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Depending on the level of experience and expertise, this role includes the opportunity to lead a cross-functional CMC team consisting of Drug Substance Development (SMPD), Analytical Development, Drug Product Development, and adjacent functions (such as QC, QA, CMC regulatory affairs, clinical supply chain) with full accountability for the CMC strategy and its successful execution.
$209,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This role reports to the Regulatory Affairs Project/Program Manager and works closely with research teams across the Cancer Center and MGB hospitals to ensure regulatory compliance for multiple trials.
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Minimum of 3-5 years of experience in regulatory affairs, compliance, or a related field within a healthcare setting. Collaborate with clinical, administrative, and support departments to ensure an integrated approach to regulatory compliance.
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D. graduates in various areas of industry pharmacy including regulatory affairs, medical information/affairs, patient safety, outcomes research, and many other areas. Medical Information engages cross functionally with other expertise areas such as Pharmacovigilance/Safety, Quality, Legal, Regulatory Affairs, Commercial, Clinical Operations, Clinical Development, and Information Technology, to ensure the safe, effective, and appropriate use of our therapies.
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Leads clinical program(s) and acts as a clinical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.g., Research, Regeneron Genetics Center, Regulatory Affairs, Global Clinical Development, Precision Medicine, HEOR), and internal decision committees.
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Work collaboratively with other Medical Directors, and colleagues in Biostatistics, Medical Writing, Drug Safety, Clinical Operations, Translational Medicine, and Regulatory Affairs.
$324,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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The Regulatory Affairs Coordinator (RAC) will work with investigators, sponsors, Institutional Review Boards (IRB) and research support staff to ensure that regulatory requirements are met for clinical trials.
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This role will be the IT business partner for most of the functions reporting to the Chief Medical Officer, including Clinical Development, Clinical Operations, Translational Research, Biostatistics & Programming, Pharmacovigilance, and Regulatory Affairs.
$222,800 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Act as a safety representative and facilitator between external reporting sources such as call centers, CROs and investigator sites, interface with internal departments clinical operations, medical information, regulatory affairs, product development, quality assurance, biostatistics, data management, and legal.
$42 an hourFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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In-depth knowledge of the multidisciplinary functions involved in a company’s cell therapy development process, e.g., research, clinical operations, clinical pharmacology, translational medicine, biostatistics, regulatory, safety, CMC, commercial operations.
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Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies. Global clinical research experience and experience interacting with regulatory authorities is a plus.
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Collaborates with cross-functional team members, eg, Clinical Pharmacology, Toxicology, Research, Clinical Development, Regulatory Affairs, Biostats, Data Management, Quality, CMC, QC, etc., to ensure accurate and timely completion and delivery of high-quality, scientifically-sound documents, slide decks, and publications.
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The role requires close collaboration with R&D, marketing, sales, regulatory, Medical/Clinical/Scientific Affairs, Legal and other cross-functional teams to ensure the products meet customer needs and regulatory requirements while driving business growth.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Work closely with individual clinical teams as well as functional area partners (e.g., Translational research, Precision Medicine and diagnostics, Regulatory Affairs, Market Access, Clinical Development) to identify and implement end-to-end Data Science solutions aimed at facilitating decision making.
Full-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.
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regulatory affairs clinical research jobs in Boston, IL, Hawaii
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