DNA, willing to consider the outrageous and

respect the pragmatic Must have deep understanding of social media, viral marketing, the Internet and the

strategic marketing opportunities they represent Must be a team player and believe in the value of inclusion and collaboration Must be comfortable with the high growth/small company dynamic of rolling up your

sleeves and doing whatever it takes to get the job done given the constraints of time, budget and human resources

Strong leadership and motivational skills, responsive and flexible Ability to think strategically one minute and execute tactical details the next Focused on flawless execution Extremely resourceful, highly creative and high energy, able to brainstorm and

implement new ideas Demonstrated analytical, problem solving and decision-making abilities Ability to persuade and positively influence at all levels of the organization Ability to handle multiple projects in a fast-paced environment

Our ideal candidate would have all of the above; however, if you feel that your combination of skills, education, and experience positions you as a good fit, we'd love to hear from you. Company Description Concurrent is one of the hottest early stage Enterprise Big Data startups. Founded in 2008, Concurrent simplifies Big Data application development, deployment and management on Apache Hadoop. We are the company behind Cascading, the most widely used and deployed technology for building Big Data applications with more than 75,000 user downloads a month. Enterprises including Twitter, eBay, The Climate Corp and Etsy all rely on Concurrent’s technology to drive their Big Data deployments. Concurrent is funded by Rembrandt Venture Partners and True Ventures and is headquartered in San Francisco. Web - http://concurrentinc.com. Case Studies - http://concurrentinc.com/casestudies. Additional Information Posted:February 16, 2013 Type:Full-time Experience:Executive Functions:Marketing Industries:Computer Software Compensation:Competitive, Stock Options Job ID:4896527 ******************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5012906&trk=rj_em&ut=0h3l9OxVa9N5E1 Sr Marketing Product Manager NCompass Recruiting Services- San Francisco Bay Area Job Description Sr Marketing Product Manager Summary: Accountable for marketing activities supporting intravascular medical device business segment. Responsible for full life cycle management of the Product Line. Actively participates in the

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product development and platform global strategies. Establishes key customer relationships. Develops customer requirements, and proposes new product concepts. Acts as Voice of Customer in all decisions related to products. Promotes products through conferences, literature, clinical trials, and collateral development. Benchmarks competition and stays fluent with state of the art in clinical practice. Conducts detailed analyses of the Market and Sales Performance. Crafts impactful Business Models and Marketing Plans. Presents work to Senior Leadership. Essential Functions: Product Management

Identifies market potential, establishes pricing and market strategies, estimates potential sales, introduces segment products to market, manages distribution/channel issues, and manages mature product through phase-out.

Interprets and translates scientific clinical data for commercial utilization. Defines promotional activities along with sales, publicizing the product through the

press, sales force, and alternate distribution channels. Provides expertise in intravascular product area and develops strategies and applicable

portions of the company’s business plan. Plans, organizes, and coordinates assigned programs to ensure accomplishment of

financial/budgetary goals and optimum allocation of resources. Manages resources to execute assigned programs. Coordinates program planning with customer to ensure identification of appropriate

manufacturing schedules, goals, design criteria, costs, and similar considerations. Conducts pre-contract liaison with customer and may participate in negotiating with key

customers regarding contract terms and conditions. Coordinates details of program within the organization with a wide range of functions

and individuals. Coordinates product introduction and market exploitation with marketing and sales

organizations to ensure maximum penetration of market segment. Provides continuing product surveillance and management of established product to

obtain financial objectives. Interface with Research and Development in order to ensure that product development

efforts support the primary purpose. Lead the definition of new relevant products and upgrades to existing products. Build an identity and establish effective positioning, working closely with Marketing

Directors, Marketing Communications, Clinical Field Specialists, Sales Directors and Sales Training Staff.

Desired Skills & Experience Medical Device Marketing experience in the cardiovascular space is highly preferred. Company Description NCompass is a boutique recruiting firm specializing in contingency and retained Search for Medical Device companies throughout California. We have 10+ years of experience building successful teams in both start up and large company environments. Knowing that recruiting is no longer just about sourcing, we build strategic relationships with our clients and direct the hiring process through extensive discussions with executive management and hiring managers. Our niche focus allows us to leverage our industry expertise and drive strategic hiring so that the right candidate for the job and company is found and placed in a timely manner. NCompass Recruiting ServicesAdditional Information Posted:March 4, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing

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Industries:Medical Devices Job ID:5012906 ******************************************************** https://jobs.smartbrief.com/action/listing?listingid=4924B304-3585-430F-B029-AEAE1A2410F4&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Compliance Consultant 2 DJO Global Job Description DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices and services that provide solutions for musculoskeletal health, vascular health and pain management. We are currently seeking a Compliance Consultant 2at our Corporate Headquarters in Vista, CA. JOB DETAILS • Responsible for researching, monitoring and executing compliance tasks of intermediate scope, complexity and risk. • Participates in and provides compliance support for projects and initiatives with moderate risk to identify, assess and mitigate compliance risk in business activities. • Develops and implements testing methodologies to evaluate the effectiveness of compliance policies, procedures and processes. • Identifies, documents and reports findings and issues to compliance management. • Creates corrective action plans, communicates and manages the change to ensure compliance with federal, state, agency, legal, regulatory and internal requirements. • Works on special projects and audits as assigned EDUCATION & EXPERIENCE • Bachelors Degree required. • Minimum of 3 years of experience in compliance. • Knowledge of AdvaMed (or PhRMA) Code of Ethics preferred. • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. • Ability to be interactive with executives and other senior level personnel. • Ability to define problems, collect data, establish facts, and draw valid conclusions. • Computer skills: Excel, Visio, Word, Access. ABOUT DJO GLOBAL DJO Global is headquartered in San Diego, CA (Vista). The Company's products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company's medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. Our product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, electrical stimulators used for pain management and physical therapy products. Our surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. Our products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, Empi®, ProCare® and DJO® Surgical.

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DJO is a portfolio company of the Blackstone Group. EEO/AA-M/F/VET/HANDICAP ******************************************************** Posted by Harry Wachob, President & Founder of The Bio2Device Group Please give me a call (916) 835-1004 or send me an email regarding any of these roles. Send me your resume too. Greg Grichuhin Senior Recruiter Med Device Search Group (916) 835 1004 greg.grichuhin@gmail.com multiple opportunities Senior Manufacturing Engineer - San Francisco (CA) Company manufactures novel vascular devices. Need a Senior Manufacturing Engineer. Create and modify Processes. Small company environment. 300 employees and one location. This company is growing and exciting to work for. Polymer Scientist - Mountain View (CA) Company manufacturers vascular plug (PEG) to close femoral artery after surgery. Need an Engineer with knowledge of medical device polymers. Looking for someone who can develop new formulations AND help with manufacturing / process manufacturing. This is more of an Engineering role than a Scientist position. Staff R&D Engineer - Irvine (CA) Company manufacturers RF Ablation devices for heart procedures. The global organization has jobs open superstar candidates. Must have ME and have done at least one catheter based project from concept to commercialization. Senior Development Engineer - Mountain View (CA) Company makes catheter components and medical device tubing. Rapidly growing group. Heat shrink tubing and extrusions. Project R&D Engineer - Salt Lake City (UT) Company makes electrosurgial products for cutting and cauterizing tissue. The role is designing Arthroscopic instruments. Past instrument design experience with laparoscopic needed here. ******************************************************** Apply on company website Financial Planning Manager Allergan- Orange County, CA (Orange County, California Area) Job Description Reporting to the Director of Finance – R&D, the Financial Planning Manager is responsible for integrity of operating expenses and preparation of Global R&D organizational reports encompassing all constituents of R&D – Pharma R&D, Medical Device R&D, Regulatory Affairs, Phase IIIB, International Projects and Medical Affairs. Be responsible for Accounting and Financial Planning management for R&D. GL accounting oversight and reconciliation (P&L, Balance sheet accounts). In licensed deal and acquisition support. Preparation of Global R&D reporting encompassing all constituents of R&D – Pharma R&D, Medical Device R&D, Regulatory Affairs, Phase IIIB, International Projects and Medical Affairs. Proficient use of enterprise accounting and reporting systems (SAP BW, EPM). Global R&D Capital (Equipment and Facilities) support. Prepare Capital Strategic plan and forecasts. Representative for Global R&D needs and issues. Global facility overview and

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support – leasehold improvement projects, lab/vivarium changes etc. Interact with Allergan senior R&D and Corporate Engineering management and building landlords. Support the budgeting and forecasting processes for Discovery outside costs and departmental expenses, as well as analysis of variances. Work with executive leaders in Discovery to help manage financial performance. Actively participate in the data collection, review and consolidation of clinical study cost drivers to generate realistic, achievable study budgets. Using available system technologies (Cleartrial, SAP/BW), prepare appropriate analyses and reports for use by R&D Management. Act as finance liaison for select clinical study teams. Provide support and training to R&D personnel to ensure accounting and finance policies and procedures are understood. Ad hoc projects. Desired Skills & Experience Degree with emphasis in Finance, Accounting or Business Administration; MBA / CPA / CMA preferred. Current knowledge of finance and accounting practices and theories as they apply to broad cross-functional business decisions and plans. This level of knowledge would normally be acquired through at least five additional years of finance / accounting experience, preferably in a Fortune 500 company. 5-10 years financial planning experience preferably gained in the pharmaceutical industry. Excellent planning, organization and time / resource management skills, analytical and communication skills. Strong personal computer and systems skills, primarily in the areas of financial spreadsheets, modeling and database management, as well as presentation formats. Proficiency with SAP, Business Warehouse (BW) and Enterprise Performance Management (EPM) is preferred. Strong interpersonal skills, with an effective ability to influence others. Able to weigh costs / benefits. Proactively seeks out ways to add value / reduce work. Ability to work independently, with minimal supervision, under tight deadlines. Ability to function as an effective team member. High level of intellectual curiosity and flexibility. Company Description Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have approximately 10,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work. Additional Information Posted:March 15, 2013 Type:Full-time Experience:Mid-Senior level Functions:Finance Industries:Pharmaceuticals, Biotechnology, Financial Services Job ID:5130558 ******************************************************* Apply on company website

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Payroll and Benefits Administration Manager Pharmacyclics- San Francisco Bay Area Job Description The Payroll and Benefits Manager will implement, manage and administer all payroll and benefits programs. The individual will have direct responsibility for payroll processing, benefits administration, Federal and State compliance, public company/sox compliance, service reporting, cost management, and relationship management. PAYROLL

Ensure accurate calculation of wages, tax withholdings and company deductions. Perform accounting/general ledger functions as it relates to payroll and compensation,

i.e. balance sheet account analyses, journal entries, accruals and other month end close functions.

Identify and resolve discrepancies between payroll interface and the General Ledger. Work closely with Financial Planning & Analysis to produce compensation reports used

for the annual budget process . Deposit withholding taxes, file quarterly payroll tax reports, and manage W2 year end

process. Generate and respond to inquiries regarding paychecks. Processes bi-weekly payroll for US . Responsible for various payroll production processes (e.g. process new hires,

terminations, employee equity transactions, computing and processing time sheet data, pay rate changes, etc.).

Work with employees, internal departments (Finance, Accounting, HR, for example) and outside vendor companies to resolve problems and correct errors.

Respond to request for employment/salary verifications to the requesting organizations (mortgage companies, Federal/State agencies, etc.) according to established Company procedures .

Monitor changes in payroll tax laws to ensure compliance. Automate and streamline current processes when appropriate.

BENEFITS - Implement, manage and administer all employee benefit programs, including, but not limited to, medical, dental, vision, life, disability, COBRA, 401(k), Stock Options, ESPP, LOAs (FMLA, disability, personal, etc.), unemployment insurance, Workers’ Compensation, vacation and sick time, Flexible Spending Accounts (Section 125), etc.

Evaluate and compare existing employee benefits with the current market place and make specific recommendations.

Manage annual benefits renewal and conduct open enrollment (prepare materials and present benefit plan changes to employees).

Evaluate quality and usage of benefit programs. Research alternate benefit designs and deliveries. Conduct periodic financial analysis of benefit plans.

Plan, manage and conduct RFP process annually and as needed. Answer and/or research specific employee benefit questions. Investigate and resolve

discrepancies/issues working with employees, carriers and broker of record. Manage and process 401(K) plan administration, deferrals, loans and distributions

according to federal regulations and established Company procedures. Review, update and administer Company benefit programs and ensure compliance with

federal and state labor laws. Ensure legal compliance of all plans including timely and accurate ERISA and DOL filings such as 5500.

