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Provide medical input and guidance to development and study/project teams and work collaboratively with cross-functional team members, such Data Management, Medical Directors and Clinical Scientists, Medical Safety and Pharmacovigilance and Medical Affairs to coordinate real time availability of clinical trial data, assuring data integrity, including safety, efficacy, pharmacokinetic, and correlative studies data to provide consolidated information for trial progress.
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Provides administrative support for the Associate Dean for Academic Affairs & Director of Clinical Affiliations. Provide support to Associate Dean for Academic Affairs and Director of Clinical Affiliations, as directed.
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Our department works closely with Analytical Development, Operations, Regulatory Affairs, and Quality control to formulate and manufacture innovative ocular formulations. Highly skilled in characterization techniques such as PLM, SEM, PXRD, TGA, DSC, DVS, FTIR, Raman, and UV/Vis.
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Those interested in the role should address a letter of interest and CV to:Dr. Paul Alfille, MGH Anesthesia Vice Chair for Clinical Affairs Dr. Doug Shook, BWH Anesthesiology Deputy Chair )with cc to: Danielle Le Hals, MGB Enterprise Vice President of Anesthesiology class="blockpanel">.
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Serving as a field-based extension of Medical Affairs, the Medical Science Liaison (MSL) will represent the Company, a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies that target p53 mutations.
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This position requires working with a wide variety of clients from local manufacturers to Federal agencies, including the U.S. Department of Veteran Affairs, U.S. Army Corps of Engineers, and others.
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The role actively supports corporate growth and revenue initiatives by directly collaborating with Scientific Affairs and Business Development personnel and participates in client interactions as needed.
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Bachelor's Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field. The Associate Director, Regulatory CMC executes multi-product global regulatory CMC strategies for cell therapy combination investigational and marketed products.
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The Associate Director is accountable for aligning pre- and post-launch plans with internal constituents in Medical Affairs, Commercial, and Clinical Development Teams. Leading planning, prioritization, and execution in alignment with internal stakeholders (US Medical Affairs, Commercial, Clinical Development) to ensure adequate resources for Medical Review for product launches.
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Work collaboratively with stakeholders including but not limited to Market Access, Public Affairs, Commercial Legal, US Sales & Marketing, Global Pricing & Market Access, FP&A, Commercial Sales Operations, Accounting, etc.
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As an integral member of the team that will be tasked with product development, the Associate Director Regulatory Affairs will also serve as a subject matter expert (SME) for assigned development programs, which may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements.
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We are seeking a highly skilled, and experienced AD/Director of Regulatory Operations & Affairs to join our growing clinical team. Bachelor's degree in life sciences, pharmacy, or a related field with a minimum of 7-10 years of experience in oncology regulatory affairs within the biopharmaceutical industry.
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Ensure seamless coordination towards the drafting and advancement of effective federal legislation and regulations from BCBSMA to Congress and relevant federal agencies and ensure the coordinated flow of relevant legislative and regulatory information to the Vice President, State and Federal Government and Regulatory Affairs, and senior leaders including the Senior Vice President.
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Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs and Clinical Operations.
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This role reports into the SVP, Global Regulatory Affairs and GCP/GLP QA. Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities.
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affairs job in Watertown, MA
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