• Clinical Quality Assurance Manager

    Olympus Corporation of the Americas (Center Valley, PA)
    …The Clinical Quality Assurance Manager reports directly to the Executive Director of Clinical Quality Assurance and provides support to ensure the ... or contribute to the development and maintenance of key Clinical Quality metrics for input into process...+ Solid knowledge of ICH- GCP , applicable global clinical regulations and guidelines, and quality principals… more
    Olympus Corporation of the Americas (03/21/25)
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  • Senior Director , Regulatory Affairs…

    BeOne Medicines (Emeryville, CA)
    …12+ years' experience in positions of increasing responsibility in Regulatory Compliance and/or clinical ( GCP ) quality assurance + Experience leading complex ... involves leading and overseeing all aspects of regulatory and clinical quality event investigations, quality ...mentor individuals involved in the reporting and processing of quality events supporting GCP quality … more
    BeOne Medicines (05/09/25)
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  • Executive Director - Therapeutic Area…

    Regeneron Pharmaceuticals (Basking Ridge, NJ)
    …The Executive Director TA Operations Leader is responsible for directing clinical operations activities and decisions including quality , timelines and costs ... of clinical research studies in accordance with applicable regulations, ICH/ GCP regulations and company Standard Operating Procedures (SOP's) within assigned TA… more
    Regeneron Pharmaceuticals (05/22/25)
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  • Clinical Research Coordinator B/C

    University of Pennsylvania (Philadelphia, PA)
    …industry-sponsored clinical trials. The CRC will report directly to the Director of Clinical Research Operations and collaborate with Physician Investigators ... of clinical trials, ensuring compliance with institutional, FDA, and Good Clinical Practice ( GCP ) standards.The Department of Dermatology at the University… more
    University of Pennsylvania (05/04/25)
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  • Associate Director , CRA Functional Manager

    BeOne Medicines (Emeryville, CA)
    …with CTOMs; including but not limited to adherence to monitoring SOPs, GCP guidelines, country-specific regulations, and general quality and risk-based ... the performance and results of multiple related teams Supports SR Director to develops departmental plans, including business, production and/or organizational… more
    BeOne Medicines (05/27/25)
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  • Associate/ Director of Biostatistics, Early…

    IQVIA (Durham, NC)
    …as well as the International Conference on Harmonization (ICH) and Good Clinical Practice ( GCP ) procedures. + Collaboratively develops and conducts ... **Job Level: Associate/ Director of Biostatistics,** **Early Phase Pharmacodynamics** **Location:** **Home-based...as the International Conference on Harmonization (ICH) and Good Clinical Practice ( GCP ) procedures. + Good understanding… more
    IQVIA (04/01/25)
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  • Senior Director , R&D Strategic Sourcing

    Otsuka America Pharmaceutical Inc. (Princeton, NJ)
    …Strategic R&D Sourcing strives to maximize contract value while maintaining strict quality standards. The Senior Director role is responsible for setting ... actuals vs. forecasts in collaboration with Finance and key functional partners ( Clinical Management, Regulatory Affairs, Global Quality , Data Management, Global… more
    Otsuka America Pharmaceutical Inc. (05/16/25)
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  • Senior Medical Director…

    IQVIA (Durham, NC)
    …Officer, Medical Directors, medical writers, and safety associates. The Senior Medical Director provides medical and scientific support to clinical research ... the project teams. The primary role of Senior Medical Director is to provide medical oversight for clinical...and reporting . Ensures medical activities run according to GCP and operate with highest efficiency . Establishes and… more
    IQVIA (05/09/25)
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  • Global Medical Director , Evidence…

    Sanofi Group (Morristown, NJ)
    …that leverage digital tools & technologies for advanced medical and clinical research opportunities. **Compliance and Quality Assurance** + Accountable ... **Job title** : Global Medical Director , Evidence Generation - Insights and Strategy **Location:**...all evidence generation activities comply with regulatory requirements, Good Clinical Practice ( GCP ), and company policies. +… more
    Sanofi Group (05/02/25)
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  • Global Medical Director , Evidence…

    Sanofi Group (Cambridge, MA)
    …for ensuring all evidence generation activities comply with regulatory requirements, Good Clinical Practice ( GCP ), and company policies. + In charge of ... **Job title** : Global Medical Director , Evidence Generation - Innovation & Partnerships **Location:**...in patient and scientific knowledge and insights to improve clinical care. We do this by generating and curating… more
    Sanofi Group (04/23/25)
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