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regulatory affairs in San Francisco Bay Area

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  1. Medical Director at Ascend Clinical

    Medical Director Why Ascend Genomics? Ascend Genomics is a CLIA-certified, CAP-accredited full-service reference laboratory that specializes in DNA-based

  2. Director, Clinical Operations at Global Blood Therapeutics, Inc. (GBT)

    RN/PA with professional clinical experience, and/or master’s degree or higher in health-related science or equivalent preferred. Director, Clinical Operations....

  3. Licensed Clinical Social Worker (Psych Emergency Dept) at Marin General Hospital

    D. Documents all collateral contracts. D. Maintains positive working relationships with community agencies. D. Participates in Quality Improvement activities...

  4. Licensed Clinical Social Worker or Clinical Social Worker (MSW) (Sign On Bonus) at Marin General Hospital

    D. Documents all collateral contracts. D. Maintains positive working relationships with community agencies. D. Participates in Quality Improvement activities...

  5. Assoc. Dir/Director, Strain Development/Fermentation Process Development at Amunix

    Experience preparing successful CMC sections of regulatory submissions (IND/CTA’s) and interacting with FDA/EMA and other foreign regulatory authorities...

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    1. Regulatory Affairs Specialist (Complaint Handling)

      Hello, My name is Chrys and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Regulatory Affairs Specialist for a prominent client of ours. This position is located in Mountain View, CA Details for the position are as follows: Job Description:Effectively implements the complaint handling process and processes complaints in a uniform and timely ...

    1. Data Scientist at CGG

      Knowledge of Perl, R, and Spark. Master's degree (or higher) in Computer Science, Math, Statistics, Physics or a closely related field is preferred (Ph.D....

    1. Senior Clinical Trials Manager

       Senior Clinical Trial Manager - South San Francisco, CA Position Summary:The Senior Clinical Trial Manager is a critical position within the clinical team. In close collaboration with the VP Clinical Operations & Regulatory Affairs, the Sr. CTM will be responsible for the operational management of company’s clinical trials.The Sr. CTM will partner with company’s Medical Monitor and other ...

    1. Principal Scientist, Computational Biology (Position may be located in San Diego, CA or San Francisco, CA, or Cambridge, MA or Seattle, WA) at Celgene

      Strong interest in the inter-disciplinary application of computational analysis methods to life sciences data is imperative, as is rich background and...

    1. Director, Clinical Operations (440087)

      OVERVIEW:The Director, Clinical Operations develops and implements strategic direction in the conduct of multiple clinical studies. Accountabilities include providing oversight to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements, and leading and directing ...

    1. Data Scientist Predictive Analytics at Axius Technologies

      In Computer Science, Engineering Disciplines, Mathematics, Statistics with computer programming skills, Algorithm design. Data Scientist Predictive Modelling....

    1. Senior Clinical Project Manager (439611)

       OVERVIEW:This position will work with the clinical team to manage execution of clinical studies for Client's various products. The position will either focus on complex Phase 1 studies or global Phase 3 studies. Depending on project complexity and level of experience, this may include managing one or more clinical studies and/or managing a multi-national region for multiple global clinical ...

    1. Principal Scientist, Computational Biology (Position may be located in San Diego, CA or San Francisco, CA, or Cambridge, MA or Seattle, WA) at Celgene Corporation

      Strong interest in the inter-disciplinary application of computational analysis methods to life sciences data is imperative, as is rich background and...

    1. Clinical Affairs Manager

       Job DescriptionThe Clinical Affairs position will assist the Clinical Affairs Director in planning, coordinating and completing studies. The candidate needs to have excellent communication and presentation skills, together with the ability to organize and motivate others. The candidate must demonstrate enthusiasm, innovation and leadership when faced with challenges and will provide ...

    1. Data Scientist Risk Analytics at Signifyd

      Expert proficiency with an advanced data analysis toolkit (such as python/matplotlib, R, ROOT, etc.). Or Ph.D) in computer science, applied mathematics, or a...

    1. Regulatory Affairs Director / Clinical Design Manager  Clinical Trials

      Too frequently, physicians exhaust all available treatment options for cancer patients. However, every cancer tumor contains unique genomic changes that can be targeted to attack the tumor. Our Client had developed sequencing which unlocks the genomic information physicians need to optimize treatment providing DNA-based cancer testing technology. The Regulatory Affairs professional will be ...

    1. Construction Estimator at Currie & Brown Inc.

      5-10 year plus experience including a substantial track record of working on engineering and construction projects in pharmaceutical, life sciences, biotech or...

    1. 2 Regulatory Affairs Associate-PMA Annual reports-

      Regulatory Affairs Associate –SANTA CLARA CA59585 40-45.00 AN HOUR W2 CONTRACT 6 MONTHS+Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of ...

    1. Territory Sales Representative at Ingenium

      5+ years Haz Waste, BioTech or Pharma Sales experience*. $50,000 - $85,000 DOE + commission*....

    1. Senior Clinical and Medical Affairs Manager

      Senior Clinical and Medical Affairs Manager - 1106Redwood City, CAThe Senior Clinical and Medical Affairs Manager leads the processes for medical and clinical operations and project management for the organization. The Senior Manager works cross-functionally with internal and external stakeholders to ensure clinical and medical projects (such as investigator-initiated trials, company ...

    1. Scientist - ELISA Method Development at The Richmond Group USA

      Join a company with over 30 years of experience and reduce the stress that comes with the natural instability of the biotech world....

