- BeOne Medicines (San Mateo, CA)
- …of global , regional, and country landscape and regulatory requirements. Drive high- quality strategic feasibility/site identification assessments ... risk assessment with therapeutic knowledge balanced with data analytics and interpretation. The Global Strategic Feasibility Analytics Lead supports the Head of … more
- AbbVie (Irvine, CA)
- …Tissue Management Science, Product Development, Clinical, Medical Affairs, Quality , Regulatory , Health Economics Outcomes Research, Global Access & Pricing ... to address gaps through internal and external innovation. This role reports to the Head of Global Pipeline Commercialization and Strategy, PRM. + Identifies the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …SOPs, company policies and regulatory guidelines to provide timely and high- quality clinical data that supports global registration and commercialization of ... help create possible, together. **Job Description** **Associate Director, Risk Based Quality Management (RBQM)** ** Global Development | Clinical Operations**… more
- Merck (Sacramento, CA)
- …safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and ... **Job Description** Our Research & Development Division Quality Assurance (QA) is an independent organization that...significant deviation with projects/products, to the QAL and TA Head . + Interfaces and provides day-to-day support to applicable… more
- Ascendis Pharma (Palo Alto, CA)
- …their skills. The Associate Director, ICSR Management Team reports to the Director, Head , ICSR Management Team within the Global Patient Safety (GPS) ... PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits +… more
- Ascendis Pharma (Palo Alto, CA)
- …to help cover a leave of absence. The ICSR Management Lead reports to the Head , ICSR Management within the Global Patient Safety (GPS) organization. Under the ... direction of the Head , ICSR Management, is responsible for all assigned ICSR...Databases (Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Working… more
- Kelly Services (South San Francisco, CA)
- …events(AOSE) and individual case comments for ICSRs. + Maintain knowledge of global regulatory authority regulations including FDA. + Represent and advise ... equity **Position Overview:** The Director, Pharmacovigilance is responsible for leading global drug safety activities, ensuring compliance with regulatory … more
- BeOne Medicines (Emeryville, CA)
- …integrate regulatory feedback to strengthen enrollment practices and operational quality . + Build and maintain relationships with research sites and external ... **General Description:** Reporting to the Head /Director of Clinical Trial Diversity, the Associate Director will operationalize BeOne's clinical trial diversity… more
- Genentech (South San Francisco, CA)
- …solutions and lifecycle governance for platform technologies + You are familiar with global regulatory guidance on digital endpoints, PROs, DCTs, and AI/ML use ... science, and digital product thinking, DEPCS delivers scalable and regulatory -ready innovations that enhance trial design, evidence generation, and clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** Reporting to the Head of Biometrics, the Executive Director of Biostatistics for Inflammation will ... (TA), and oversee all biostatistics workstreams for clinical trials, assets evaluations, and regulatory submissions in the TA. The ideal candidate will have a proven… more
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