Work with EH&S team to accurately and timely report workers’ compensation claims; manage claims process efficiently; provide guidance to employees in returning to work.

Identify and resolve information system issues affecting benefits administration. Provide all required information to relevant department members and administer

benefits for new employees, current employees and terminating employees.

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Process timely enrollment/termination of employees in benefit plans and perform status changes.

Administer COBRA and LOA benefits timely and completely, ensuring all deadlines for required notices are met.

Coordinate stock option grants and ESPP enrollments. Plan and deliver education and wellness events (health fair, retirement seminars, etc.) Review and reconcile benefit related invoices for accuracy and process for payment. Maintain and upkeep required files following regulatory requirements.

Desired Skills & Experience Bachelor’s degree plus 5-10 years experience in a payroll and benefits role with

thorough knowledge of benefits and payroll principles. Prior experience as a Manager or Sr. Payroll & Benefits Administrator for a multistate,

publicly traded company. Experience with ADP HRIS and Payroll modules (HRB, Payroll, EZLabor, etc.) required. Certified Payroll Professional (CPP) certification or equivalent, required. In-depth knowledge in various areas of payroll (e.g. multi-state tax jurisdictions, equity

transactions, hypothetical tax issues, relocation, payroll systems, etc.), reporting and privacy issues.

Proven experience building, developing, and maintaining Payroll and Benefits policies and practices to support expansion and growth.

Experience with benefits administration, renewal negotiation, and open enrollment. Demonstrated knowledge of benefits programs, audits, filings (5500 and scheduled),

practices and related applicable laws. Strong computer skills in Microsoft Word, Excel, PowerPoint, and Outlook. Experience working in a fast-paced team environment handling multiple priorities and

tasks with professionalism, accuracy and efficiency. Demonstrated prior success in providing excellent customer service to all levels of the

company’s workforce. Ability to establish trust and confidence by maintaining a high level of credibility,

integrity, and excellent verbal and written communication skills. Ability to interface effectively with all levels of the organization. Ability to handle confidential and sensitive information appropriately. Effective conflict management, negotiation and time management skills.

Company Description Pharmacyclics (PCYC) Inc. is a mid-size biopharmaceutical company focused on discovering and developing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our pharmaceutical drug development candidates are designed to target key biochemical pathways involved in human diseases with critical unmet needs. Currently we have three drug candidates in clinical development and several molecules in preclinical development. This job candidate will focus on Ibrutinib/PCI-32765, first-in-human, oral therapy that is a selective, irreversible Bruton's tyrosine kinase (BTK) inhibitor being investigated in B-cell hematologic malignancies. PCI-32765 has initiated Phase 3 in CLL and demonstrated exceptional Phase 2 efficacy and safety data, with Overall Response Rates in the range of 60-90 % and a favorable safety profile in clinical trials. Additional Information Posted:March 16, 2013 Type:Full-time Experience:Mid-Senior level Functions:Finance Industries:Biotechnology Job ID:5130791 ******************************************************

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Posted by Amanda Rosales, Recruiter at SMR Group Ltd Email resume to alan@smrgroupltd.com Looking for specialty pharma reps w/ demonstrable over quota sales success in Fargo-Grand Forks-Bismarck, ND, Albany, GA, Lima, OH, Phoenix, AZ, Tucson, AZ, San Francisco, CA, Cincinnati, OH. ____________________________________________________________ Looking for specialty pharma reps w/ demonstrable over quota sales success in Denver, CO, El-Paso-Albuquerque, TX-NM, Morristown, NJ, Boise, ID, San Jose, CA, Hempstead-Melville, NY. ****************************************************** Posted by Harry Wachob, President & Founder of The Bio2Device Group Connie Milburn connie.milburn@att.net Marketing Assistant (or even an Associate Product Manager) One of my clients is looking for a Marketing Assistant (or even an Associate Product Manager). If you know of anyone searching for a new opportunity, I would love to meet them! ***************************************************** Apply on company website Payroll Specialist ZELTIQ- San Francisco Bay Area Job Description Reports To: Manager of Payroll, Compensation and Benefits Department: Human Resources FLSA: Non-Exempt Date: March 1, 2013 Summary: Process payroll for the company’s global employees. Track all accrued holiday/PTO and time taken on a domestic and international basis. Reconcile flexible spending and other benefit plans against payroll on a regular basis, as required. Reconcile state withholding taxes as required. Duties and Responsibilities include the following (other duties may be assigned.): The Payroll Specialist has primary responsibilities for ensuring that the Company’s payroll is processed accurately, timely and in compliance with the Company’s processes and controls. This includes:

Process Payroll for all Company employees, both domestic and international (presently U.S. and 7 countries in EMEA and APAC)

Ensure the appropriate calculation of all overtime for the Company’s non-exempt employees

Process any bonuses, sales commissions, and other earnings as necessary. Ensure appropriate approvals of all PTO requests through the Payroll system Assist in preparing month-end payroll journal entries. Reconcile payroll, PTO, flexible spending, and any other payroll related GL accounts. Investigate inquiries from taxing agencies (e.g. state tax departments, unemployment

insurance departments, etc.). Maintain appropriate controls, including verifying HR changes to the payroll system,

comparing roster of employees to pay register, etc. Desired Skills & Experience Qualifications:

This position requires a minimum of an Associate’s degree (A.A. or A.S.) or equivalent experience. Bachelor’s degree (B.A. or B.S.), or equivalent experience is preferred.

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Requires 3-5 years experience working in a payroll position in a mid-size company environment.

Ability to work with salary and other confidential employee information in an appropriate manner

Must have experience using an automated Payroll system for purposes of Payroll processing, reporting, approval and processing

Must have experience with international payroll, preferably Europe, Canada and/or Asia Moderate PC skills, especially Excel, Word, and Microsoft Outlook. Organized, detail oriented, and responsible. Ability to communicate effectively, orally and in writing, with all levels of employees. Ability to use word processing and database applications, and various software

programs such as Excel and PowerPoint. Company Description Founded in 2005, ZELTIQ® is a global medical technology company focused on developing and commercializing products utilizing our proprietary controlled-cooling technology platform. Our first commercial product, the CoolSculpting® System, selectively reduces stubborn fat bulges that may not respond to diet or exercise. ZELTIQ has exclusive rights to this innovative, “cool” approach to permanently removing fat. CoolSculpting is cleared for marketing in the United States. We also have received regulatory approval or are otherwise free to market CoolSculpting in 46 international markets. Additional Information Posted:March 14, 2013 Type:Full-time Experience:Mid-Senior level Functions:Human Resources, Finance Industries:Medical Devices, Health, Wellness and Fitness Job ID:5119859 *************************************************** Apply on company website Corporate Trainer Pharmacyclics- Sunnyvale, CA (San Francisco Bay Area) Job Description The Corporate Trainer will work as part of a team that delivers training in a number of formats to Pharmacyclics employees worldwide. Key Accountabilities/Core Job Responsibilities:

Identify and assess the training needs among Pharmacyclics employees and managers. Communicate with a variety of people including Pharmacyclics management. Coordinate training schedules with the customer and understand training demands. Establish the Training Institute within the organization Maintain positive relationships with all Pharmacyclics personnel and management. Keeps management informed of all area activities and of any significant client or

personnel problems. Demonstrate initiative by constantly looking for and recommending ways to improve

Pharmacyclics operations and/or customer service. Attends and participates in meetings as required. Develop, organize, conduct and evaluate training programs. Formulate training outline and determine instructional methods such as individual and

group training. Design or Facilitate training courses through online or onsite training sessions. Select or develop training aids such as training handouts, multimedia visual aids,

computer tutorials, and reference guides.

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Assist employees and managers with usage concerning “how to” perform specific tasks related to Pharmacyclics.

Develop strong relationship with all customers to develop course materials and receive feedback.

Help develop Pharmacyclics training material for new-hire internal training. Create teaching materials including training plans, handouts and visual materials. Amend and revise materials and/or training programs as necessary in order to adapt to

changes that occur. Facilitate the execution of all training plans including business and technical training for

new hires and/or current employees Train other trainers as the organization grows Plan, organize and implement a range of training activities. Present information using a variety of instructional techniques and formats such as role

playing, simulations, team exercises, group discussions, videos and lectures. Evaluate training effectiveness. Ensure all employees without fail have a training plan, that covers their basic corporate

training and on the job training according to their career path. Oversee all training schedules and ensure regular training is maintained. Maintain

training attendance records and report those back to management. Maintain training records.

Keep all up-to-date course material on file in online version of courses as applicable. Act as a supportive resource fielding questions about a variety of training topics. Act as a role model for all Pharmacyclics employees. Continuously increase knowledge in particular field and training by reading books,

journals and articles and attending meetings and training events. Adhere to all policies of Pharmacyclics including those outlined in the Pharmacyclics

Employee Handbook. Handle related tasks as assigned. Desired Skills & Experience BA/BS in Communications, Education, or Business

5-7 years training experience in a corporate environment delivering technical training and programs.

Previous training experience in the bio/pharmaceutical industry highly desirable. Well-versed in Windows and Mac and desktop software applications. Experience presenting to large audiences from all backgrounds. Demonstrated record of strong customer-facing skills and ability to build and sustain

ongoing customer relationships; ability to practice excellent customer service skills in a fast-paced environment.

Ability to present in front of a group, strong presence. Demonstrated ability to work within and team or independently with a high degree of

personal initiative and self-motivation. Ability to properly track and communicate problems, resolutions, and action items to

the customers and managers. Company Description Pharmacyclics (PCYC) Inc. is a mid-size biopharmaceutical company focused on discovering and developing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our pharmaceutical drug development candidates are designed to target key biochemical pathways involved in human diseases with critical unmet needs. Currently we have three drug candidates in clinical development and several molecules in preclinical development. This job candidate will focus on Ibrutinib/PCI-32765, first-in-human, oral therapy that is a selective, irreversible Bruton's tyrosine kinase (BTK) inhibitor being investigated in B-cell hematologic malignancies. PCI-32765 has initiated Phase 3 in CLL and

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demonstrated exceptional Phase 2 efficacy and safety data, with Overall Response Rates in the range of 60-90 % and a favorable safety profile in clinical trials. Additional Information Posted:March 14, 2013 Type:Full-time Experience: Mid-Senior level Functions:Human Resources Industries:Biotechnology Job ID:5118392 ___________________________________________________ Apply on company website Payroll and Benefits Administration Manager Pharmacyclics- San Francisco Bay Area Job Description The Payroll and Benefits Manager will implement, manage and administer all payroll and benefits programs. The individual will have direct responsibility for payroll processing, benefits administration, Federal and State compliance, public company/sox compliance, service reporting, cost management, and relationship management. PAYROLL

Ensure accurate calculation of wages, tax withholdings and company deductions. Perform accounting/general ledger functions as it relates to payroll and compensation,

i.e. balance sheet account analyses, journal entries, accruals and other month end close functions.

Identify and resolve discrepancies between payroll interface and the General Ledger. Work closely with Financial Planning & Analysis to produce compensation reports used

for the annual budget process . Deposit withholding taxes, file quarterly payroll tax reports, and manage W2 year end

process. Generate and respond to inquiries regarding paychecks. Processes bi-weekly payroll for US . Responsible for various payroll production processes (e.g. process new hires,

terminations, employee equity transactions, computing and processing time sheet data, pay rate changes, etc.).

Work with employees, internal departments (Finance, Accounting, HR, for example) and outside vendor companies to resolve problems and correct errors.

Respond to request for employment/salary verifications to the requesting organizations (mortgage companies, Federal/State agencies, etc.) according to established Company procedures .

Monitor changes in payroll tax laws to ensure compliance. Automate and streamline current processes when appropriate.

BENEFITS - Implement, manage and administer all employee benefit programs, including, but not limited to, medical, dental, vision, life, disability, COBRA, 401(k), Stock Options, ESPP, LOAs (FMLA, disability, personal, etc.), unemployment insurance, Workers’ Compensation, vacation and sick time, Flexible Spending Accounts (Section 125), etc.

Evaluate and compare existing employee benefits with the current market place and make specific recommendations.

Manage annual benefits renewal and conduct open enrollment (prepare materials and present benefit plan changes to employees).

Evaluate quality and usage of benefit programs. Research alternate benefit designs and deliveries. Conduct periodic financial analysis of benefit plans.

Plan, manage and conduct RFP process annually and as needed.

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Answer and/or research specific employee benefit questions. Investigate and resolve discrepancies/issues working with employees, carriers and broker of record.