    1. Senior Clinical Data Manager (439728)

       Overview:The Senior Clinical Data Manager (SCDM) will be responsible for study data collection and management for all Client's studies. The SCDM will be an integral member of the Clinical Operations team and the extended Medical Affairs Team. In collaboration with the programming team, they will implement and manage data collection and data transfers for biomarker and clinical data with an ...

    1. Scientist (Application) at GenapSys

      At GenapSys we are working to change the world of healthcare and diagnostics. Our team brings together an incredibly diverse and multidisciplinary set of

    1. Regulatory Affairs - All Levels

      Top 3 Skills: · 1+ years of experience in regulatory affairs, or biotech industry· Manufacture, testing (QC/QA or clinical), or distribution in Biotech/Pharma industry· Excellent communication (both written and verbal), presentation and facilitation skillJob Description:Support Chemistry Manufacturing and Control Regulatory staff performing product development and lifecycle management. ...

    1. Field Application Scientist (FAS) - West Coast at Thermo Fisher Scientific

      M.S./BSc or above in biotech or life sciences. Understanding of cGMP regulatory environment. Facilitate efficient communication between Commercial team and...

    1. Senior Scientist, Clinical Research

      About Aquinox:Aquinox is a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Our primary focus is anti-inflammatory product candidates targeting SH2-containing inositol-5'-phosphatase 1, or SHIP1, which is a key regulator of an important cellular signaling pathway in immune cells, known as the PI3K ...

    2. Quality Assurance Manager

      Summary:  Join a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics.  The QA Manager will independently perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements for parenteral drug products. Specific responsibilities include, but are not limited to:Writing and/or implementing ...

    3. Manager - Quality Assurance and Regulatory Affairs

      NeilMed Pharmaceuticals, Inc. is an ISO certified manufacturer of Class I medical devices. Our products are registered with the FDA and manufactured at our Corporate Headquarters in Santa Rosa, California.  Due to expansion, we are looking for an additional Quality Assurance & Regulatory Affairs Manager to add to our quality team. The position is responsible for the development and ...

    4. Regulatory Affairs Associate (439033)

      OVERVIEW: Reporting to the Manager/Senior Manager, Regulatory Affairs, Chemistry Manufacturing and Controls (CMC), you’ll be responsible for:Coordinating the planning, preparation and submission of global regulatory CMC-related submissions, including post approval variations, Marketing Application(s) and Annual ReportsDeveloping and/or reviewing regulatory documents to ensure that all ...

    5. Regulatory Affairs CMC Associate (439033)

      OVERVIEW:Reporting to the Manager/Senior Manager, Regulatory Affairs, CMC, you’ll be responsible for:- Coordinating the planning, preparation and submission of global regulatory CMC-related submissions, including post approval variations, Marketing Application(s) and Annual Reports- Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet ...

    6. Regulatory Affairs Associate II / Senior (439032)

      OVERVIEW:The Associate, Regulatory Affairs will be assisting the regulatory team in supporting clinical and/or nonclinical studies.RESPONSIBILITIES:Coordinate the preparation and submission of domestic and international regulatory submissions related to clinical and nonclinical aspects of product development, including the following:•   INDs or international equivalents and amendments•   NDAs ...

    7. Regulatory Affairs Associate (439031)

      OVERVIEW:The Associate, Regulatory Affairs will be assisting the regulatory team in supporting clinical and/or nonclinical studies.RESPONSIBILITIES:Coordinate the preparation and submission of domestic and international regulatory submissions related to clinical and nonclinical aspects of 0product development, including the following:   o INDs or international equivalents and amendments   o ...

    8. Clinical Supplies Manager (438917)

      OVERVIEW:The Clinical Supplies Manager is the primary point of contact to internal and external customers for Clinical Development projects.  Represents the Clinical Supplies team on various project related teams and manages all activities as they relate to clinical drug supply.Position Requirements:ESSENTIAL DUTIES AND RESPONSIBILITIES:• Management of packaging, labeling, storage, and ...

    9. Clinical Data Manager, Bio- Oncology (438874)

      OVERVIEW:Clinical Data Management (CDM) resides within the Data Management and Programming Function in the Department of Biometrics, Health Outcomes and Payer Support (BHOPS) in US Medical Affairs (gMed).Members of the CDM group are allocated to work in one of three Disease Biology Areas (Bio-Oncology, Autoimmune/Ophthalmology/Asthma and Virology/Specialized Products) and report to the Head ...

      1. Sales Manager, Spectroscopic Devices, Photonics, lasers and Instruments at BaySpec, Inc.

        Candidates who have current and past experience in serving the analytical instrumentation, chemical engineering, semiconductors, biomedical, biotech,...

      2. Senior Clinical Trial Manager at Global Blood Therapeutics, Inc. (GBT)

        Liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) in order to accurately coordinate clinical...

      3. Senior Market Planning Manager – Pharma/Biotech W2 ONLY at Consultant Specialists, Inc. (CSI)

        Advanced degree in science required (Master or PHD). 5703746 Senior Market Planning Manager – Pharma/Biotech W2 ONLY 3 Month Contract....

      4. Experienced* HVAC/Refrigeration/Foodservice Equipment Techs at Commercial Appliance Service Inc.

        D ) service technician, we want to hear from you no matter where you live in the Bay Area! \*\*\*RESUMES WITHOUT EXPERIENCE WILL NOT BE CONSIDERED\*\*\**....

      5. Scientific Data/Software Specialist, Spotfire, Excel, SQL at UCB, Inc.

        SQL, Spotfire, Google Apps suites in biotech field:. Solid knowledge of biological science, drug development, and the project management process....