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Work in close collaboration with colleagues in R&D Quality Management, operational units in Drug Development (Clinical Development, Clinical Operations, Data Management, Manufacturing, Medical Affairs, Laboratories, Pharmacovigilance, Regulatory Affairs, Translational Medicine, vendors (CSPs) and partners in GMP QA.
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Work closely with Regulatory Affairs, Analytical Development, API Process Development, Drug Product Process Development, and External Stakeholders to communicate document-specific timelines to team members to ensure timely deliverables.
$104,000 - $166,750 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Safety Statisticians are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety and Epidemiology (e.g., product safety team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing.
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This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as unprecedented new drug modality.
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Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
$103,500 - $170,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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The Manager-Publications is expected to develop and utilize a network of internal relationships with local and global publication stakeholders, including colleagues from Medical Affairs, Clinical Data Science & Evidence, legal, regulatory affairs, global publication team, and commercial publications colleagues from market access and marketing.
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The Scientific Affairs Manager will also liaise with cross-functional team members including clinical, regulatory, quality, legal, supply chain and will be responsible for managing individual study budgets/milestone payments.
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The Scientific Affairs Manager will also support abstract, poster and manuscript tracking and review for ISS studies and may occasionally support similar study management processes for Collaborative studies.
$109,300 - $218,700 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Managers of Statistical programming provide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products.
$158,496 - $173,326 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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As a Legal Department Intern, you will work closely with the Legal team supporting business functions which may include Marketing, Sales, Medical Affairs, Market Access, Digital, HR, IT, Public Affairs, Finance, Market Access, Sales Operations, Supply Chain Management and Operations, Quality and Regulatory.
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Associate Director , Statistical Programming , provide s functional expertise and leadership to clinical project teams to lead statistical programming teams and support the development, regulatory approval and market acceptance of Bristol Myers Squibb products.
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As part of the US Medical Affairs team, the Medical Science Liaison (MSL) will be responsible for engaging identified key opinion leaders (KOLs) from institutions and organizations within the assigned geographical territory through high level scientific support for research activities, publications, education, consulting, and other Medical Affairs initiatives.
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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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License to practice Speech Language Pathology issued by PA Bureau of Professional and Occupational Affairs is preferred. Will consider strong Clinical Fellowship Year (CFY) candidate for Long Term Substitute (LTS) positions in the Related Services program.
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Works in close alignment with all Therapeutic Area Leads (TAL), MSL Heads, RWE Lead, Sr Director of NS Franchise, Strategy/Insights/Analytics Lead, Directors of Marketing (DOM) and other cross-functional Key Stakeholders (KSH) within NS Global MAF, Regulatory, JSA (Scientific Affairs) and R&D.
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regulatory affairs jobs Title: regulatory project manager Company: Gpac in Lawrence, NJ
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