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regulatory affairs in San Francisco Bay Area

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  1. Discoverant Technical Lead at LabAnswer

    Knowledge of regulatory requirements. Opportunities to work across a variety of laboratory environments (analytical testing, biotech, clinical trials, forensics...

  2. Lead Catastrophe Modeler (Mathematical Modeling, Catastrophe Modeling, GIS) at Risk Management Solutions (RMS)

    C#, Java, R, Python. In an engineering or science related field including but not limited to:. Civil, structural or earthquake engineering, statistics and...

  3. Client Services Associate at Counsyl

    There are three teams within the Client Operations department-- Inbound Billing, Inbound Support, and Outbound Support. This department is integral to Counsyl

  4. Senior Data Engineer, Bidding at Marin Software

    Statistical Programming (Matlab, R, Python). We enjoy intense mathematics and computer science challenges and approach these problems with creativity and...

  5. Principal Engineer Bioanalytical Technologies at BAYER

    Broad understanding of biotech manufacturing processes (mammalian cell culture, protein purification, fill/finish processes, process monitoring/control);...

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    1. Associate Director, Medical Communications Full time 2015-1329

      Description:Key member of the global medical affairs team, providing leadership and management of the publication management team and assist with providing oversight to the staff to ensure high quality managed medical communication programs with the appropriate utilization of resources.Has administrative and functional oversight of the responsibilities of employees in medical communications ...

    1. Medical Writer(s) / Senior Medical Writer - Oncology, Hematology at Alexander Bec

      Work with the nonclinical team to prepare nonclinical reports, and nonclinical sections of various documents · Work with Regulatory Affairs department to...

    1. Global Clinical Research

      My name is Jessica, and I represent The Fountain Group.  We are a national staffing firm and are currently looking to fill a Global Clinical Research  position for a prominent client of ours. This position is located in San Francisco, CA.  Job Description: Responsibilities:Supporting the Protocol Execution Team (PET) / Study Management Team (SMT)Supporting Cross Functional Teams such as Data ...

    1. Director of International Regulatory Affairs at Real Staffing

      You will head up the international regulatory affairs group and will work closely with the head of US regulatory as well....

    1. Sr. Regulatory Affairs Associate

      Sr. Regulatory Affairs AssociateCheck out all our open positions @: www.scientificsearch.comScientific Search client has an immediate need for a highly talented and self- motivated professional to join their team as a Sr. Regulatory Affairs Associate. This is a full time direct hire opportunity with dynamic organization.We are seeking a detail oriented person that is ready to prepare and ...

    1. Regulatory Affairs Senior Specialist - Ad Promo - IVD at Real Staffing

      Our retained client in the East Bay Area is looking to add a specialist or manager of regulatory affairs, ad promo....

    1. Director Regulatory Affairs

      Relocation Assistance: NoMust have United States Citizenship Oversee the Regulatory Affairs activities in the company’s enterprise and businesses including Dako.Develop the global organizational regulatory strategies, implement and monitor the regulatory strategies and activities.Evaluate current processes & procedures and implement new and necessary improvements and additions.Build-up of an ...

    1. I&C Systems Engineer (Biotech) at Day & Zimmermann

      CGMP, PLC, SCADA, biotech:. _Experience in the design of instrument, control, and low voltage (480VAC and under) electrical systems for pharmaceutical/biotech...

    1. Clinical Trial Manager

      Postion can be 100% remote. 6 Month renwable contract.SUMMARY:The Clinical Trials Manager II is responsible for the day-to-day oversight or performance of operational tasks related to the conduct of 1-4 clinical trials commensurate with complexity, including trial start-up, conduct, and close-out activities in accordance with the protocol, Standard Operating Procedures (SOP), Good Clinical ...

    1. Manufacturing Associate II-Purification at Real Staffing

      Small-medium sized biotech working on one-of-kind product and technology. We are looking for an entry level professional who has at least three years of...

    1. Clinical Trial Manager  /  Study Manager  -  98392

      Job Title: Clinical Trials Manager Job Description:The Clinical Trials Manager II is responsible for the day-to-day oversight or performance of operational tasks related to the conduct of 1-4 clinical trials commensurate with complexity, including trial start-up, conduct, and close-out activities in accordance with the protocol, Standard Operating Procedures (SOP), Good Clinical Practices ...

