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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.
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Ability to work collaboratively with Regulatory Affairs, Medical Writing, and other functions to publish regulatory submissions and support management of documents and reports. Targeting 3 years of experience in Regulatory Affairs Operations or relevant function.
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Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs. This role may also lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings for a Therapeutic Area in certain instances, at the discretion of Executive Director of Medical Affairs.
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The Sr. Manager will provide input on regulatory CMC strategy and collaborate with key stakeholders to prepare regulatory submissions and Health Authority communications in alignment with the regulatory CMC strategy.
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In depth understanding of compliance and regulatory requirements for pharmaceutical Medical Affairs, R&D and Commercial work. Biotech / Pharmaceutical industry experience, with strong understanding of solid tumor drug development and medical affairs function.
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Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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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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Support project teams, regulatory affairs, product management, marketing, and product stewardship in topics related to toxicology and kinetics. The position is located in Princeton, NJ and is part of the global Regulatory Affairs Toxicology Group.
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Also, interacts routinely with colleagues across Market Access and Public Affairs, and internal stakeholders from Marketing, Medical Affairs, HEOR, Finance, Commercial, Field Sales, Government Pricing, and other relevant departments.
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Reporting to the Global Medical Affairs Strategy Lead (MASL) the Director will be responsible for the development and execution of the Global Medical Affairs strategic and tactical plans for the asset(s) for the primary indication as well as new indications to expand into as part of the asset life cycle management.
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Key ResponsibilitiesStrategy and Execution:Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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Work closely with regulatory affairs to provide operational oversight and support in the preparation and implementation of the regulatory strategic and operational plans to support efficient development and pathway to global registration.
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Engage, as directed, with internal stakeholders (e.g. multidisciplinary project groups) and external stakeholders (e.g. external experts and partners around emerging landscape; regulatory authorities.
$142,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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.) Ensures compliance with all regulatory and reporting requirements related to Supplier Diversity and tracks Supplier Diversity for RFI and RFP.
$159,800 - $188,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Must be able to effective articulate and negotiate complex project related matters to FDA. Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations.
$90,000 - $180,000 a yearFull-timeExpandApply NowActive JobUpdated Today
regulatory affairs jobs Title: regulatory affairs project manager in Princeton, NJ
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