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Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update to the teams on follow-up actions, information request, risk assessment and mitigation in support of clinical trial application and marketing application.
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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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Guides and ensures that the clinical study documentation (documents, images, and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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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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As lead of the Study Core Team the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members.
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Reporting to the Dean of Students, this role is responsible for administrative logistics for the Office of Student Affairs (Office of Student Success, Office of Student Services, Residential Life, Title IX, and the Student Center at Harvard Griffin GSAS.
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In this central role, the Associate Director will engage with multiple internal and external stakeholders such as Medical Affairs, Clinical Development, Translational Research, Clinical Pharmacology/DMPK, HEOR, Biostatistics, external authors, investigators, publishers, and medical communications agencies.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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The Creative Services team within Alumni Affairs & Development is in search of an experienced Junior Graphic Designer to fill this full-time, non-exempt position. Alumni Affairs and Development is a dedicated team supporting Harvard’s advancement activity through front-line fundraising, alumni and volunteer engagement, technology, prospect management and research, business process, events, communications, and many other areas.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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MD, PharmD or PhD with Hematology, Allergy/Immunology, or rare disease experience is requiredMinimum of 5 years of medical affairs within the pharmaceutical industry or a combination of industry and clinical experience; previous biotech medical affairs strategy experience desiredWhat additional qualifications will make you a stronger candidate.
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.
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We are a dedicated team of 400 alumni affairs and development professionals supporting Harvard's advancement activity through roles that include front-line fundraising, alumni and volunteer engagement, technology, events, communications, prospect management and research, business process, talent management and many other areas.
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We serve as key strategic partners for commercial, regulatory, R&D, market access and external affairs to develop and launch first in class and best in class therapeutic solutions that address highest unmet needs.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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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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We are seeking a dynamic and experienced pharmaceutical professional to join our team as Associate Director, Corporate Development to support the successful strategic planning and tactical execution of our corporate strategy through corporate affairs, corporate communication, financing support, and business development.
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consumer affairs jobs Title: affairs in Cambridge, Anoka, Minnesota
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