Manage and process 401(K) plan administration, deferrals, loans and distributions according to federal regulations and established Company procedures.

Review, update and administer Company benefit programs and ensure compliance with federal and state labor laws. Ensure legal compliance of all plans including timely and accurate ERISA and DOL filings such as 5500.

Work with EH&S team to accurately and timely report workers’ compensation claims; manage claims process efficiently; provide guidance to employees in returning to work.

Identify and resolve information system issues affecting benefits administration. Provide all required information to relevant department members and administer

benefits for new employees, current employees and terminating employees. Process timely enrollment/termination of employees in benefit plans and perform status

changes. Administer COBRA and LOA benefits timely and completely, ensuring all deadlines for

required notices are met. Coordinate stock option grants and ESPP enrollments. Plan and deliver education and wellness events (health fair, retirement seminars, etc.) Review and reconcile benefit related invoices for accuracy and process for payment. Maintain and upkeep required files following regulatory requirements.

Desired Skills & Experience Bachelor’s degree plus 5-10 years experience in a payroll and benefits role with

thorough knowledge of benefits and payroll principles. Prior experience as a Manager or Sr. Payroll & Benefits Administrator for a multistate,

publicly traded company. Experience with ADP HRIS and Payroll modules (HRB, Payroll, EZLabor, etc.) required. Certified Payroll Professional (CPP) certification or equivalent, required. In-depth knowledge in various areas of payroll (e.g. multi-state tax jurisdictions, equity

transactions, hypothetical tax issues, relocation, payroll systems, etc.), reporting and privacy issues.

Proven experience building, developing, and maintaining Payroll and Benefits policies and practices to support expansion and growth.

Experience with benefits administration, renewal negotiation, and open enrollment. Demonstrated knowledge of benefits programs, audits, filings (5500 and scheduled),

practices and related applicable laws. Strong computer skills in Microsoft Word, Excel, PowerPoint, and Outlook. Experience working in a fast-paced team environment handling multiple priorities and

tasks with professionalism, accuracy and efficiency. Demonstrated prior success in providing excellent customer service to all levels of the

company’s workforce. Ability to establish trust and confidence by maintaining a high level of credibility,

integrity, and excellent verbal and written communication skills. Ability to interface effectively with all levels of the organization. Ability to handle confidential and sensitive information appropriately. Effective conflict management, negotiation and time management skills.

Company Description Pharmacyclics (PCYC) Inc. is a mid-size biopharmaceutical company focused on discovering and developing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our pharmaceutical drug development candidates are designed to target key biochemical pathways involved in human diseases with critical unmet needs. Currently we have three drug candidates in clinical development and several molecules in preclinical development. This job candidate will focus on Ibrutinib/PCI-32765, first-in-human, oral therapy that is a selective, irreversible Bruton's tyrosine kinase (BTK) inhibitor being

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investigated in B-cell hematologic malignancies. PCI-32765 has initiated Phase 3 in CLL and demonstrated exceptional Phase 2 efficacy and safety data, with Overall Response Rates in the range of 60-90 % and a favorable safety profile in clinical trials. Additional Information Posted:March 16, 2013 Type:Full-time Experience:Mid-Senior level Functions:Finance Industries:Biotechnology Job ID:5130791 **************************************************** Marketing Product Manager - San Diego Miltenyi Biotec, Inc.- Greater San Diego Area Job Description Miltenyi Biotec Inc., a global leader in biological magnetic separation technologies, is seeking a Marketing Product Manager in San Diego, CA to perform strategic marketing functions for designated product areas supporting corporate direction, communicating new product launch and coordinating tactical marketing projects. Responsibilities: • Perform strategic market analysis: market size and drivers, segmentation analysis, competitive landscape, opportunities and factors for success, etc. • Develop and execute comprehensive marketing plans and programs, both short and long range, to support sales and revenue objectives • Develop pre-launch and launch plans for new products for US and Canada • Develop and implement “how to sell” guidelines for sales representatives, including product rationale, positioning, competitive overview, companion products, etc. • Coordinate and participate in strategic discussions/activities with counterparts in Germany • Monitor competitive products and marketing activities • Develop rolling sales forecasts for new and current products • Establish and maintain relationships with industry influencers, key opinion leaders and strategic partners Desired Skills & Experience Requirements: Bachelor’s or graduate degree in the life sciences, Ph.D. or MBA preferred. Candidates must have in-depth technical knowledge and 5 years of experience in Stem Cell or Immunology/Hematology research areas; or equivalent combination of education and industry experience. We offer a competitive salary and excellent benefits package. There is no relocation associated with this position. EOE/AA Company Description Miltenyi Biotec, founded in 1989, has grown to over 1100 employees in 18 countries. The company develops, manufactures, and sells more than 1000 products and services; particularly in the fields of cell biology, immunology, regenerative medicine, and molecular biology. Miltenyi Biotec developed MACS® Technology, the gold standard method in magnetic cell separation. The ease and speed of the procedure combined with high purity and yield are some of its many advantages. MACS Technology combines the use of MACS MicroBeads (nano-sized superparamagnetic particles coupled to specific antibodies), patented MACS Columns, and MACS Separators. MACS Technology offers a multitude of applications: from small-scale to large-scale cell purifications, from cell to biomolecule separations, from lab bench to clinical

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research applications and separation of adult stem cells – for example, with the CliniMACS® Cell Separation System. The MACSmolecular Business Unit develops, markets, and sells innovative products for molecular biology research and provides bioinformatics and gene expression profiling services, as well as the generation of transgenic disease models. The TheraSorb™Therapeutic Apheresis product division offers unique medical instruments, adsorbers, and tubing sets for therapeutic apheresis. The Miltenyi Bioprocess division manufactures custom biopharmaceuticals, cellular products, medical devices, and related products and services. Our R&D departments are constantly developing novel reagents and instruments for use in immunology, cell and molecular biology, bioinformatics, and stem cell technologies – researchers working for researchers. The technical expertise of the employees is vast. It spans biological and chemical disciplines, including immunology, cell and molecular biology, hematology, regenerative medicine, organic and inorganic chemistry through physics and engineering, including biomedical, electrical, plastics and software development. Additional Information Posted:March 14, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing Industries:Biotechnology Job ID:5117331 **************************************************** Contact cheryl@biophaseinc.com if interested! Local candidates only will be considered at this time. If you are not local but plan to relocate, please let us know. Be sure to visit http://www.biophaseinc.com to view all our latest job opportunities. Senior Quality Assurance Specialist BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Senior Quality Assurance Specialist to work for a leading Bay Area biotechnology company. Senior Quality Assurance Specialist Position Description: Perform as a senior level lead in a quality environment, implementing, documenting and auditing the company’s quality system and compliance. Ensure documentation and auditing are performed for quality system procedures Perform failure investigations and corrective actions Prepare, review, approve and improve documentation for manufacturing and quality control Schedule or perform maintenance and calibrations on equipment Ensure products meet R&D specifications and quality standards. Operate lab instruments and software for data collection and analysis Promote and oversee design control, verification, and product validation Preparation, review, approval and improvement of documentation for manufacturing and quality control

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Ability to participate in audits for regulatory and customers. Update existing documentation to new regulations/standards. Input QA incident reports to automated system. Requirements: Bachelor’s degree in Microbiology, Molecular Biology; or related life science discipline with microbiology experience Minimum 4 years of related experience in Microbiology or Molecular Biology with significant knowledge of quality control operations Experienced with cGMP and ISO Familiarity with the preparation of published documents such as Certificate of Analysis and MSDS’s. Computer experience with MS office and ERP systems. Excellent skills in communication and time management *****************************************************

Jobs That Crossed My Desk through March 7, 2013 *************************************************** Posted by Harry Wachob, President & Founder of The Bio2Device Group FYI--Software Engineer Curexo Technology Corp. Fremont, CA Llink at http://goo.gl/r59D4 The Company is a pioneer in medical robotics and world leader in image-directed, robotic products for orthopedic applications. The Company’s product allows surgeons to pre-operatively plan their surgery in a 3-D virtual space and then execute the surgery in the operating room, exactly as planned. JOB DESCRIPTION The software engineer designs, implements, and integrates software for the ROBODOC system. The ideal candidate will have extensive experience designing and implementing C++ applications for medical devices. In addition, the ideal candidate will have a working understanding of FDA and ISO standards. • Works with software engineering team to develop software for robotic surgical assistant. • Design and implement user interface and workflow for surgical procedure. • Integrate algorithms and modules designed by other groups. • Design, implement, and validate C++ applications. • Follow rigorous design control methodology and write concise requirements specifications, architecture specifications, and design description, verification plans, and test cases. • Performs unit testing of software and assists in the verification and validation process. • Manages schedules, meet and adhere to development goals. • Provides planning and status information to project manager. This position may require less than 5% travel. Requirements QUALIFICATIONS • Must have 5+ years of experience in software development and developing applications with C++. • Must have 3 years of experience with medical imaging. • Must have 3 years of experience with algorithms development • Must have 3 years of experience with image processing. • Must have a strong working knowledge of object-oriented programming and system design.

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• Experience with multithreaded and multi-process programming. • Experience developing test procedures and testing modules. • Familiarity with VTK and ITK desired, but not required. • Excellent communication and documentation skills. • Bachelor’s degree in computer science or related field. ADDITIONAL INFORMATION Curexo Technology Corporation offers a fast-paced work environment, very competitive compensation, medical and 401K retirement plan benefits. ******************************************************* For more information and to apply please call or visit: http://jobs.cpspharm.com Phone (Toll Free): 877.806.7888, Ext:1238 - See more at: http://www.pharmacyweek.com/career/26640/Director-Pharmacy-California-Ca-Turlock#sthash.2Mm5ZY9S.dpuf DIRECTOR OF PHARMACY Emanuel Medical Center Turlock, CA DESCRIPTION As Director of Pharmacy with CPS you will have a full support team available to you. From a 340B Specialist, Regulatory Specialist, Drug Information Specialist, Operations specialists and more. We’ll rely on you to oversee all pharmacy operations including planning, organizing, controlling and supervising activities in the hospital pharmacy according to hospital policies, standards of practice of the profession, and State and Federal laws. PHARMACY The 24/7 Pharmacy is centralized with BMV and supported by Meditech and Omnicell. The Pharmacy is managed by Comprehensive Pharmacy Services (CPS). The Director of Pharmacy is an employee of CPS. All other pharmacy staff are employees of the hospital. FACILITY Emanuel Medical Center has been providing healthcare services to the community of Turlock since 1917. The current medical center includes a 206 bed acute care, not-for-profit community hospital, and offers state-of-the art services including emergency, critical care, birthing, pediatrics, cardiology, surgery, imaging, laboratory, rehabilitation, home health, hospice and community education. The hospital has a widely acclaimed cardiac surgery program and has just implemented a new Cancer Center. Emanuel Cancer Center is fully accredited by the American College of Surgeons’ Commission on Cancer in recognition of its stellar quality of treatment and care. Emanuel is owned by Evangelical Covenant Church. In addition to the acute care hospital, Emanuel also operates a 145 bed skilled nursing facility and a 49 bed assisted living facility. REWARDS CPS full-time employees enjoy a competitive salary and comprehensive benefits package, including Medical/Dental/Vision Insurance / 401(k) with a Match / Paid Time Off (PTO) including Paid Holidays / Company Paid Short and Long-Term Disability / Basic and Supplemental Life Insurance / Medical Flex and Dependent Care Accounts / Relocation / and More. QUALIFICATIONS

BS or PharmD degree from an accredited school of pharmacy California pharmacist licensure in good standing. Current or recent experience as a pharmacy leader in a hospital setting.

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Demonstrated ability to work independently, set priorities, make critical decisions, respond to client concerns and work cooperatively with other members of Comprehensive Pharmacy Services and hospital and pharmacy staff.

