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We are seeking an innovative and highly motivated Principal Scientist, Scientific Affairs who will contribute significantly to the development and continued growth of our advanced cell therapy manufacturing platform.
$90,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule product development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in defining innovative CMC regulatory strategies, and implementing at a platform level.
$237,660 - $307,560Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Reporting to the Director, Technical Writing, CMC Regulatory, CARGO is hiring a Senior Manager, Technical Writing to join the Technical (CMC) Regulatory writing function to help progress our cell-based gene therapy portfolio.
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Closely collaborates with various internal stakeholders such as Clinical Operations, Clinical Sciences, Regulatory Affairs, Biostatistics, Data Management, and Project Management, as well as external partners to ensure execution of pharmacovigilance activities in accordance with relevant regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Requirements:Advanced degree in life sciences in one or more of the following: MD, DO, PharmD, PhD, and 2+ years of relevant Medical Affairs (medical device/pharmaceutical industry), managed care, and HEOR experience, required.
$191,335 - $247,610Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with global regulatory agencies.
$99,361 - $136,621 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Collaborate with partners in Process Development, Regulatory, and Clinical groups to fulfill company objectives (Tech Transfer, IND filings, IP) Experience with multi-color flow cytometry, panel design, primary cell culture, cell sorting and/or data analysis is preferred.
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We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
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We are looking for a Forensic Technologist to join our eDiscovery and Information Governance Legal Team. In your role as a Forensic Technology Lead, you will focus on discovery/disclosure efforts in the various phases of the EDRM model for litigation and regulatory matters, investigations, and all other matters requiring the identification, preservation, collection, processing, and production of data.
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Maintain up-to-date knowledge of biomarker assay technologies and clinical laboratory standards, regulatory guidance (e.g., GLP, GCLP), and compliance. Lead novel assay development and timely availability of fit-for-purpose oncology clinical biomarker assays to clinical Study Teams.
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8-10+ years in pharma or biotech industry (Gene or Cell Therapy), including at least 5 years leading a Medical Affairs organization (Ophthalmology experience preferred) The Director/Senior Medical Affairs will be responsible for the alignment of internal stakeholders (Therapeutic Heads/MSLs) on a holistic engagement strategy plus executing the development of relationships within the Medical Expert community.
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Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Project Management, CMC, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents.
$180,000 - $212,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate with clinical development and medical affairs to develop plans for publication of diagnostic test results in identifying biomarker-positive patient populations. Collaborate closely with diagnostic partners and internal functions, including biostatistics, data management, medical writing, regulatory, and project management to enable regulatory submissions to support CDx approvals.
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Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities.
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This will be accomplished by implementing novel quantitative techniques and working in close partnership with other key functions such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC etc.
$166,800 - $226,800 a yearFull-timeExpandApply NowActive JobUpdated Today
regulatory affairs jobs Company: Veterans Affairs Health Administration in San Mateo, CA
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