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In-depth knowledge of CMC regulatory requirements for Advanced Therapy Medicinal Products and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products.
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We’re a leader in staffing Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, HEOR, Market Access, and Sales & Marketing roles. Medical Science Liaison, Hematology/Oncology (Northern CA) TMAC (TMAC Direct) - San Francisco, CA, United States Tagged: MSL, Medical Affairs, Medical Science Liaison, Oncology, Hematology , Field Medical , Pharmaceutical, TMAC Direct Hire Hematology/Oncology MSL Expansion – Top BioPharma CompanyTMAC’s direct-hire service, formerly known as TMAC Direct, is an executive search firm and Pharma’s Complete Recruiting Resource.
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We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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Advanced knowledge of the international/sustainable development, public policy, and public affairs and international development job markets spanning the public, non-profit and private sector (in the US and internationally.
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Working knowledge of the international/sustainable development, public policy, and public affairs job markets spanning the public, non-profit and private sector (in the US and internationally.
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Manage regulatory affairs and ensure regulatory compliance of studies, including Institutional Review Board (IRB), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Data Safety Monitoring Board, Food and Drug Administration (FDA), and/or other funding or regulatory agency reports.
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Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience. Ensure that all investigators maintain the proper credentials and maintain these records in central regulatory binder (e.g. medical licenses, CVs, GCP/HSP certifications, NCI CTEP registration, SIP accounts, etc.
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In close partnership with Clinical R&D business process owners, sponsors & stakeholders including Clinical Science & Operations, Data Management & Biostatistics, Regulatory Affairs, PV, Biometrics, & Clinical Quality, provide leadership & subject matter expertise to drive timely & compliant planning, evaluation, procurement, implementation & operation of Clinical R&D systems.
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Hematology/Oncology MSL Expansion – Top BioPharma Company. Top BioPharma Company Expanding their Hematology/Oncology Field Team. MD, PharmD, DNP, or Ph. D. credentialing required. TMAC’s direct-hire service, formerly known as TMAC Direct, is an award-winning executive search firm that specializes in permanent placement services for the Pharmaceutical, Biotech, Diagnostics, Device, and Life Science Research industries.
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Candidates for Director, Strategy should be passionate about providing quality opinion research to drive client decision making in public policy, social marketing, candidate and ballot issue campaigns, non-profit advocacy, corporate public affairs, and government.
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Experience with clinical trials regulatory affairs, or related clinical trials experience such as clinical research coordinator experience. Assist PI with the development of concept sheets, investigational brochure or package insert for CRSO regulatory protocol editor for investigator-initiated trials.
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The current role is for a Senior Director, Regulatory Affairs to join our team and advance our platform. Minimum 8 years of relevant regulatory leadership experience in the biotech and pharmaceutical industry; gene editing/gene therapy drug development program experience is a requirement.
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Strong business acumen, analytical skills and experience working with various internal business partners (especially Sales, Marketing, Medical Affairs, Clinical, Regulatory, Legal, and Government Affairs staff) to provide insight into key market access issues.
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You will be a trusted advisor to senior management and provide guidance on a spectrum of regulatory matters at the enterprise level across all of our business units: Square, Cash App, TIDAL, TBD, Proto and Spiral.
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Reporting to the our CMC Executive Director, the CMC Regulatory Technical Writer, Associate Director/Director will be responsible for CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all CMC technical writing objectives are met.
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regulatory affairs jobs Title: regulatory affairs specialist in Oakland, CA
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