ABOUT CPS CPS is a pharmacy management services provider for 350+ acute-care hospitals, long-term acute care, behavioral health systems, and specialty hospitals in 47 states, Puerto Rico and the Virgin Islands. For over 40 years we have delivered pharmacy service value through financial, operational, clinical, therapeutic, and regulatory expertise. We’re growing at a breathtaking rate. As a CPS employee, you will discover, along with our other 1800+ employees, that CPS is a company you’ll be proud to grow with. ***************************************************** Posted by Taylor Langston, Social Media & Sales Support Specialist at PharmacyWeek, Inc. Director of Pharmacy DOP (206-bed), Emanuel Med Ctr, Turlock, CA CPS (Located 15 mi South of Modesto) http://www.pharmacyweek.com/career/26640/Director-Pharmacy-California-Ca-Turlock _____________________________________________________________ Area DOP, Eureka, CA Cardinal Health http://www.pharmacyweek.com/career/25276/Director-Pharmacy-Eureka-Ca-California-Ca-Eureka ________________________________________________________ Pharmacist II - Temp, Covina, CA Cardinal Health http://www.pharmacyweek.com/career/26652/Pharmacist-Ii-Temp-California-Ca-Covina ******************************************************* To Apply Online: http://jobsearch.covance.com/39333-jobs.aspx If link does not work: www.covancecareers.com (ref 39333 in search box) Medical Writing Communications Manager – Remote Position http://jobsearch.covance.com/39333-jobs.aspx Covance - San Diego, CA (Greater San Diego Area) Job Description The Medical Writing Communications Manager key responsibility will include developing and executing publications/communication plans for internal customers and external clients. This position can be a remote based role but will support our San Diego CA location. Essential Job Duties: - Develop and execute publication/communication plans for internal customers and external clients* - Develop abstracts and poster/oral presentations for data dissemination at major scientific meetings and congresses for internal customers and external clients* - Provide technical support at major scientific meetings and congresses for internal customers and external clients* - Develop manuscripts, white papers, and review articles for submission to high-quality, peer-reviewed journals for internal customers and external clients* - Act as primary client lead for medical communications-related activities* - Assist the Head of Value Communications in the development of the medical communications department for CMA - Provide editorial support as needed for internal customers - Mentor Value Communication junior staff to grow and develop their skills. Ensure they attend appropriate Covance, CMA, and client-specific training programs. Desired Skills & Experience Education/Qualifications

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- PhD in scientific field preferred with 3 years experience in medical communications, including at least 2 years in medical writing - Master in scientific field acceptable with 4 to 5 years experience in medical communications, including at least 3 years in medical writing Experience - Excellent verbal and written communication skills - Scientific knowledge of therapeutic areas - At least 2 years experience and participation in scientific congresses and meetings - Leadership potential - Knowledge of and experience with medical affairs-related activities - Knowledge of medical, pharmacokinetic, and statistical terminology - Ability to be detail-oriented and yet pay attention to global strategies and “the big picture” - Ability to be innovative and “think outside the box” to provide novel solutions for internal customers and external clients *********************************************************** Apply on company website Biomarker Project Manager - Clinical Trials Quest Diagnostics- Valencia, CA (Greater Los Angeles Area) Job Description Quest Diagnostics (NYSE: DGX) is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Currently, we have an opportunity available for a Biomarker Project Manager at our Valencia, CA location. Responsibilities As a key contact for Sponsors, this individual will: - Participate in CLW meeting process to ensure during the life of the study, requirements of the clients and projects are met - Provide pro-active monitoring on the study to ensure accurate clean data for the client. - Facilitate regular review meetings to discuss pro-active problem resolution of study specific issues utilizing the necessary resources from all relevant internal departments - Manage all service related issues - Ensure clear communication, expectations and deliverables with the study team - Discuss and agree on special handling procedures and ensure these are defined in study specific SOPs, and all relevant groups understand and are trained on the requirements. - Ensure set-up of study meets all applicable Quality Standards - Collaborate with counterparts to ensure global consistency on global study set-up. - Prepare weekly / monthly metrics and /or study status reports. - Attend internal and client audits - Act as back–up for Project Manager (set-up) as necessary - Enter and result of study testing verification report requests; interact with laboratory personnel including Alliance and referral laboratories regarding resulting of study testing verification reports, requests and issues - Perform other duties as required by management in support of customers and the broader clinical trials organization Desired Skills & Experience

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- BS (Science based) degree or equivalent education and experience. - 3+ years of clinical trials experience or experience in a clinical laboratory, either technical, customer service or support operations-related. Multiple experiences preferred. Company Description Quest Diagnostics Incorporated (NYSE: DGX) is the leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers physicians the broadest test menu (3,000+ tests), is a pioneer in developing innovative new tests, is the leader in cancer diagnostics, provides anatomic pathology (AP) services, & interpretive consultation through its medical & scientific staff of about 900 M.D.s & Ph.D.s. The company has about 43,000 employees, serves approximately ½ of all physicians & hospitals in the U.S., & reported 2009 revenues of $7.5 billion. Quest Diagnostics offers the most extensive clinical testing network in the U.S., with laboratories in most major metropolitan areas, & in Mexico, the UK & India. The company also operates four esoteric laboratories, 40 outpatient AP laboratories, & 160 smaller, rapid-response laboratories. Patients may have specimens collected in any of the company’s approximately 2,000 patient service centers. On a typical workday, testing is performed for about 550,000 patients. With its MedPlus subsidiary, Quest Diagnostics empowers healthcare organizations & clinicians with state-of-the-art connectivity solutions. The company is the leading provider of pre-employment drugs-of-abuse screening for employers & risk assessment services for the life insurance industry. It is the world’s 2nd largest provider of clinical trials testing for new pharmaceuticals. Additional Information Posted:March 6, 2013 Type:Full-time Experience:Mid-Senior level Functions:Project Management, Science, Health Care Provider Industries:Hospital & Health Care, Health, Wellness and Fitness Job ID:5046020 ********************************************************** Posted by Tom Hayes, Director Quality Assurance at Klein Hersh International Director of GMP plant compliance with a large cap client in the San Francisco Bay, CA area, contact me to learn more: 267-948-1440 Job: Director Quality Assurance in Castro Valley, CA A large cap pharmacuetical company is hriing in the San Francisco Bay area. If you are looking for a strategic leadership opportunity in pharma & medical device QA working as the head of compliance for a manufacturing facility keep reading! The Director of site compliancee - GMP will develop and deploy the quality / compliance program for a large manufacturing plant producing clinical and commercial Medical Devices (class I-III) and Biologics. This position oversees all quality assurance, quality engineering and quality control employees (roughly 100 FTEs). Responsibilities: •Assures systems and procedures for regulatory compliance are established and deployed. Periodically reviews the suitability and effectiveness of the quality system with executive management. Manages regulatory inspections. Acts as the Management Representative for Quality. Manages the Quality organization in a mid to large size plant. Builds up a strong performing Quality Organization with a clear vision and mission supporting growth and global

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expansion. •Directs large programs and departments in support of division or companywide initiatives. Is responsible for results in terms of product quality and conformance to regulations and company policies. •Develops and deploys the quality systems (e.g. management review, CAPA, design control, process control) that ensure products conform to defined requirements. •Understands and deploys processes to assure conformance to regulations in a mid to large size plant or a large programs or department. Manages regulatory inspections. •Periodically reviews the suitability and effectiveness of the quality system with executive management •Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability and cost improvements. •Assesses and advises senior management concerning acquisition targets. •Interacts frequently with all levels of internal management as well as across functions and franchises. •Manages interactions with customers and regulators concerning the quality of products, systems and processes. •Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility. •Develops budget for a mid to large size plant or large programs/ department and ensures adherence to the budget. •Manages overall coaching, training, development and succession plans for the team. Job Requirements In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics. Strong leadership skills and demonstrated success in managing a large team. Capable to manage in matrix and ability to interact successfully with multi-functions globally. Strong analytical, problem solving, and decision making skills •Excellent verbal and written communication skills •Success working with multifunctional, global teams. •Excelle... http://bull.hn/l/11USP/2 ********************************************

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Posted by David Kohl, Sr. Recruiter at Onyx Pharmaceuticals http://www.linkedin.com/jobs?viewJob=&jobId=5042955&trk=eml-anet_dig-b_premjb-ttl-cn&ut=05kHsI-dZ4yRE1 Sr. Manager, Clinical Data Management Onyx Pharmaceuticals- San Francisco Bay Area Job Description Essential/Primary Duties, Functions and Responsibilities

Recruits, trains and manages employees and consultants with area of responsibility; Develops training standards

Contributes to technical infrastructure of the Data Management and process improvement

Provides operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards while ensuring the Onyx established standards

Manages DM related timelines. Coordinates and synchronizes deliverables / milestones with the overall Study Execution Team timelines

Responsible for building effective DM vendor relationships for all assigned studies. Involved in RFP development, contract negotiation and selection of DM and/or technology, as needed. Escalates issues with proposed solutions, as necessary

Implements documentation and archival standards of Data Management deliverables including DM systems, databases, programs, and specifications

Implements methods of achievement of major reporting deliverables and milestones for regulatory submissions

Working with IT, ensures that local IT infrastructure meets Biometrics needs and global standards

Represent DM in Study Execution Team(SET) meetings; establishes and negotiates timelines with internal and external team members for completion of activities for a group of projects

Project management for DM deliverables for one or more projects as required Supports budget and resource planning across one or more projects Develops, applies and promotes consistent Data Management standards through

standard processes and SOPs Manages group of internal data managers, consultant data managers. Mentors and

develops direct reports provides training of the CRF completion guidelines, EDC system at Investigators'

meeting and to internal and external project members as needed Represents the DM function in external professional initiates and organization to identify

industry best practices May require travel up to 15% of the time

Requirements Work Experience:

Bachelor in Computer Sciences, Mathematics, Life Sciences with a minimum of 8 years of data management experience in the pharmaceutical or biotechnology industry plus 2 years of staff management experience, or MA/MS with 6 years of experience plus 2 years of people management experience

Minimum of 2 years in oncology Experience with an EDC system preferred Experience in working in and contributing to cross-functional teams

Education/Training: Requires Bachelors or higher in scientific discipline or equivalent combination of relevant

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educational and professional experience. Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted:March 6, 2013 Type:Full-time Experience:Associate Functions:Science Industries:Biotechnology Job ID:5042955 ________________________________________________________________________________ http://www.linkedin.com/jobs?viewJob=&jobId=5042955&trk=eml-anet_dig-b_premjb-ttl-cn&ut=3AuBdQDvhayRE1 Apply on company website Sr. Manager, Clinical Data Management Onyx Pharmaceuticals- San Francisco Bay Area Job Description Essential/Primary Duties, Functions and Responsibilities

Recruits, trains and manages employees and consultants with area of responsibility; Develops training standards

Contributes to technical infrastructure of the Data Management and process improvement Provides operational leadership to the direction, planning, execution, collection and handling of all

clinical data to the highest quality standards while ensuring the Onyx established standards Manages DM related timelines. Coordinates and synchronizes deliverables / milestones with the

overall Study Execution Team timelines Responsible for building effective DM vendor relationships for all assigned studies. Involved in RFP

development, contract negotiation and selection of DM and/or technology, as needed. Escalates issues with proposed solutions, as necessary

Implements documentation and archival standards of Data Management deliverables including DM systems, databases, programs, and specifications

Implements methods of achievement of major reporting deliverables and milestones for regulatory submissions

Working with IT, ensures that local IT infrastructure meets Biometrics needs and global standards Represent DM in Study Execution Team(SET) meetings; establishes and negotiates timelines with

internal and external team members for completion of activities for a group of projects Project management for DM deliverables for one or more projects as required Supports budget and resource planning across one or more projects Develops, applies and promotes consistent Data Management standards through standard

processes and SOPs Manages group of internal data managers, consultant data managers. Mentors and develops direct

reports provides training of the CRF completion guidelines, EDC system at Investigators' meeting and to

internal and external project members as needed Represents the DM function in external professional initiates and organization to identify industry

best practices May require travel up to 15% of the time

Requirements

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Work Experience:

Bachelor in Computer Sciences, Mathematics, Life Sciences with a minimum of 8 years of data management experience in the pharmaceutical or biotechnology industry plus 2 years of staff management experience, or MA/MS with 6 years of experience plus 2 years of people management experience

Minimum of 2 years in oncology Experience with an EDC system preferred Experience in working in and contributing to cross-functional teams

Education/Training: Requires Bachelors or higher in scientific discipline or equivalent combination of relevant

educational and professional experience. Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted:March 6, 2013 Type:Full-time Experience:Associate Functions:Science Industries:Biotechnology Job ID:5042955 ____________________________________________________________________________________ Manager, Study Builds & Clinical Data Programming South San Francisco, CA This oversight role is responsible for the delivery of study builds and clinical programming requests. Study builds includes the set up and deployment of technologies such as EDC, Coding, IVRS and Safety Gateway. This role will also be responsible for the development of SOPs and performance metrics related to Study Build and Clinical Programming. ___________________________________________________________________________ ******************************************************* Started by Ashley Reynolds, Program Manager at BIOCOM Institute For more information, visit www.biocollaborative.com. Free training for veterans to move from military into life sciences in San Diego. A group of San Diego companies are working together to help military veterans enter their industry. Now, the BioCollaborative Life Science Immersion Program in San Diego is helping veterans go from life on the battlefield to life sciences. "A lot of people in the military only see a life science career as a lab coat," explained Kristie Grover, executive director of BIOCOM Institute. That is one reason why they are having trouble filling the 100-plus spots for their online training course, which is free for veterans. About 40 veterans are in some phase of the roughly 100-hour course launched 18 months ago.

