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This role is part of a global cross-functional team and interacts with Global Clinical Development, Clinical Management, Regulatory Affairs, Biostatistics, Global Medical Affairs, Commercial, Market Access, Government Affairs, and other colleagues to stay abreast of clinical development program needs for value differentiation in alignment with the target product profile across the product lifecycle.
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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.
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The Director, Corporate Counsel – Rare Disease will serve as the legal advisor to the US Commercial, Patient Advocacy, Public Affairs, Regulatory, and Medical Affairs teams supporting our Rare Disease Franchise, and will coordinate legal services with the attorney responsible for Canadian support for the Rare Disease Franchise.
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Strong business acumen and ability to see the business drivers outside of Regulatory Affairs. Hands-on experience in preparing regulatory submissions during development and for marketing authorizations.
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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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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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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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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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Develop and implement strategic MSL field/territory plans and objectives in alignment with Medical Affairs and product strategy and oversee the successful execution of these plans. Connect with appropriate internal stakeholders to ensure strategic and tactical alignment of the MSL team both within the wider Medical Affairs organization and with other Company departments.
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S/he will work cross-functionally with other leaders and functions (including all Medical Affairs functions, Commercial, Compliance, IT, Finance, Clinical Development and Legal) to drive from inception to completion all Rare Disease MA workstreams and projects and to provide relevant medical input on the strategic and tactical support for DAYBUE (trofinetide) in the US and in OUS markets.
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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.) Senior Manager, Outsourcing and Vendor Management, supports and implements strategic procurement activities for Taiho Oncology Inc. (TOI) and other TOI affiliates.
$159,800 - $188,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Internally interact extensively with colleagues from various departments and affiliates, including Medical Affairs, Corporate Sustainability & Social Impact (CSSI), Alliance Development, Sales & Marketing, Procurement, IT, Compliance and Legal.
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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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Advises project teams and collaborates cross-functionally with clinical, preclinical, pharmaceutical development, commercial and external resources on Regulatory Affairs issues to promote global acceptability of programs.
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This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs, CMC, New Products, Sales & Marketing, and Legal. The primary role of the Senior Manager, Business Development is to evaluate acquisition, in-licensing and out-licensing opportunities and make recommendations regarding the same.
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affairs job Title: regulatory affairs project manager in Princeton, NJ
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