- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... compliance with applicable domestic and international regulations and applicable ICH/ GCP guidelines to ensure patient safety for company's products.Provide oversight… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **ABOUT THE ROLE** The Associate Director , GCP Audit & Compliance provides strategic quality ... adherence to GCP , GCLP, and GVP standards. This role combines audit leadership, supplier oversight, and strategic risk management to enhance end-to-end clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …improvements, procedural documents, and quality and inspection readiness for Clinical Operations. The Associate Director will be a key member of the Connect ... GCP Excellence and Inspection Readiness (GEIR) team and collaborate...execution, clinical trial sponsor oversight, deviation management and internal audit support. + Lead Clinical Operations on internal deviations… more
- University of Pennsylvania (Philadelphia, PA)
- …through communication of audit results and compliance guidelines. + The Associate Director for Regulatory Affairs will have oversight of regulatory ... of health and wellness programs and resources, and much more. Posted Job Title Associate Director , Regulatory Job Profile Title Associate Director ,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits, serves as ... Patient Safety, and other relevant departments. In partnership with GCP and E-System Audit groups, this role...Program. Reporting to the Head of GVP Audits, the Associate Director contributes to the strategic development… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical & Quality Process Compliance is responsible for ensuring ... CPMQ insights on continuous improvement that are enterprise-wide (ie Veeva, QMS, Enterprise Audit , etc.) to Global Quality and R&D Quality. Present to CPMQ at… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ensuring ... Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance. + Advanced knowledge of pharmaceutical development, medical affairs and … more
- Gilead Sciences, Inc. (Foster City, CA)
- …to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations + Analyze trends to identify process gaps, ... issues and risk mitigation actions + Collaborate with the audit , inspection and CAPA management team within Gilead R&D...new regulations and polices with emphasis Good Clinical Practices ( GCP ) and partner with business experts and stakeholders to… more
- Bristol Myers Squibb (Princeton, NJ)
- …creation and maintenance of technical specifications, process documentation, and SOX/ audit compliance artifacts. + Conduct solution reviews, validate configurations, ... & Services:** Advanced proficiency in cloud technologies (AWS, Azure, GCP ), including cloud-native architecture, migration strategies, security, and cost… more
- Lilly (Indianapolis, IN)
- …chain + Develop and implement innovative data integrity controls, automated audit trails, and intelligent data lifecycle management processes that maintain ... with modern data platforms, cloud data solutions (AWS, Azure, GCP ), data integration technologies, and API-based architectures **Additional Preferences:** +… more
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