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The course is a much-needed tool to battle unemployment at 10.4 percent among local military veterans in 2011, and nearly 13.5 percent for veterans in the 18-34 age group, according to a recent report from the San Diego Regional Chamber of Commerce. The program not only connects veterans with mentors, but it follows up after the course with job opportunities and interview tips. The program is also open to non-veterans. *****************************************************

Respond via email: info@atilabiosystems.com Post Doctoral Scientist, Assay Development—Atila Biosystems, Mountain View

Position Summary: Invention of new assay techniques is central to this work. We are seeking a highly talented and motivated postdoctoral Scientist with experience in molecular diagnostics, specifically RNA and DNA diagnostic development. The ideal candidate will have experience in nucleic acid chemistry, real-time PCR, probe design, DNA Circuits design, and strong molecular biology skills. This position will be responsible for the development, optimization, qualification/validation, implementation, and writing technical reports, test methods, protocols, and other documentation of quantitative assays to support nucleic acid amplification and detection products, and enzymatic assays. Desired Skills and Experiences:

Ph.D. or MS. in Molecular Biology, Chemistry, Biochemistry, Analytical Chemistry, Bioanalytical Chemistry or related filed. Experience developing assays and kits for nucleic acid amplification and detection. The Scientist will develop and execute Nucleic Acid Diagnostic development, and sample collection/processing approaches. Experimental strategies include RNA and DNA preparation from tissue and other bodily fluids, RT-PCR based assay development relating to single base mutation detection, DNA circuit design, T7 transcription, cDNA synthesis. He/she may supervise Research Associates/technicians and coordinate with technical transfer of developed assays.

Expert proficiency in the use of standard molecular biology techniques (DNA amplification, real time PCR, probe design, BLAST, cDNA synthesis, T7 transcription).

Expert proficiency in fluorescent and luminescent assay detection platform, especially Real time-PCR and luminex platform.

Demonstrated success in developing and optimizing in vitro enzyme assays. In addition to impeccable technical skills, successful candidates should possess strong

organizational and communication skills, as well as be able to work within a team and thrive in a fast-paced start-up environment.

Responsibilities: This will be primarily a hands-on, bench level position with key responsibilities in the area of multiplex PCR based assays. The successful candidate must have a strong general science background in several disciplines and possess skills associated with IVD product development. This candidate will be involved in all aspects of assay development including design of nucleic acid isolation methods from different sample types, design of highly multiplexed, real-time PCR and RT-PCR assays, probe design and validation, creating and validating test methods, systems integration, capable of hands-on work at the bench as well as directing others to meet timelines successfully. About Atila BioSystems: Atila BioSystems, Inc. is a start-up company located in Mountain View, CA, developing novel technologies for molecular diagnostics. We are looking for energetic and highly productive scientists to join our fast-paced, goal-oriented team.

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**************************************************** To Apply: To respond to this position please visit: http://ejob.bz/ATS/jb.do?reqGK=662382 Biorepository Manager Insperity Client- Thousand Oaks, CA (Greater Los Angeles Area) Job Description BioStorage Technologies is the premier, global provider of comprehensive sample management solutions for the bioscience industry. We were founded in 2002 and are a privately held organization headquartered in Indianapolis, Indiana with an additional full-service site near Frankfurt, Germany. Our mission is to provide our clients with world class, biorepository services, exceeding clients’ expectations of service, value and quality while setting the industry standard for the storage, management and logistics of samples. Biorepository Manager of On-Site Solutions Utilizing your working relationships and leadership skills, you will provide direct, hands-on leadership of all Biorepository and Sample Preparation personnel. In managing these multidisciplinary personnel, you will ensure quality execution of Biorepository policies and procedures. You will also direct and implement the day-to-day tactical activities associated with Biorepository activities and Sample Preparation. We will rely on you to create and implement Biorepository and Sample Preparation policies and procedures which result in attaining departmental milestones and achieve high levels of client satisfaction. Responsibilities include:

Oversee day-to-day operations of Biorepository including: o Receiving and coordinating retrievals of materials coming into and leaving the

facility. o Contact and handling of potentially biohazardous materials including blood, body

fluids and other tissues from various sources (typically in a frozen state) o Working with biological materials at various temperatures o Data entry of information related to the biological materials into a proprietary

computer database o Sample preparation services as directed by customer of BST protocols

Provide leadership of multidisciplinary teams toward a common objective Responsible and accountable for all activities and outcomes of assigned personnel Responsible for overall fiscal management of areas of responsibility; ensure all

quoting/billing documents are harmonized and accurate Responsible for monitoring obligations in client master service agreements and

contracts to ensure that Biorepository and Sample Preparation activities meet these contractual obligations

Create actionable strategies that ensure the smooth and timely start-up, integration, and quality execution of Biorepository and Sample Preparation projects

Develop metrics and new business processes that align with a global strategy and achieve consistent high levels of client satisfaction

Propose recommendations and solutions that increase the likelihood of consistent operational success

Develop appropriate best practices resulting in standardized and streamlined global processes and efficient use of resources

Establish overall department vision and drive for continuous improvement initiatives, develop and monitor effective performance metrics, and coach and develop department members

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Work with other functional areas to develop and implement project and resource planning

Identify, monitor, and maintain the appropriate department resources to successfully achieve milestones and high levels of client satisfaction

Determine and monitor cost drivers to assist in prospective identification of profitability and resource planning

Balance workload within and across departments to meet operational and client requirements

Develop and implement an integrated and effective planning (resource planning, specimen project grouping, etc.) and forecasting tool

Develop, implement and monitor processes that strive for an effective balance between flexibility/customization and process efficiencies designed to work effectively across functional departments, to remove potential roadblocks and resolve organizational conflicts concerning people, resources, facilities, etc.; and that ensure appropriate escalation of issues and continuous, appropriate communication of issues across the organization

Communicate regularly with sales account managers for assigned clients; develop relationships with targeted clients

Ensure all service failures are identified, investigated, and resolved appropriately; proactively manage and drive the resolution of client issues; promote continuous process improvement

Work closely with the Sr. Director of Global Biorepository Operations and staff to develop strategic initiatives that focus on overall performance metrics, client satisfaction, and leading indicator mechanisms that are meaningful and drive quality and efficiency improvements

Provide general scientific and operational knowledge to Sample Preparation and Management

Ensure maintenance of all facility equipment including freezer units and generator is done timely and in accordance with BioStorage Technologies SOPs

Desired Skills & Experience Qualifications:

Bachelor’s degree in a Science related field required; Master’s degree preferred Fluent in English (verbal and written) Minimum 5 years of clinical laboratory experience Minimum 3 years of management and supervisory experience Excellent computer skills in MS Word, Excel and Outlook Proficient with Internet for research and working with companies, Strong orientation to detail Good working and communication relations with colleagues and customers Flexible and adaptable to changing work environments Demonstrated high level of initiative and ability to work independently Ability to organize, prioritize and manage workflow Ability to initiate and complete tasks Excellent problem solving skills

Preferred:

Master’s degree in science related field Multi-lingual Successful completion of graduate-level business courses Central laboratory experience

Working Conditions:

Working in an area with potentially infectious materials.

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Responsible for maintaining a clean work environment and enforce universal precautions for pathogens when working in an area considered to be potentially contaminated.

Some travel up to 10%, including international travel may be required. Benefits: We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.Additional Information Posted:March 5, 2013 Type:Full-time Experience:Mid-Senior level Functions:Engineering, Information Technology Industries:Information Technology and Services Compensation:Excellent Salary + Benefits Package Employer Job ID:662382 Job ID:5031030 *************************************************** Posted by Don Lim, Sr. Recruiter at Onyx Pharmaceuticals Apply Here - http://jobvite.com/m?3cUFJfwe Sr. Manager, Clinical Data Management | South San Francisco, California Join Onyx Pharmaceuticals, Inc.hire.jobvite.com *********************************************************** Director Business Development Adamas Pharmaceuticals, Inc.- Emeryville (San Francisco Bay Area) Job Description The Director of Business Development will be responsible for corporate partnering and alliance management activities and contractual relationships for the Company. The ideal candidate will be a business-minded operational leader who will bring strong corporate transaction, alliance management, and general operations expertise to Adamas. This person will also have responsible for managing critical supplier and contracts. This individual will lead our internal and external business development and partnering activites, and actively collaborate with product development, medical affairs and finance to achieve her/his objectives. This position will report to the CFO. Desired Skills & Experience Responsibilities:

Spearhead business development initiatives consistent with the Company’s overall strategy

Responsible for internal planning and execution of strategic partnering activities and alliance management

Responsible for managing all development and commercial aspects of outsourcing arrangements in support of the corporate strategy

Manage complex contract negotiations and work with outside legal counsel Working closely with the other members of the executive team, participate in strategic

planning and assist in development and management of the market and commercial assessments

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Conduct initial high level business fit and scientific evaluation of potential in-licensing opportunities to determine if they are worthy of further, detailed functional evaluation

Qualifications: At least 10 years in business/corporate development and transactions, with multiple

demonstrated successful partnerships at a high growth Biotech, Medical Device or related Healthcare company

Experience in evaluating in-licensing/out-licensing commercial opportunities through partnered collaborations

Excellent interpersonal skills Excellent verbal and written communication skills Excellent quantitative modeling skills Advanced degree (MBA or PhD) preferred

Company Description Adamas is a clinical stage pharmaceutical company focused on advancing its aminoadamantane-based therapeutics programs for disorders of the central nervous system, including Alzheimer’s disease and Parkinson’s disease. Adamas was founded in 2004 to develop new therapeutics for CNS disorders based on improvements to an underutilized class of drugs called aminoadamantanes, including amantadine and memantine. Today, with operations in Emeryville, CA and Bangalore India, Adamas is developing controlled release versions and optimized fixed dose combinations of aminoadamantanes to improve tolerability and clinical efficacy, and to provide superior clinical and health economic benefit. Adamas Pharmaceuticals, Inc.Additional Information Posted:February 26, 2013 Type:Full-time Experience:Director Functions:Business Development Industries:Pharmaceuticals Job ID:4884507 **************************************************** Apply on company website Dir, Product Marketing - 9572 Affymetrix, Inc.- Santa Clara, California (San Francisco Bay Area) Job Description Position Summary: Responsible for executing strategic product management responsibilities associated with current and future clinical molecular cytogenetic testing applications. This position will be accountable for product management and business activities pertaining to the relevant portfolio including, but not limited to, strategic product management and portfolio positioning of existing products, collaboration development, product and platform positioning, and marketing communication strategy. This position is also accountable for the creation of a portfolio strategy and roadmap to inform future product development decisions. New product development activities include financial business case development, market research, voice of customer, requirements development, core team leadership, and new product launch activities. This role interacts deeply with all internal business functions as well as customers, regulatory bodies, and global field-based personnel.

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The role requires a technical knowledge of cytogenetic applications and molecular genetics. Requirements: 1 Strategic product management and product lifecycle activities associated with existing and new product management 2 · Strong background in molecular diagnostic applications · Experience developing clinical products for regulated markets · Experience managing an integrated application & hardware platform (assay, software, and instrumentation) a plus 3 Key skills and competencies · Effective documentation of voice of customer / developing products for competitive advantage · Business case development / analytical capabilities · Effective participation in phase-gate product development processes · Direct experience developing clinical products for regulated markets · Superior communication skills · Excellent team player · Highly flexible and willing to take on new assignments in emerging focus areas · Strong cross-functional execution experience · Takes initiative without being coached · Excellent planning and scheduling skills · Knowledge of key accounts and key researchers 4 Partners closely with field sales teams and global business leaders to align strategic priorities and ensure a balanced approach to current and future product development activities. 5 BS/BA or Higher with experience in cytogenetics and/or molecular diagnostics MBA a plus 5 year+ related experience in marketing, sales, business development, or program management 7 Key competencies: · Strong cross-functional execution experience · Excellent communication skills · Takes initiative without being coached · Excellent planning and scheduling skills · Experience working in a structured product development environment Travel: 30-50% Primary Working Relationships: Reports to Clinical applications market leader. Works across functions including Field Sales and Marketing, Program Management, Manufacturing, Product Development, Finance, Legal, Quality Assurance, Regulatory Affairs, Corporate Business Development, Software development as well as with external business partners.

