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Experience in providing statistical programming support to early and late phase clinical trials, and regulatory submissions (NDA, MAA). Associate Director, Statistical Programmer page is loaded.
$164,000 - $205,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Lead the cross functional study team for the EDODM1 Phase 1 study, including clinical monitors, data management, biostatistics, medical writing, safety, regulatory affairs, and pharmaceutical science and QA team members, both internally and externally.
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These activities will be performed in cross-functional collaboration with a range of partners throughout the organization, including the US Market Access, US Medical Affairs, Medical Outcomes Science Liaison (MOSL), Public Policy & Government Relations, and US Regulatory Affairs teams.
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Associate Regulatory Affairs Specialist. Senior Regulatory Affairs Specialist. Regulatory Affairs Specialist. Cybersecurity Policy Program Director - Global Regulatory Affairs, Strategy, and Policy.
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This position will collaborate with other members of CMC, Quality Assurance, Regulatory Affairs, Commercial, and Finance teams to enable launch readiness, ongoing commercial supply, and lifecycle management of our late-stage and commercial programs.
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Collaborates with Regulatory Affairs, Clinical Development, Biostatistics, Real World Evidence Center of Excellence, Global Medical Affairs, Health Economics and Outcomes Research and Clinical Operations.
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0-3 years of experience in life science (pharmaceutical, biology, chemistry, bioinformatics) or engineering industry with a focus on information technology, clinical research, quality, regulatory affairs, manufacturing, or supply chain.
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Collaborate with multiple functional groups across the organization, including but not limited to Field, Regulatory, Market Access, Market Research, Commercial Operations, Legal, Patient Advocacy, and Medical Affairs.
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Collaborates closely with cross-functional teams, including process chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs, to develop and implement effective process engineering strategies.
$160,000 - $205,000 a yearFull-timeExpandUpdated Today - UpvoteDownvoteShare Job
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Develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. They are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product.
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The HEOR : RWE Associate Director will serve as an internal resource to support and lead RWE programs within cross functional teams, including HEOR scientists, Clinical Development, Medical Affairs, Market Access, Brand Marketing, Patient Advocacy, Business Development, Legal, and Regulatory to align evidence generation efforts with identified evidence gaps.
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About the RoleThe Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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You may also assist in the development of new regulations, as well as the review of the environmental and cost impacts of proposed activities, legislation, and policies before the State legislature, Executive Office of Energy and Environmental Affairs (“EEA”), and the DPU; and make recommendations to the DPU regarding its involvement and intervention.
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Initiate and lead the development of a cross-portfolio external engagement strategy and related tactics for prioritized external organizations and HCPs, aligned across Global Medical Affairs Oncology, Commercial, Patient Value, Policy & Access, R&D, Corporate Communications & Advocacy, Health Equity, and Patient Affairs, and with other key cross-functional/ex-Oncology partners as needed to ensure a one-company approach to external engagement strategy, objectives, and execution.
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Under the direction of the Senior Director, Radiation Sciences and Molecular Imaging, the Associate Director/Director, Radiation Sciences and Molecular Imaging will work collaboratively with internal team members of the Radiation Sciences team as well as work cross functionally with other divisions within Fusion, including but not limited to Clinical Operations, Non and Per- Clinical teams, Pharmacometrics, DMPK and Regulatory affairs.
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regulatory affairs associate jobs in Boston, MA
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