- Cognizant (Boston, MA)
- **About the role** As a ** Validation Lead with Veeva DMS/QMS / Veeva Clinical** , you will make an impact by driving the validation strategy and ... validation processes. **In this role, you will:** . Lead the testing strategy for Document Management Systems, ensuring...need to have to be considered** . **Experience with Veeva Clinical or Veeva DMS/QMS platforms.** +… more
- Cognizant (Boston, MA)
- **About the role** As a ** Validation Lead - MES Serialization** , you will make an impact by leading the testing and validation strategy for enterprise-level ... and business teams across global locations. **In this role, you will:** + Lead the testing strategy for Document Management Systems, ensuring robust, compliant, and… more
- Sanofi Group (Cambridge, MA)
- …between regulatory SMEs, business process owners, and digital product teams, and lead the development of scalable and compliant solutions that support Sanofi ... workshop programs and testing strategies to support solution development and validation . **Compliance & Operational Excellence** : + Develop enterprise compliance… more
- Sumitomo Pharma (Boston, MA)
- …**_This role requires proficiency in implementing, integration, and managing Medidata & Veeva clinical systems (eg CTMS, EDC etc.) in a regulated environment_** ... through their full lifecycle, from implementation to ongoing optimization + Lead and initiate troubleshooting quality and/or functionality issues associated with… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **Summary:** The Regulatory Data Governance Lead will ensure Regulatory information and data standards are aligned with ... and eDMS systems. + Oversee the execution of data remediation, migration validation , and quality control activities. + Liaise with DD&T, GRO, and cross-functional… more
- Astellas Pharma (Westborough, MA)
- …review and approval of key GMP documentation such as method validation protocols and reports, discrepancies, investigations, and related documentation. The ... the following:Perform and oversee QA review and approval of method validation and verification of protocols, reports, discrepancies, and other related documentation… more
- Takeda Pharmaceuticals (Boston, MA)
- …documents including but not limited to requirement specifications, functional specifications and validation documents + Lead E2B program expansion based on ... OBJECTIVES:** + The ideal candidate will serve as subject matter expert and lead business administration of safety database and develop/manage code changes to the… more
- Takeda Pharmaceuticals (Boston, MA)
- …data remediation efforts as needed to ensure high data quality. + Lead initiatives for regulatory information standards adoption and ensure organizational readiness ... process functionality. + Support system release management, data migration and validation activities. + Collaborate with GRA functions, regions, and local operating… more