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Level of Autonomy and Complexity: Participates in department decision making in relation to procedures, continuing education for self and peers, and strategic business planning. Performs most job functions independently and at a high level, utilizing resources appropriately to fulfill job responsibilities in a cost-effective manner. Works independently and is highly motivated. Primary Duties and Responsibilities:

Directs the development of business and marketing plans and manages product lifecycles

Oversees market research, monitors competitive activity, and identifies customer needs Directs market opportunity and product requirements definition, pricing strategy and go

to market plan Monitors product development, working with R&D Provides forecasts and monitors resolution of product quality issues, working with

Operations Interacts with key thought leaders, working with Commercial Operations Prioritizes projects and resources based on business strategies Selects, develops, and evaluates personnel Leader of company operations, policies, and procedures Leads and works effectively with cross-functional teams Additional duties/responsibilities according to business needs

Requirements: Required Preferred Education:High School Bachelor's Yrs of related experience:8-10 years managerial Competencies: (skills, knowledge, abilities) Interpersonal skills, Results oriented, Change Leader, Understand complex scientific information Program Project Management Licenses/Certificates:None Travel Requirements:Up to 20% Working Conditions:Office Environment Level of Autonomy and Complexity:

Ensures meeting of operational objectives; contributes to development and execution of strategic company policies and objectives; finalizes decisions on administrative/operational matters

Works on problems that require deep understanding of company; contributes to development of evaluation criteria and techniques for projects; ensures budgets/schedules meet corporate requirements

Directs activities of managers in broad functional area; has control over goals, budget, staffing, planning, etc; recommends and institutes changes to practices

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Errors in judgment or failure to accomplish goals will have threatening impact on overall success of company

Additional Information Posted:February 20, 2013 Type:Full-time Experience:Director Functions:Marketing Industries:Biotechnology Employer Job ID:9572 Job ID:4931506 ***************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=4862242&trk=rj_em&ut=2bVSNy454py5E1 Pharmaceutical Director / Sr. Dir of Marketing - Oncology The Alpine Group- San Francisco Bay area Job Description Breakthrough science. Positive corporate culture. A start-up drug company is expanding their commercial team and needs a Director / Sr. Director of Marketing to lead their oncology franchise. This dynamic, high-growth organization has tripled in size in the two years and has three products in various stages of commercial and clinical development. If you have a strategic orientation and enjoy a creative challenge, this could be the opportunity for you. With a business model based on developing novel pharmaceuticals for critical, unmet medical needs, this is an exciting culture where their teams have unusually strong personal chemistry. And the dynamic nature of a start-up environment means that everyone is pitching in and working hard to get the organization to the next level. We are now looking for an entrepreneurial, strategic thinker to lead their oncology marketing team. The Role The Director / Senior Director will be responsible for all strategic and tactical marketing for a line of novel oncology compounds in the solid tumor segment. You will manage a team of three marketing professionals and lead the product lifecycle planning for their inline brands. Specific duties include market segmentation, positioning, branding, managing agencies for promotional programs and market research, and supporting the sales team. Your team will also develop Key Opinion Leader strategies and Medical Education programs, and will lead the Advisory Boards and Speaker’s Bureau. As new indications and products move through clinical develop you will also create and execute launch plans. This is a broadly defined role in a small, emerging organization where you will “wear many hats.” Other duties include coordinating the publication strategy and medical congresses with Clinical and Medical Affairs, assessing pre-clinical oncology pipeline opportunities, and developing reimbursement and pricing strategies. You will also analyze and track competitors for current and future indications of the oncology portfolio. This is a high profile, creative role requiring extensive commercial leadership, where you will interact on a routine basis with Senior Management. The rapidly expanding organization means there are significant opportunities for career development and advancement. Overnight travel is estimated at 20-25%. Desired Skills & Experience The successful candidate will have the following qualities:

10+ years of pharmaceutical or biotech industry experience in some combination of marketing, new product planning, and sales related assignments

8+ years of in-house oncology marketing experience, including product launch experience

3+ years of direct supervisory experience of oncology marketing personnel

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A willingness to be a “player-coach” in a leadership role that requires both strategic planning and tactical execution

Bachelor’s degree required; MBA preferred Company Description The Alpine Group serves only the Medical Technology industry, including the Pharmaceutical, Biotech, Medical Device and Diagnostic markets. Our clients choose us because we are specialists rather than generalists. As niche recruiters, we bring our clients market mastery, trusted counsel and - most of all - expedited results. Since 1999, we've helped over 125 different medical technology organizations hire Impact Players in positions ranging from individual contributor to Chief Level leadership. Our current client list includes large, multinational organizations like Novartis and Medtronic down to small, emerging organizations - including start-ups. The Alpine Group has achieved the MRI Network "President's Club" award for top 20% performing offices each of the past eight years, winning the Regional Office of the Year Award six times since 1999. Our recruiting approach differs from the majority of other recruiting firms. We invest time in getting to know about each candidate's career interests and qualifications and only then do we present an opportunity that might be a fit, rather than emailing a job description and asking who they may know that would be interested. With this approach we can not only match great people with great opportunities, but we also know when to contact them again when new opportunities arise that might be of interest. Our approach takes more time up front, but pays big dividends later for clients who need to hire quickly and candidates who appreciate the efficiency and candor. We think you'll find that the recruiting experience you'll have with us is different from what you may have experienced with other Search Consultants in the past. Give us a call and see what The Alpine Group can do for you! Additional Information Posted:February 12, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing Industries:Pharmaceuticals Job ID:4862242 ********************************************************* To apply, please use this link: http://www.mybiotechcareer.com/JD/Sales-Marketing-California-Biotechnology-Jobs-Careers-87928 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Director of Sales ( Business Development ) Sterling Life Sciences - California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Responsible for representing all company products, maintaining base business, acquiring new business and meeting or exceeding annual sales goals.

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2) Maintain call frequencies at hospitals, laboratories and physician accounts. 3) Represent the company to the customer in a manner that demonstrates the highest degree of integrity. 4) Attain a practical understanding of company products, methodologies and competition. 5) Utilization of good selling skills that allows for the identification of need and presentations based upon identified need. 6) Completion of tenders and presentations within assigned territory. 7) Have good understanding and working ability in Microsoft programs. 8) Strong relationship building skills with customers, vendors and co-workers. 9) Prompt reporting of competitive information and updates as to existing market conditions. 10) Update and adjustment of current customer base pricing. 11) Aid in the training and development of new sales employees. TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:March 1, 2013 Type:Full-time Experience:Director Functions:Sales, Business Development, Marketing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11159187928

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Job ID:5001080 ********************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=4950125&trk=rj_em&ut=2aLXuHmHojy5E1 Sr.Director/Director of Marketing Sciton, Inc.- Palo Alto, California (San Francisco Bay Area) Job Description Develop and implement worldwide marketing strategies to achieve corporate sales and marketing objectives. Lead 14 person marketing team. Reports to Executive Vice President, Sales & Marketing. Specific Duties and Responsibilities:

Coach/mentor marketing team members Identify market opportunities and mobilize resources to capitalize on them Drive the development of marketing materials and sales tools for the worldwide market Develop and implement marketing and promotional programs plus monitor and

evaluate them to determine their success Prepare launch plans for effective promotion of new products and applications

worldwide Cultivate relationships with key physicians worldwide Train worldwide sales and marketing teams Develop and work within program budgets Investigate new markets and play an active role in the product development function

for new applications, products and product improvements Develop knowledge of competitive products and companies and develop marketing

strategies to win against them Move Sciton to the forefront of digital and multimedia marketing Develop worldwide print and digital media plan Plan and execute worldwide trade shows Approximately 25-35% travel is required including international

Desired Skills & Experience 15 plus years of successful marketing or related business experience at consistently

more senior levels Demonstrated leadership skills Ability to work effectively within the Sciton team (Engineering, Manufacturing, Service,

Regulatory, Sales, Finance) Strong oral and written communication skills and project management skills Ability to execute against both short-term deliverables and long term strategic

initiatives Technical understanding of medical devices related to the aesthetic industry (lasers) Clear understanding of upstream and downstream marketing with emphasis on

downstream Successful track record in similar position BS or BA in Marketing, business or technical field MBA or other advanced degree preferred

Company Description Sciton is committed to providing best-in-class laser and light source solutions for medical professionals who want exceptional durability, performance and value. Sciton offers superior medical devices for fractional and full-coverage skin resurfacing, superficial and deep skin peeling, hair removal, phototherapy, wrinkle reduction, laser-assisted lipolysis, treatment of vascular and pigmented lesions and varicose veins, nail fungus, scar reduction and acne treatment. Additional Information

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Posted:February 22, 2013 Type:Full-time Experience:Director Functions:Marketing Industries:Medical Devices Job ID:4950125 Veteran Commitment

Sciton, Inc. commits to hiring returning veterans. Learn more » ******************************************************** Sales Area Manager/Sales Rep of Neurovascular Intervention Products Asahi Intecc USA, Inc. Job Description This position will be responsible for the sales of Neurovascular intervention products. Responsibility includes -Sales activity -Product training to phycicians and lab staff - Promotion and tradeshow support - Clinical case observation and market feedback - Marketing activity support Date Posted: 3/1/13 Location: Any location in US, CA Years Experience: +3 years in the neurovascular intervention ****************************************************** Apply today online at www.hemacare.com. EOE M/F/D/V Posted by Lou Juliano, Sr. Vice President, Research Products & Cell Therapy at HemaCare Corporation - Administrative Sales Coordinator (Los Angeles based) HemaCare Corporation is a blood products and services company serving healthcare providers and the scientific community for over 30 years and we are GROWING! We have an immediate opening for an energetic and motivated Sales Coordinator who wants to join our team and expand HemaCare’s ever increasing clinical research division. You will be supporting our Research Sales Team in different capacities. Our various market segments consist of Pharmaceutical, Biotechnology, Vaccine and Academic R&D. Essential Responsibilities • Assist with the processing and renewal of quotes. • Process and track large volume orders to confirm the receipt of the purchase order, ensure that the fresh cell products are placed on the demand or that cryopreserved products are

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available and that the order will ship on the promised date. Follow up with customer to ensure that shipment was received and that it meets the customer’s expectations. • Perform customer billing • Assist with receivable collections from new research customers • Help to create and maintain an updated customer database • Manage customer contracts • Create projects that correspond with the release of new products or special promotions to increase customer awareness and create sales opportunities for the sales representatives. Projects include the creation of a “customer contact list”, calling or emailing customers to measure interest, entering leads into customer database and forwarding to the appropriate sales rep. • Tradeshow management - Responsible for tradeshow registrations, shipment of materials and literature, arrangements for booth set up and all other aspects. Contact attendees to invite them to HemaCare booth. Assist with booth coverage, enter leads into customer database, forward “hot” leads that need immediate attention to appropriate sales rep and pre-qualify remaining leads by contacting customers to clarify their needs, products of interest and timelines. • Manage customer complaints. Address concerns as needed to achieve a win-win outcome. • Build customer database -search for new customers to build database by using websites of major universities, medical schools, research centers/facilities and biotech companies along with Navigrant, Google Scholar and other available resources. • Help create flyers or toss sheets for sales reps to use at vendor shows or visits to customers in the field. • Assist with the organization of Research Team Sales Meetings (arranging for meeting locations, activities, hotel reservations). • Run sales trend reports for SVP and Research Sales Team Desired Skills & Experience • Bachelor’s Degree in Business, Marketing, or Life Sciences • Experience supporting or working in a sales/customer support type role • Strong knowledge & use of all Microsoft Office products is required • Accounting experience is preferred • Goldmine experience is preferred HemaCare offers a competitive compensation package based on experience and excellent benefit package. If you like a challenge and want to be part of a dynamic growing team this job is for you! ********************************************************** For more information, please contact me at njs@nancysymonds.com, 415-491-1541. QA COMPLIANCE/SYSTEMS MANAGER/SR. MANAGER We are looking for external and internal auditing exerience and some experience developing systems. Travel is 30% mostly in the US. This is a ground floor opportunity to create a program for a small cell therapy company located on the Peninsula. Biologics experience preferred. ___________________________________________________________ QUALITY CONTROL MANAGER/SR. MANAGER This position requires flow cytometry experience and either cell therapy or gene therapy experience in your career history. Will manage 2. Client is a cell therapy company located on the Peninsula. Your referrals are so appreciated. For more information contact Nancy Symonds, President, NJS Recruiting Services, njs@nancysymonds.com, 415-491-1541. ******************************************************** Apply on company website

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Business System Analyst (SAP FI/CO) Mizuho OSI- Union City, CA (San Francisco Bay Area) Job Description Requires: 3-4 years of experience with SAP FI/CO modules and a Bachelor's degree in computer science or other applicable field. Who We Are: Since 1977 Mizuho OSI has been enhancing patient outcomes as the industry leader in the design and manufacture of Specialty Orthopedic Surgical tables and patient positioning devices. Mizuho engineers, working with leading Orthopedic Surgeons, continuously develop new surgical techniques to drive the market. Our company has a strong market share, is financially stable; and performed well and beyond expectations in 2012. Who You Are: You are a results driven, deadline smashing, analyzing and implementing machine. You eat, breathe and live SAP and you are an evangelist for positive change. Of course you are a great business analyst - you know how to independently analyze needs, scope out the results needed for a project, design, implement, train and support. You are particularly strong with the SAP FI/CO modules. You have proven yourself as a liaison between IT and Finance. You spend a lot of time listening, observing, documenting, and analyzing. When you speak, you are clear, concise, and present intelligent recommendations. When you write, people at every level of the business get the message and take action. Bachelor's degree in computer science or related field? Check. Three or more years of relevant work experience? Check. Experience working in an FDA regulated environment? Not required but we'd love to see it. Duties:

Meet aggressive deadlines with high quality results. Undertake extensive program and structural database development tasks. Review business requirements and detailed specs to develop test scripts and testing

plans with schedule. Develop work plans, managing deadlines and coordination of projects team and sub-

team activities. Work with different functional areas across the company to identify research and

resolve complex data issues, in a timely manner, with minimal impact to the integrated system.