    1. Senior Data Scientist, Big Data Analytics at Genomic Health, Inc.

      Experience with common data science toolkits, such as R, NumPy, MatLab, SAS, etc. Mastery of at least two of them is highly desirable....

    1. Senior Clinical Study Monitor - Sr. Clinical Research Associate 98202

      Job Description:A Senior Clinical Study Monitor - Sr. Clinical Research Associate is needed for a 6-month, renewable contract position at major biotech in Northern California.About Client:My client is a leader and innovator in healthcare diagnostics. They are consistently rewarded for their research, which provides patient’s with tailored, integrated solutions. It is a growing and stable ...

    1. Director, Regulatory Affairs at Sterling Hoffman Life Sciences

      Prepare regulatory filings and maintain regulatory requirements. Preference will be given to people with recent experience in regulatory affairs management....

    1. Clinical Study Monitor - Clinical Research Associate (CRA) (98202-1)

      Job Description:A Clinical Study Monitor - Clinical Research Associate (CRA) is needed for a 6-month contract position at major biotech in Northern California.About Client:My client is a leader and innovator in healthcare diagnostics. They are consistently rewarded for their research, which provides patient’s with tailored, integrated solutions. It is a growing and stable company that is ...

    1. Account Manager, Trade Relations Specialty Pharmacy-Field Based at Alkermes, Inc.

      The Account Manager, Trade Relations Specialty Pharmacy-Field Based will assume daily responsibility for assigned accounts to address contracting, product

    1. Director, Regulatory Affairs – San Francisco Bay area

      1- Director, Regulatory Affairs – San Francisco Bay area MUST HAVE: Oncology, Hematology. Ph.D NOT required, preferred. Must have experience writing briefing books and have filed an NDA. SUMMARY: Reporting to the Vice President, Regulatory Affairs, this position will manage the day-to-day regulatory activities of assigned projects for compounds under development. These ...

    1. Associate Client Relationship Manager - Ultradata at D+H

      Bachelor’s degree in Business o r equivalent experience. The Associate Client Relationship Manager will generate revenue by selling software solutions and...

    1. Principle Scientist

      PRINCIPAL SCIENTIST – DQA SW/System TempProvide design control and software/systems development guidance to new and, or revised product development teams and life cycle teams and be the single point representative for Design Quality Assurance activities focus on regulation compliance for the Project Teams dealing with system and software products.Review and approve documentation consistent ...

    1. Senior Director of Regulatory Affairs at Sterling Hoffman Life Sciences

      Direct regulatory affairs related activities for the company. Act as a company representative and interact with regulatory agencies, while supporting continual...

    1. Scientist - Protein Analytical Development

      Scientist - Protein Analytical DevelopmentLocation: Berkeley/EmeryvillePRIMARY PURPOSE OF POSITION: As a member of the Analytical Development team, this position will support early- to late-stage development focused on protein analytics and characterization. The successful candidate may develop, transfer, and validate protein analytical methods for drug substance and drug product release, ...

    2. Senior Clinical Financial Analyst 1134

      Financial liaison with Clinical Research & Development and Regulatory Affairs & Compliance and the finance department.  Responsibilities include budgeting and forecasting, project tracking and accounting and monthly close responsibilities.   Works closely with department managers and ensures the accurate and timely processing of monthly accruals, accounting entries, budgeting and forecasting ...

    3. Associate Director, Regulatory Affairs

      Specific Responsibilities and skills for Position The Associate Director will be the global regulatory lead for the HIV therapeutic area marketed products Stribild®, Tybost®, and Vitekta®, as well as product in development in the field of HIV. The Associate Director, working with the US, EU and other regional regulatory leads and the project team, will develop global regulatory strategies, ...

    4. Director Regulatory Affairs

      Relocation Assistance:  NoMust have United States Citizenship Oversee the Regulatory Affairs activities in the company’s enterprise and businesses including Dako.Develop the global organizational regulatory strategies, implement and monitor the regulatory strategies and activities.Evaluate current processes & procedures and implement new and necessary improvements and additions.Build-up of an ...

