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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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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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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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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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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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Janssen Scientific Affairs, LLC, a Johnson and Johnson Company, is recruiting for a Principal Scientific Account Lead, Value and Evidence Scientific Engagement - Field Based to support Primary Territory: North Florida/South Carolina.
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Assist the Clinical Program Director, Program Supervisor and Lead Housing Specialist in communicating with the Department of Community Affairs and HUD with Project Managers for COC vouchers for chronically homeless individuals in Mercer County.
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Under the supervision of the Head of Government Affairs, help to support U.S. CEO in his role as PhRMA Board Member. - Provide expertise to Government Affairs Public Policy team to identify mitigations and opportunities to shape legislation, proposed rules, and draft guidance.
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Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer’s guides, etc.
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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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Project management Manager will consider candidates who come from medical writing and communication agencies, pharmaceutical and biotech companies, Regulatory affairs writing, medical information, product safety, medical affairs.
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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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Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas. Board Certified in therapeutic area and US fellowship training, or MD with 2-4 years' experience in within the pharmaceutical industry including 2 years in-house Medical Affairs role, or PhD or PharmD with 5 years' experience within the pharmaceutical industry, including experience in the therapeutic area and 3 years in an in-house Medical Affairs role; MD preferred.
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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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affairs job Title: regulatory project manager Company: Gpac in Lawrence, NJ
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