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Work collaboratively with the VP Medicare Compliance on strategic department planning including budget development, staff resource allocation and shaping the overall Regulatory Affairs Compliance infrastructure.
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Accountable for CMC regulatory affairs representation to specific CMC development Teams (e.g. TDT, CMC expert panel, specification committee), thus ensuring CMC regulatory strategy, scientific and procedural input required for advancement of the Vaccine development program assigned to their team.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
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The Associate Director, Clinical Pharmacology, will be responsible and accountable to lead and execute clinical pharmacology strategies and activities for assigned programs and studies from early through late-stage clinical development and approval, including post marketing activities, and collaborate cross-functional stakeholders including research, DMPK, translational medicine, clinical development, clinical operation, biometrics, regulatory, CMC, and project management.
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The DCAMM Director of External Affairs reports to the Chief of Staff and serves as an important member of the Executive Office team, helping DCAMM contribute to the Administration’s policy and goals related to decarbonization and housing, as well as access and opportunity for underrepresented populations, in addition to supporting the core mission of the agency in real estate, planning, design and construction.
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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The Associate Director of Regulatory Affairs will oversee daily regulatory affairs activities, including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements, and regulatory compliance to support the successful development, approval, and marketing of Marengo products.
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Close collaboration needed with multiple cross-functional Research and Development teams including Clinical Development, Regulatory, Medical Affairs, and Communications. Government Affairs: Implement policy requirements to achieve desired value proposition at the Federal and state levels including Congress, the White House, and other government agencies such as the Food and Drug Administration (FDA), Department of Health and Human Services (HHS), and the Centers for Medicare & Medicaid Services (CMS.
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Works with the Legislative Affairs Division assigned liaison to determine appropriate talking points, key issues important to members and ATF priorities and required to follow-up with the Office of Legislative Affairs post congressional visit to provide an after-action report to include items that need follow-up.
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In-depth knowledge of Regulatory Affairs strategies with an executive level of experience in the biotechnology and pharmaceutical industry with a focus on rare/ultra-rare disease and orphan drug development and the 505(b)2 pathway.
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Collaborate effectively with Clinical Development, Biometrics, Clinical Operations, Regulatory Affairs, Clinical/Translational Pharmacology, Pharmacovigilance, Quality, and external stakeholders as applicable.
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Practical experience in the pharmaceutical or biotech industry of at least five years in at least one major area of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs.
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Initiates and/or completes regulatory and other forms, such as MassHealth Long-Term Care and DMH/DDS PASSR forms and processes the completed forms with the appropriate agencies. ·Identify and refer to community services, as indicated·Accesses and navigates the EMR to obtain essential information and documents CMRS progress notes and Resource Specialist Quick Notes per department standards.
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Establish effective partnerships with cross-functional departments and leaders (e.g., regulatory affairs, CMC, Clinical Operations, and Product Development) to facilitate the identification and resolution of quality matters and other opportunities for quality process improvement.
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regulatory affairs jobs Title: regulatory affairs specialist in Cambridge, MA
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