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Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization. Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
$256,334 - $318,868 a yearFull-timeRemoteExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Author/review CSRs, publications, and regulatory submissions. + Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access, and value input into the development program(s.
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Working in conjunction with the medical affairs and clinical development teams, evaluate potential external clinical research collaboration opportunities and facilitate the conduct of external clinical investigator-initiated trials (IITs) and company-sponsored trials.
$185,013 - $207,311 a yearExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Reporting to the Senior Vice President, Global Regulatory Affairs, this key senior leadership role serves as a recognized regulatory policy leader and influential spokesperson in support of Amgen’s global regulatory initiatives.
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Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs.
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The Head of Regulatory Affairs Policy & Intelligence leads a team of remote professionals located in both the United States and Europe who are responsible for harnessing their diverse, broad, and industry-leading expertise to influence regulators on important issues in drug development and regulation that benefit Amgen’s business and the patients we serve.
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These stakeholders include colleagues in Health Economics and Outcomes Research, Operational Pricing, Advocacy, Health Policy, and Government Affairs and their respective Therapeutic Area heads for those functions represented on TAG (Research, Development, Regulatory, Medical, Operations, Marketing, and Project Management.
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Represents the Regulatory Affairs Therapeutic Area (TA) with Amgen executive leadership, governance bodies, regulatory agencies, and external partners. In this vital Vice President role, you will improve patient lives through leadership of the Regulatory Affairs for the therapeutic area of Obesity and Obesity Related Conditions (ORCs.
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