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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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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.
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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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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Collaborate with regulatory affairs to support regulatory submissions and inspections.
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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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The CCMO partners with Harvard Public Affairs and Communications and the HDS associate dean for development and external relations regarding media events, external relations, and campaign communications strategy and implementation.
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Primary Responsibilities:This role involves working closely with scientists and regulatory affairs departments on various nonclinical regulatory documents. The Scientific Editor's responsibilities will be:Collaborate with scientists on nonclinical regulatory documents such as Investigator Brochures, Nonclinical Study Reports, Annual Reports, CTAs, INDs, and NDAs. Assume lead scientific writing responsibility on projects, utilizing regulatory and publication documentation expertise.
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Through a comprehensive understanding of the diagnostic and care landscape, the candidate will closely collaborate with the International Business Unit (IBU) marketing and medical teams, Government Affairs, and International Communication teams to execute, in partnership with the local affiliate teams, integrated solutions designed to remove obstacles to optimal patient pathways.
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Lead and strengthen coordination and alignment of priorities and information sharing between OCPA and leadership and communications/marketing staff in Professional and Lifelong Learning (Executive Education & Public Leadership Credential), Degree Programs and Student Affairs, and Alumni Relations and Resource Development.
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Clinical validation: Work with Clinical Affairs to support validation of the RPM value proposition and build clinical evidence to support the regulatory strategy. + Regulatory approvals: Work with Regulatory to obtain and/or maintain regional regulatory approvals aligned with country launch roadmaps, including FDA clearance in the US and CE mark in Europe.
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Partner and collaborate with others including Director, Office of Academic Affairs on existing programs and initiatives (and develop and implement new programs) that align with the Broad’s commitment to engaging learners and trainees from groups historically underrepresented in biomedical science.
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This role will report to the Senior Vice President, Global Value, Access, Public Policy and Government Affairs. This role is responsible for leading the HEOR development and execution of the global evidence teams, engaging closely with and guiding the product development teams across our pipeline, supporting our regions and affiliates, as well as leading our V&A engagement with external stakeholders on evidence and access.
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10 years of hands-on CX/UX strategist at a large global enterprise experience, agency, consulting or Start-up/scale-up is a must, in the context of digital product or software design and in service designSolid understanding of how to create, measure and refine consumer experience strategy based on user research, human factors, customer feedback and market data.
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Regulatory CMC experience in authoring and review of (IND, CTA, BLA, MAA) with a drug-device combination product. Regulatory CMC experience in medical device and combination product research, development and/or manufacturing.
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If you have any questions, please contact the Office of Faculty Affairs at academic@gse.harvard.edu. By the position start date of July 1, 2025, candidates will possess a doctorate or another terminal degree in human development, psychology, sociology, anthropology, cognitive science, or a related field.
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consumer affairs jobs Title: regulatory affairs in Cambridge, Anoka, Minnesota
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