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Ensure strong relationships with key stakeholder functions including Analytical Development, Cell Culture, Purification, Research, Clinical Operation, and Program Strategy Teams by providing technical and strategic input.
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The Associate Director, Clinical Records & Information Management will partner with cross functional teams as well as Clinical Research Organization (CRO and Functional Service Provider (FSP) to ensure timely and quality delivery of the TMF. This role is a member of the Clinical Records leadership team to ensure optimum implementation of the TMF technical capabilities and oversight of standardization, training, quality, and timely clinical trial documentation across the clinical program.
$191,335 - $247,610 a yearExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Significant experience working in drug safety / PV or a related field in the biopharma industry, clinical research, health administration, health policy, epidemiology, or academic or subspeciality medicine.
$274,635 - $355,410Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Doctoral degree (e.g. PhD, MD, ScD, PharmD) and/or Master’s degree (e.g. MSc, MPH) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a minimum of 8 years (PhD) or 10 years (MS) of relevant experience.
$201,025 - $260,150 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Conduct policy research and analyze relevant reports, peer-reviewed journal articles, and legislative/regulatory proposals pertaining to Virology policy. Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need.
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. BA or BS and 12+ years' experience in compliance and trial master file in pharmaceutical/biotechnology industry.
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Extensive knowledge and understanding of FDA, EMEA, ICH, GCPs governing the maintenance of clinical TMF. Document Records Management experience using electronic TMF platforms. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
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RequirementsDoctoral degree (e.g. PhD, MD, ScD, PharmD) and/or Master’s degree (e.g. MSc) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a minimum of twelve (12) years of relevant, post-graduation experience; preference for a minimum of six (6) years of that experience to be in the biopharmaceutical industry.
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Conduct policy research and analyze relevant reports, peer-reviewed journal articles, and. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
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