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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
$286,700 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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In conjunction with the AVP, Medical Affairs NA - Biologics and Market Access, will be the responsible member of the Sun Pharma medical department in regulatory interactions, ISS and expert advisory board meetings, external professional societies, seminars, and conventions.
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Associate Director, Medical Affairs Cell Therapy, Franchise Strategy And Operations, Project Manager
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The Associate Director, Strategy and Operations is responsible for partnering with colleagues in Medical Affairs and in other functions including Commercial, both Heme and Cell Therapy to lead or support Strategic Planning responsibilities.
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
Full-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
$237,500 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Professional and/or academic background in one or more of the following: Diversity, Equity, Inclusion, and Belonging; Student Affairs; International Education or Study Abroad; Psychology or Counseling; Conflict Resolution and Mediation; Crisis Response and Support; Social Science (data collection and analysis.
Full-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Advise the Vice Provost for International Affairs and other University leaders on emerging and/or urgent threats and risks to University interests stemming from geopolitical or other safety and security developments in the United States and abroad.
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Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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The Senior Scientist supports the Center for Outcomes Research, Real-world Evidence and Epidemiology (CORE) team in Global Medical Affairs. Engage with cross-functional teams in medical affairs strategy, commercial, market access, safety, legal.
ExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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From July 2000 until August 2001 Gordon was Vice President of Academic Affairs and Interim Dean at Teachers College, Columbia University. Professor Gordons distinguished career spans professional practice, scholarly life as a minister, clinical and counseling psychologist, research scientist, author, editor, and professor.
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Collaborate closely with other key functions, including regional medical leads, clinical development, global value and real-world evidence, US and global commercial teams, market access, and regulatory affairs, to ensure integrated global strategies and cohesive medical affairs strategies and input into cross functional leadership meetings and plans.
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Knowledge of internal disciplines such as clinical operations, data management, Pharmacovigilance Operations, Medical Writing and Regulatory Affairs is a plus. 4 plus (4+) years of R&D (Clinical Studies, CROs, Central Lab, IRT, IRBs, Wearables, Investigators sites, Medical Affairs, HEOR, CMC and other related ancillary providers etc.
$207,000 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The base salary range for the Associate Director, Global RWE (Real World Evidence), Global Medical Affairs - Neurology is from :181,000-237,600. This role primarily focuses on late-stage pipeline and marketed products, interfaces with cross-functional teams including US medical affairs, marketing, market access global value and access teams, commercial to align strategies in customer research activities and development of external communication materials.
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Work with CMC cross-functional teams and Regulatory Affairs teams. Regulatory & Medical Affairs - Regulatory Studio - CMC Senior Manager. BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred.
ExpandApply NowActive JobUpdated 29 days ago
affairs job Title: regulatory associate in Skillman, NJ
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