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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.
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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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Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other medical affairs activities (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, continuing medical education.
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Collaborates closely with the US HEOR group on biologics-related activities (providing input into early economic models/endpoints, guiding trial design, assimilating HEOR input, and supporting data review for secondary publications), and presenting this back to the medical affairs teams.
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The Princeton School of Public and International Affairs at Princeton University may have an occasional need for lecturers to teach or co-teach in areas such as International Relations, International Development, Domestic Policy, Global Health, Psychology and Public Policy and Economics and Public Policy during the 2024 - 2025 academic year.
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Works with personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs. The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization.
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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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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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Executive Director Strategy and Business Operations Corporate Affairs. Lead and manage planning and logistics of internal and external l Global Corporate Affairs engagements (ex: JP Morgan Chase, global policy meetings, etc.
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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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Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs. Assists the Senior Medical Director in developing agenda for and executing national advisory boards, assists with defining strategies to support medical education programs and reviews IME grant proposals, represents Medical Affairs in Promotional Review Board (PRB) activities including reviewing medical and scientific content of promotional materials, maintains KOL relationships and serves as a consultant for Marketing, FMA, SCOE, Market Access, Public Affairs, and Sales.
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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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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.
$109,300 - $218,700 a yearFull-timeExpandApply NowActive JobUpdated 1 month 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.
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Collaborate with stakeholders in the real-world evidence community including Medical Affairs, Health Economic and Outcome Research, Epidemiology, Clinical and real-world evidence (“RWE”) analytics team members on real-world evidence generation to evaluate drug effectiveness and to generate disease insights.
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affairs job Title: regulatory affairs associate Company: Thermo Fisher Scientific in Princeton Junction, NJ
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