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Experience in providing regulatory CMC strategy for submission of clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for small molecule development compounds, including chemical drug, peptide and oligonucleotide.
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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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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.
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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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Reporting to the Senior Associate Dean for Academic Affairs and Student Services, the Academic Affairs and Student Services Coordinator will work in close collaboration and partnership with all Degree Programs team members and affiliated offices to support students and ensure successful planning, implementation, and continuous improvement.
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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.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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The role will partner closely with Pfizer Oncology stakeholder groups (including Research, Early and Late Development, Regulatory Strategy, Clinical Development and Operations, Translational Oncology, US Medical Affairs, etc.
$299,600 - $499,400 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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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.
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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 2 days ago - UpvoteDownvoteShare Job
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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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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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You will work closely with Research and Development, Corporate Strategy, the CEO, and the General Counsel to lead the design and implementation of our intellectual property (IP) affairs globally, including strategies for optimizing patent and regulatory exclusivity for cell and gene therapy products and technologies.
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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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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
ExpandApply NowActive JobUpdated 17 days ago
consumer affairs jobs Title: regulatory affairs in Cambridge, Anoka, Minnesota
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