Support integration efforts of Programs and Projects; set and control project scope. Create User Acceptance (UAT) test scripts to the approved requirements. Handle change requests and bugs resulting from the UAT process, ensuring completion

and retesting. Desired Skills & Experience Qualifications: Requires: 3-4 years of experience with SAP FI/CO modules and a Bachelor's degree in computer science or other applicable field or equivalent combination of education and experience. Company Description BENEFITS At Mizuho OSI, we believe better solutions and decisions are born of diversity and are proudly an EEO/AA employer. We offer a comprehensive benefits package that includes: medical, dental, vision, life insurance, 401k with matching, educational assistance and more. FOR OUR SERVICE MEMBERS AND VETERANS Mizuho OSI values the service Veterans and their family members have given to our country and we support the hiring of returning Service Members and military spouses. If you are a Veteran or wounded warrior and would like assistance with the employment process at Mizuho OSI, please contact Ron Katz, PHR at (510) 429-1500 x202. FOR PERSONS WITH DISABILITIES If you are a person with a disability or a disabled Veteran and are applying for a job with Mizuho OSI, we would like to ensure your application process goes as smoothly as possible. If

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you need additional assistance, information or answers to your questions, feel free to contact Ron Katz, PHR at (510) 429-1500 x202. MIZUHO OSI IS AN EQUAL OPPORTUNITY EMPLOYER Mizuho OSI is an Equal Opportunity Employer and makes business decisions based on job related criteria only. Company policy prohibits unlawful discrimination based on race, color, religious creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, sexual identity, or any other consideration made unlawful by federal, state or local laws. Additional Information Posted:March 4, 2013 Type:Full-time Experience:Mid-Senior level Functions:Information Technology Industries:Medical Devices Compensation:DOE plus annual bonus potential Employer Job ID:33-11a Job ID:5021346 ****************************************************** Apply on company website Senior Project Manger, Medical Device / IVD Alere, Inc.- San Diego, CA (Mira Mesa) (Greater San Diego Area) Job Description Position Overview: The overall responsibility of this position is to facilitate and manage all aspects of assigned projects including new product commercialization projects, on-market design changes and large scale quality initiatives. Interview dates for this role are planned for March 20thand 21st. Organization Chart: This role reports to the Program Manager of Project Management. No direct reports in the short term, possible future reports (Project Coordinators or Associate Project Managers). Major Functional Objectives:

Effectively manage the Cardiac Normalization team to the project plan and timeline with minimal supervision within 3 months. This project involves the creation of a new Design History File for an on-market product.

o Additional planning is required and should be completed within this 3 month period.

Ensure project team compliance with applicable company guidelines and regulatory requirements within 1 month.

o Complete all of the assigned Master Control training within a month Generate monthly project status reports including milestones, progress to plan, project

risks, project issues and recommended mitigations within 3 months. Analyze project schedule variances to recommend and implement corrective action

plans to eliminate or minimize schedule delays. Effectively manage a second project concurrently with the Cardiac Normalization project

within 6 months. Provide mentorship to junior staff members by guiding them through design control,

regulatory guidance questions and project strategy within 12 months. Subordinate Objectives:

Schedule and facilitate project team meetings to meet project goals. Schedule design reviews, generate meeting minutes and track action items to

completion.

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Develop, monitor and update project plans to ensure data integrity. Identify, analyze and provide possible solutions regarding resource and scheduling

conflicts between projects. Review project deliverables for consistency, compliance to procedures and

completeness. Process documents and labeling through the approval process. Provide guidance to Operations on On-Market Design Changes.

Management & Organizational Challenges: High expectations from Management in terms of project timelines with limited resources

and multiple competing priorities. Dynamic work environment resulting in routine shifting priorities and projects.

Changes & Improvements Necessary: Improve project design control deliverables to increase value to the project team and

compliance to the regulations by creating or working with others to create new design file structure, framing, or templates where needed.

Problems to be solved: Work with appropriate parties to manage and resolve project issues (technical,

resourcing, strategy, timing, etc.), getting people with different agendas aligned in an environment filled with complex information.

This role will need to influence across the organization at Supervisor to Vice President levels in Quality, Operations, Regulatory, Strategic Business Units (SBU), and other areas.

Technical Skills in actual situation: Knowledge of design controls needed to generate and execute a compliant product

development and commercialization project or an on-market design change project. Proficient project management methodologies and techniques to effectively manage a

cross-functional team to deliver to the desired goal. Team Skills in Actual Situation:

Collaborative. Knowledge transfer. Ensure the accuracy and effectiveness of inter and intra departmental communications. Interpersonal skills Influencing skills Troubleshooting skills Teamwork

Environment / Culture: The job holder will be resilient, determined to deliver results, with high energy levels. They should be able to handle complexity and changing circumstances and be able to

communicate effectively to a wide audience. The job holder should be receptive to working in a fast-paced, constantly changing work

environment that demands they step out of their comfort zone on a day to day basis. They must be able to stay calm in pressure situations and be able to influence others to

take decisions based on business needs. Desired Skills & Experience Basic Requirements:

Minimum of 5 years experience in the medical device industry or similar regulated environment with over 10 years overall experience in influencing and decision making roles.

Minimum of 6 years experience in project management. Understanding of design control strongly preferred. Understanding of manufacturing systems (documentation, compliance, inventory

control, production scheduling / controls, etc.)

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Working knowledge of federal and other applicable regulations. For example: QSRs, ISO, ISO 13485, and CMDR.

Proficient in the use of MS Office applications (Word, Excel, Project, Visio, etc.) Excellent written and verbal communications skills. Detail oriented. Minimum of BA or BS degree preferably in a scientific or technical discipline. Certification in Project Management preferred.

Company Description By developing new capabilities in near-patient diagnosis, monitoring and health management, Alere Inc. (NYSE: ALR) enables individuals to take charge of improving their health and quality of life. A global leader in rapid point-of-care diagnostics, our products, as well as our new product development efforts, focus on infectious disease, cardiology, oncology, drugs of abuse and women's health. Being a leading developer of innovative diagnostic and monitoring devices allows us to combine near patient monitoring tools with value-added healthcare management services in order to improve care and lower healthcare costs for both providers and patients. Alere is headquartered in Waltham, Massachusetts. Additional Information Posted:March 4, 2013 Type:Full-time Experience:Mid-Senior level Functions:Project Management Industries:Medical Devices Employer Job ID:03393 Job ID:5021920 ******************************************************* https://jobs.smartbrief.com/action/listing?listingid=4924B304-3585-430F-B029-AEAE1A2410F4&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Compliance Consultant 2 DJO Global Job Description DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices and services that provide solutions for musculoskeletal health, vascular health and pain management. We are currently seeking a Compliance Consultant 2at our Corporate Headquarters in Vista, CA. JOB DETAILS • Responsible for researching, monitoring and executing compliance tasks of intermediate scope, complexity and risk. • Participates in and provides compliance support for projects and initiatives with moderate risk to identify, assess and mitigate compliance risk in business activities. • Develops and implements testing methodologies to evaluate the effectiveness of compliance policies, procedures and processes. • Identifies, documents and reports findings and issues to compliance management. • Creates corrective action plans, communicates and manages the change to ensure compliance with federal, state, agency, legal, regulatory and internal requirements. • Works on special projects and audits as assigned

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EDUCATION & EXPERIENCE • Bachelors Degree required. • Minimum of 3 years of experience in compliance. • Knowledge of AdvaMed (or PhRMA) Code of Ethics preferred. • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. • Ability to be interactive with executives and other senior level personnel. • Ability to define problems, collect data, establish facts, and draw valid conclusions. • Computer skills: Excel, Visio, Word, Access. ABOUT DJO GLOBAL DJO Global is headquartered in San Diego, CA (Vista). The Company's products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company's medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. Our product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, electrical stimulators used for pain management and physical therapy products. Our surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. Our products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, Empi®, ProCare® and DJO® Surgical. ********************************************************** https://jobs.smartbrief.com/action/listing?listingid=376D8178-AF77-4ADE-860C-E682DEA973A1&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Sales Area Manager/Sales Rep of Neurovascular Intervention Products Asahi Intecc USA, Inc. Job Description This position will be responsible for the sales of Neurovascular intervention products. Responsibility includes -Sales activity -Product training to phycicians and lab staff - Promotion and tradeshow support - Clinical case observation and market feedback - Marketing activity support ********************************************************** Apply on company website Are You All That and a Chip Factory?!? Manager/Sr. Manager Global Marketing Communications Needed Onyx Pharmaceuticals- South San Francisco (San Francisco Bay Area)

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Job Description Do you enjoy working in a fast-paced environment? Can you adapt well to ever-changing situations? Can you communicate clearly and concisely to broad audiences inside and outside an organization? Are you a qualified professional with at least 5 years of marketing, writing, and/or pharmaceutical experience with a passion for learning? If you answered no to any of the questions above, this position is not for you. The Global Marketing Communications Specialist (GMC Specialist) position requires the advanced ability to collaborate and communicate across all levels and departments within our organization, as well as manage critical internal processes and execute highly visible tasks including copy editing and dialog facilitation. This is primarily a process management role requiring a well-seasoned individual who will work closely with product marketing management, regulatory, legal, and medical teams in the management of our promotional review committee (TROPIC) and medical review committee. Onyx Pharmaceuticals is growing at an accelerated rate, and the capabilities and responsibilities of the GMC team are expanding in line with that growth. Sound good to you? If you’d like to know more about this position and Onyx please read on, and if intrigued, apply! Desired Skills & Experience Essential/Primary Duties, Functions and Responsibilities:

Participates in the development of plans for product promotion in support of marketing objectives.

Supports communications projects in the areas of advertising and promotional programs, public relations and trade shows, including Internet-based communications.

Responsibility may include managing agency contracts as needed. May serve as editor for formal business communications.

Responsible for confirming TROPIC reviewer comments have been incorporated into final piece submissions

Review all TROPIC documents for editorial accuracy Collaborate closely with AOR and internal stakeholders to ensure implementation of

requested edits Track all pieces through the TROPIC process and provide status and output reports as

required Coordinate with warehouse liaison to ensure document delivery to archive Maintain electronic archival of all final pieces and related documents Facilitate electronic project work streams via Livelink Be familiar with and support the submission of marketing materials to external

regulatory authorities Work within the timeframe allowed to meet project timelines Serve as a resource to company personnel to allow appropriate access to documents

including retrieval and photocopying/scanning, or downloads of documents as requested Work Experience:

Minimum five (5) years successful pharmaceutical work experience. Preferably 2-3 years experience in marketing and/or communications

Previous exposure with field sales organizations. Previous experience with copy writing/editing preferred

Customer & Industry Knowledge: Previous work in biotech or biopharmaceutical industry is mandatory Previous marketing agency experience is preferred

Education/Training: Bachelor degree in Marketing, Communications, Journalism preferred

Other Requirements: Excellent verbal and written communications skills. Strong initiative and ability to multi-task.

