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Knowledge of Occupational Health, Worker’ Compensation System, OSHA, infectious diseases, wellness and regulatory compliance programs. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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This role involves collaboration with various departments, including operations, procurement, legal, research and development, regulatory affairs, and quality assurance to ensure that contracts align with business objectives, comply with relevant regulations, and mitigate risks.
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Work closely with other departments, including Commercial, Medical Affairs, Regulatory, and Legal, to align market access strategies with broader business objectives. Experience in public policy, or government affairs within the pharmaceutical or biotechnology industry, with a strong focus on rare diseases is highly preferred.
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Collaborate with Clinical Development, Regulatory Affairs, and other key departments to promote a robust drug safety culture. Lead and author key pharmacovigilance documents, including medical safety assessments and regulatory responses, applying regulatory guidance for safety surveillance and document authorship.
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8+ years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development; both big and small company experience is preferred.
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Proclinical is seeking a Director, Regulatory Affairs for a mid-sized oncology focused biotechnology company with their site in Massachusetts. Report to our Head of Regulatory Affairs and work side by side with your R&D colleagues to develop and execute innovative regulatory strategies for their development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Series 07 - FINRA, Series 24 - FINRA.
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Lead a team to ensure timely assay development, regulatory-compliant qualification or validation of assays, and troubleshooting of any internal or external CRO partner issues. Strong understanding of GLP requirements and current industry trends and regulatory expectations associated with bioanalytical science.
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III. PRINCIPAL DUTIESWork in collaboration with the Dean for Clinical and Academic Affairs and Office for Clinical and Academic Affairs to identify and prioritize strategies to promote gender equity and career development, satisfaction, and fulfillment for HMS basic and social sciences faculty.
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Supports the University of Massachusetts Boston Police Department mission and the policies and procedures in support of that mission, which is aligned with the University and the Division of Student Affairs' mission.
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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Emerson College, a premier global arts and communication institution with a foundation in the liberal arts, invites inquiries, nominations, and applications for its next Vice President for Student Affairs (VPSA.
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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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Under the general direction of the MassHealth Chief Medical Officer, or designee, the Program Manager for MassHealth Health Equity Programs works directly with MassHealth Program and Office of Clinical Affairs leadership to manage health equity measurement and value-based care initiatives for MassHealth programs.
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Skills and Qualifications Doctorate degree & 2 years of MSL/Medical Affairs experience; Master's degree & 3 years of MSL/Medical Affairs experience Pharm. Identify and facilitate opportunities for data generation activities through proposals for posthoc analyses, Investigator-Initiated Trial (IIT), and Medical Affairs-sponsored studies for research that is aligned with Galderma's strategic focus in a compliant and collaborative manner with home office colleagues.
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regulatory affairs jobs Title: principal in Dorchester Center, MA
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