    5. DIRECTOR REGULATORY AFFAIRS

      Director Regulatory Affairs- Oversee the Regulatory Affairs activities in Agilent enterprise and Agilent businesses including Dako. - Develop the global organizational regulatory strategies, implement and monitor the regulatory strategies and activities. - Evaluate current processes & procedures and implement new and necessary improvements and additions. - Build up of an efficient ...

    6. Senior Clinical Research Associate CRA - Clinical Study Monitor 98202

      Job Description:A Senior Clinical Research Associate - CRA (Medical Affairs; Clinical Operations: HPV/Microbiology/Point of Care focus) is needed for a 6-month, renewable contract position at major biotech in Northern California.About Client:My client is a leader and innovator in healthcare diagnostics. They are consistently rewarded for their research, which provides patient’s with tailored, ...

    7. Clinical Research Associate - CRA - Clinical Study Monitor (98202-1)

      Job Description:A Clinical Research Associate - CRA (Medical and Scientific Affairs focused) is needed for a 6-month contract position at major biotech in Northern California.About Client:My client is a leader and innovator in healthcare diagnostics. They are consistently rewarded for their research, which provides patient’s with tailored, integrated solutions. It is a growing and stable ...

    8. Labeling and Technical Publication Specialist

      Hello,My name is Caitlin and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Labeling and Technical Publication Specialist for a Prominent client of ours. If you are interested, please send me a word document version of your resume, as the version I have may be out of date. Details for the positions are as follows:·         Will oversee teams ...

    9. Regulatory Affairs Director

      Kelly Services is currently recruiting for a Regulatory Affairs Director for our biotechnology client in Newark, CA. This is a direct-hire role with benefits!Regulatory Affairs Director Newark, CAThis position leads the execution, maintenance and monitoring of Regulatory submissions in compliance with approved procedures. This position recommends regulatory strategy and manages global ...

    10. Clinical Research Associate (CRA) - Clinical Study Monitor (97923)

      Job Description: A Clinical Research Associate (Clinical) is needed for a 6-month contract position at major biotech in Northern California. To liaise between various Medical and Scientific Affairs Department to manage resource, budget and timeline for studies To coordinate and execute clinical research activities for multisite clinical studies Support the post-launch evaluation of ...

    11. Medical Director & VP, Clinical Affairs

      Location: Mountain View, USA or Taipei, Taiwan Company Profile: CellMax is fundamentally and dramatically transforming early cancer detection and prevention. With its patent-pending, simple and accurate blood test, CellMax’s goal is to eventually screen every person in the world. The technology was developed by Scientists from Stanford at the Genomics Research Center at Academia Sinica, ...

    12. Clinical Trial Manager- Oncology

      We are looking to add a permanent Oncology Clinical Trial Manager to the team. The Clinical Trial Manager (CTM) is responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensures completion of study deliverables, typically works on studies with moderate to high complexity (in terms of design, location, phase, etc.), and ...

    13. Regulatory Affairs Associate

      Hello,   My name is Jonathan and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Regulatory Affairs Associate for a prominent client of ours.  This position is located in Santa Clara, CA. Details for the positions are as follows:   Job Description / Requirements Responsible for filing necessary applications and handling all government ...

      1. Modeler (Structural Engineering, Mathematical Modeling) at Risk Management Solutions (RMS)

        The Model Development group is looking for a Modeler to help it build industry leading stochastic catastrophe models for the quantification and management of

      2. Associate Director or Sr. Manager of Clinical Site Budget Negotiation at FibroGen, Inc.

        Broad knowledge of general pharmaceutical contract law, regulatory law and policies relevant to clinical contracts (healthcare compliance, GCP, CFR)....

      3. Manufacturing Buyer/Planner at AcelRx Pharmaceuticals, Inc.

        The ideal candidate will have at least 3 years’ experience working in a Purchasing & Planning role in a Life Sciences, Biotech, or Medical Device company....

      4. UI UX Architect at Digital Management, Inc.

        W o r k i n g a t D MI. Prov i d e accu r a t e t a s k b r eakdo w n an d e sti m a t e s. Bu il d and i m p r ove s o ft w a r e and t oo ls by tr an sl a ti...

      5. Member of the Technical Staff at Palantir Technologies

        Fluency in scientific programming (MATLAB, Python, R, SQL, etc.). Palantir is hiring mathematicians for a new team to solve some of the hardest problems the...