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Resourcefulness and ability to handle multiple tasks/initiatives with a high attention to detail

Ability to learn quickly and take on new challenges as they arise Strong team player who leads by example Change management skills

Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted:March 5, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing Industries:Pharmaceuticals Job ID:4974409 ****************************************************** To apply: Visit http://tinyurl.com/b4ky8kr or www.BMRN.com Content Server Solutions Architect BioMarin- Novato, CA (San Francisco Bay Area) Job Description SUMMARY The Content Server Solutions Architect will have broad responsibility for BioMarin’s Enterprise Content Management platforms, including OpenText Livelink 9.7.1 and Content Server 10. This position is best suited for the person who thrives on new challenges and has the proven ability to make technology solutions work for the business challenges presented to IT by its clients. RESPONSIBILITIES • Architect, build, deploy and secure ECM solutions and equipment for internal customers. • Work with other ECM professionals to own, evangelize, and administer the ECM solutions used globally by BioMarin. • Develop, deploy, and maintain solutions in conjunction with business unit owners and cross-functional project teams. • Works with our external partners to manage operational issues of content management solutions, as well as being hands-on as required. • Understand business challenges and opportunities and drive new and innovative approaches to resolving them; Bridge the gap between business and technology to develop the right solutions for our clients. • Identify, recommend and implement technical solutions for application integration. • Deliver product, technology and/ or solution presentations to technical and business decision makers and engage interactively. • Lead and participate in project teams comprised of customers, partners, and peers from project inception through the hand off to operations as a technical subject matter expert. • Organize and lead user and technical requirements gathering and solution design sessions with customers, partners and other technical resources of all levels. • Practice disciplined execution focused on formulating solid vision, strategy, goals, and requirements collaboratively with customers and partners to ensure a well-defined opportunity with the right approach to executing on it. • Research and test emerging technologies to assist the business with developing strategic plans. • Provide ongoing systems support and enhancements once solutions are built and deployed.

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EDUCATION • BS/BA in related field or equivalent work experience. EXPERIENCE • 5-7 years related experience in designing, building and supporting advanced technical solutions on content management platforms. • Must be able to design and implement technical solutions to Enterprise business problems in a technology agnostic manner, but leverage existing platforms when it is the right choice to make. • Experience implementing and supporting Opentext’s document management system, Livelink/Content Server. • Must be able to think and deliver strategically while remaining proficient and engaged tactically with solutions. • Understanding of complex queries using Microsoft SQL. • Exposure to FDA or other regulated environments and ability to comply to such regulatory agency requirements. • Demonstrated ability to implement/upgrade/maintain systems within a rigorous change control environment. • Technical writing and verbal skills are required. • Candidate must be a strong team player recognizing personal improvement and awards are best achieved by making those around you successful. REQUIREMENTS • 2+ years in OpenText Content Server or Livelink development experience using Oscript, Workflows, Web/Live Reports, HTML, Java Script, Oracle PL/SQL • Impact analysis for upgrades, patches, and new enhancements • Familiarity with querying and organizing data using metadata • Development of LiveReports/WebReports •Experience with migrations, especially using 3rd party utilities such as Blubaker or Global Cents •Experience with any of the following: Livelink Builder, LAPI, OScript, Java, XML or Web services To apply: Visit http://tinyurl.com/b4ky8kr or www.BMRN.com Desired Skills & Experience EDUCATION • BS/BA in related field or equivalent work experience. EXPERIENCE • 5-7 years related experience in designing, building and supporting advanced technical solutions on content management platforms. • Must be able to design and implement technical solutions to Enterprise business problems in a technology agnostic manner, but leverage existing platforms when it is the right choice to make. • Experience implementing and supporting Opentext’s document management system, Livelink/Content Server. • Must be able to think and deliver strategically while remaining proficient and engaged tactically with solutions. • Understanding of complex queries using Microsoft SQL. • Exposure to FDA or other regulated environments and ability to comply to such regulatory agency requirements. • Demonstrated ability to implement/upgrade/maintain systems within a rigorous change control environment. • Technical writing and verbal skills are required. • Candidate must be a strong team player recognizing personal improvement and awards are best achieved by making those around you successful. REQUIREMENTS

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• 2+ years in OpenText Content Server or Livelink development experience using Oscript, Workflows, Web/Live Reports, HTML, Java Script, Oracle PL/SQL • Impact analysis for upgrades, patches, and new enhancements • Familiarity with querying and organizing data using metadata • Development of LiveReports/WebReports •Experience with migrations, especially using 3rd party utilities such as Blubaker or Global Cents •Experience with any of the following: Livelink Builder, LAPI, OScript, Java, XML or Web services To apply: Visit http://tinyurl.com/b4ky8kr or www.BMRN.com Company Description BioMarin develops & commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, & BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. EEO/M/F/D/V Additional Information Posted:March 5, 2013 Type:Full-time Experience:Mid-Senior level Functions:Information Technology Industries:Biotechnology Job ID:5025073 ************************************************** Posted by Dave Catlin, Managing Director To apply, submit resume to jobs@genquestbio.com Clinical Trials Project Manager - Biologics The selected candidate will oversee the conduct of all clinical studies performed and ensure studies are completed on time within budget and in compliance with SOP’s, FDA regulations and ICH/GCP guidelines. You will work as part of a cross-functional team to ensure completion of the project clinical goals and act as a primary interface with the CRO. You will manage communications between monitors, clinical sites and the CRO including the implementation and execution of clinical programs, development and administration of site and vendor budgets. You will coordinate with non-project finance and project planning staff to ensure accurate allocation of expenses, accruals and resources. You will assist in the writing of protocols, the design of case report

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forms and other study documents as you work closely with external service vendors to oversee all aspects of the clinical trials. You will evaluate, tabulate and may prepare written summaries of clinical data. You will ensure compliance with protocol, overall clinical objectives and FDA/IHC requirements including conducting a review and source verification of clinical data to ensure timely resolution of data queries. Maintain contact with clinical investigators and staff and track all required site documentation. Qualifications include a BS/MS degree or equivalent in the life sciences, or a related technical degree with 8+ years of experience. Experience managing multi site trials, CRO’s and other vendors is required. You should also have experience in Clinical Trial Management, specifically demonstrating application of research methodology in a clinical trial setting. You should have thorough knowledge of GCP/ICH requirements and possess excellent oral and written communication skills. This position may supervise administrative support and other clinical staff and may be required to travel to clinical sites occasionally. This is a contract opportunity for approximately 6+ months in duration with the potential to convert to regular status. No relocation is offered for this position. ************************************************ For more information MedicalDirectorJobs@beaker.com Gastroenterology (GI) specialty Location: Southern California Working for a specialty therapeutics and diagnostics Company, this position will direct the clinical development and medical affairs functions for the GI diagnostics and therapeutic product lines. In addition, they will serve as an internal thought leader and spokesperson on any medical information and inquiries about the Company’s GI product lines. Requirements: MD degree; ten (10) years direct experience in gastroenterology (board certified not required); in depth experience with managing clinical trials; ability to deliver and express value to Key Opinion Leaders (KOL’s); demonstrated knowledge of medical affairs. ****************************************************** Send your resume at samt@intanna.com Manufacturing Engineer with mechanical engineering degree Manufacturing Engineer (Medical Device) Title: Manufacturing Engineer with mechanical engineering degree Intanna Technologies Corporation is looking for Manufacturing Engineer with strong background in: 1) Design of Fixtures with Solidworks 2) Testing and validating parts and entire system with electronics inside (DVT and Validation). 3) System level experience in developing testing standards based on TUV, UL, FDA 4) Hands on person willing to work on the floor and participate for pre-production build 5) Analytical person who believes in statistical, six sigma and suggest clear path to launch products Requirement BS degree in Mechanical Engineering/Industrial Design/Manufacturing Engineering 5 to 8 years hands on exp. in product launch and manufacturing floor activities in medical device Hands on in product designing with plastics, sheet-metal and machined parts

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Other Information for Those in Transition ************************************************************************* *********************************************************************** Nice piece on informational interviews by Susan Oct. 22, 2012 at Work Coach Cafe at http://www.workcoachcafe.com/2012/10/22/how-to-do-successful-information-interviews/ Thanks to Paula Rutledge for sharing. ***************************************************************** Check out the annual Beyond Borders: Global biotechnology report 2012 on the biotechnology industry at www.ey.com. This is the 26th anniversary issue using consistent measures to track the industry sector. http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf *************************************************************** Check out the CHI.org website for the most recent publications on the status and trends of the California Biomedical Industry and workforce. These reports were prepared by leading organizations that research the market and lobby for the industry-- PWC, CHI and BayBio. They contain useful information for individuals as well as companies in researching the industry here locally. See 2013 report authored by CHI, PWC and BayBio at http://www.californiabiomedreport.com/ ******************************************************* Writing Resumes UC Davis Internship and Career Center Guide to Resumes (2011) Download at http://iccweb.ucdavis.edu/pdf/crm/0910/crm-resumes.pdf _____________________________________________________________ NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech Resumes 2.0, an Employer Perspective Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the Valley- Based on 250 employer surveys and over 50 executive interviews. As a portion of that effort, NOVA released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its dominance as the world’s preeminent innovation factory. Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters and hiring decision makers as well as practical employment search and resume tips, key messages for job seekers, employers, economic development leaders, educators, and workforce boards. A link to the report is http://goo.gl/uXTX7 ______________________________________________________________ Susan Caldwell wrote an article regarding writing a resume as well. “10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to

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develop and maintain a living resume that speaks to the best you have to offer employers. As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions: 1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database. Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history) Academic Background Skills Honors and Awards Publications There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position. 3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume. 4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your

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head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies. 5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny. 6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice. The remaining points in this article address issues within your resume's sections: 7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what you want to do in your next job. 8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.) A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous. As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history. 9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility. 10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can

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easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers. Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.

About the Author Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008. You can email Susan at caldwell@biotechink.com, phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account). Copyright 2009 Biotech Ink, LLC. All rights reserved. ___________________________________________________ “Writing Your Career Change Resume- 5 Tips,” Job-Hunt.org…your objective source of job search resources website; this might be helpful for those of you leaving a bench science position to another function inside a life science company. http://www.job-hunt.org/career-change/resume-for-career-change.shtml I googled several questions about writing a resume and was astounded that the different sites with free advice, templates, etc. Of course, some service providers were also listed. I googled Amazon’s top books for job hunters and writing resumes and found a list including one of my favorites What Color Is Your Parachute? 2013: A Practical Manual for Job-Hunters and Career-Changers by Richard N. Bolles. I found this book especially useful in helping me determine what types of job functions I liked best. ************************************************************************* Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • enewsletters@fdanews.com PharmExecBlog.com at http://blog.pharmexec.com/ on the business of pharma http://realendpoints.com/blog/ on pricing and reimbursement

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Luke Timmerman’s blog on Xconomy. ********************************************************************* Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.” The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50-make.html?WT.mc_id=EM3965M&WT.dcsvid=1541418993. ************************************************************************* Job Sites Review my weekly listings for individual recruiters and review their websites where they post jobs. Be sure to join the Bio2Device Group and their Linked In Groups where jobs are posted. There are specialized linked in groups that list jobs in the area of interest to its members. I’m a member of separate linked in groups in marketing and marketing research where I gather jobs for my weekly postings. The most known site for career and job listings is www.biospace.com which focuses on biotech and pharma. There’s another site which is focused on life science recruitment and placement; note featured company listings may be listed—www.beaker.com There’s website with jobs specific to medical device area at the www.legacymedsearch.com. Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at wd_darshana@hotmail.com. You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. ************************************************************************* Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order: 1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/

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7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://www.the-scientist.com/?articles.view/articleNo/32918/title/Life-Sciences-Salary-Survey-2012/ Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies at http://www.contractpharma.com/contents/view_salary-survey/2012-06-19/2012---thirteenth-annual-salary-survey/. The most recent Medtech survey for R&D can be found at http://www.mddionline.com/article/more-work-fewer-perks-medtech-employees. You can also find salaries for other functions at the same location. MM&M reports salaries in the September issue each year. See 2012 results at http://media.mmm-online.com/documents/40/2012_survey_9911.pdf ************************************************************************* Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at www.careersbiotech.com. This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities. The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com/blog along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@aol.com if they wish to receive these mailings directly. *************************************************************************