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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.
$142,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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Ability to interact successfully with internal and external stakeholders including Clinical Development, Regulatory Affairs , Drug Safety and Pharmacovigilance, Legal , Commercial, Sales and Marketing, etc.
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Reports to the Integrated TA Strategy Lead. Collaborates closely with cross-functional teams, including sales, marketing, medical affairs, market access and policy/advocacy (MAPA), regulatory affairs, and other relevant NNI departments to ensure alignment of brand objectives, strategies, and marketing promotion.
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Communicate frequently with other Respiratory Sales Specialists across the country and cross-functional counterparts such as Marketing, Sales Ops, Market Access, Field Reimbursement, Training, and Medical Affairs to create alignment of business plan, focus on strategic drivers, and sharing best practices.
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Novo Nordisk’s Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions that drive patient access to innovative products.
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Utilizes software systems, including Medicat, PeopleSoft, a BASICS Feedback Survey tool, and Microsoft Outlook and Excel, to manage referrals to and from BASICS as well as scheduling and the online assessment students complete as part of BASICSCollaborates closely with colleagues across University Health Services and from across campus, including the Office of the Dean of Undergraduate Students and Graduate Student Affairs, to receive referrals and educate campus partners about BASICS.
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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 - UpvoteDownvoteShare Job
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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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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
$165,200 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Also, interacts routinely with colleagues across Market Access and Public Affairs, including franchise teams, and internal stakeholders from PCOR, Finance, Brands, HEOR, Government Pricing. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the people who need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes.
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Clinical Supply Chain (CSC) holds the responsibility of global clinical supplies of the Janssen Research & Development portfolio and the Global Medical Affairs portfolio. Janssen Research and Development, a member of Johnson and Johnson's Family of Companies, is recruiting for a a Senior Analyst End-to-End (E2E) Supply Planning to be located in Horsham, PA or Titusville, NJ. Remote work options may be considered on a case-by-case basis and if approved by the company.
$119,000 - $191,820 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Familiarity with Chemistry, Manufacturing, and Control (CMC), Pharmacovigilance and Quality, related aspects and their intersection with Regulatory Affairs. Location: Hybrid (2 days a week in Princeton, NJ office) The Executive Director, Head of Regulatory Affairs position will provide regulatory expertise and leadership to ensure that the company meets its objectives.
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The Medical Safety Specialist (Client) applies medical/clinical experience and product knowledge to multifunctional teams (i.e., Clinical, Quality, Risk Management, Complaint Management and Medical Affairs) to deliver product safety guidance to NPI and sustaining teams throughout the entire product lifecycle.
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In this role, you will lead the legal support, including directly advising, educating BMS colleagues, staying current on evolving global regulatory, legal and policy environment for BMS’ work with digital solutions, including regulated patient and physician-facing digital health solutions (e.g., digital medicine and digital therapeutics) such as mobile applications, diagnostic algorithms, digital biomarkers, use of artificial intelligence and clinical decision support solutions.
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affairs job Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in Lawrence, NJ
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