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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Overview The (OEA) at Tufts University School of Medicine is primarily responsible for the medical school academic programs, curriculum design and delivery, system-wide evaluation, faculty development, interaction with the offices of Student Affairs, Registrar, and Professional Degree Programs, and promotion of academic excellence through grant participation for innovative programs.
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Act as the technical writing expert for CMC regulatory submission documents in cross-functional project teams and as a deputy to the Director, Regulatory Affairs CMC in various internal and external meetings – representing Regulatory CMC as needed.
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Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package (e.g. briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions (e.g. with FDA CDRH, EU notified bodies.
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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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Strong knowledge of and/or experience with government programs regulatory, operational, financial, and clinical requirements for the delivery of health insurance and managed care products and services, including Medicare, Medicaid, MMP, LTSS, SNP, Duals, CHIP, and behavioral health, as well as the associated and relevant federal, state, and local regulatory entities.
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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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Must be and remain compliant with any and all regulatory requirements for working in the cannabis industry. The Dispensary Associate is responsible for guiding customers through the cannabis purchasing experience, making informed recommendations based on customer's desired outcomes, provide informed and accurate descriptions of our products, and operate with a high level of accuracy in a fast-paced environment.
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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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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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Experience in patient advocacy, market access, government affairs/relations, public health policy, campaign work, or coalition building. Significant knowledge and appreciation of the complexities of the drug development process and regulatory requirements.
$258,000 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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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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Participate in a Multidisciplinary Peer Review and Trauma Executive Committees at the referral centers and at BWH.Maintain knowledge of the external regulatory agency (American College of Surgeon and Department of Public Health Commonwealth of Massachusetts) requirements for verification and designation of trauma centers.
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The candidate who assumes this role will lead a team of compliance professionals supporting execution of the Bank compliance management program, including risk assessments, compliance policies and procedures, training, issues management, complaint administration, regulatory filings, third party risk management and the Community Reinvestment Act (CRA.
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regulatory affairs jobs Title: monitor in Boston, NH, Virginia
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