- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** **_OBJECTIVES/PURPOSE_** The Head of Biologics Product Quality & Lifecycle Management (Sr Director ) is accountable for the ... quality liaison between Biologics Business Unit senior management and Global Quality , Regulatory Affairs, and Operations, fostering seamless communication and… more
- Merck (Boston, MA)
- **Job Description** We are seeking a dynamic and experienced Quality & Compliance Director to lead GMP compliance across our global network of internal and ... outcomes to identify trends, drive improvements, and report findings to senior quality and management councils. + ** Regulatory Consultation:** Offers proactive… more
- AbbVie (Waltham, MA)
- … to prepare submissions and partic + Makes key decisions on product quality , compliance and regulatory conformance issues for sterile, biological, liquid, ... compliance state and linking this to local / global project implementation. + Leads product quality team...or letters of intent to ensure that the appropriate quality , compliance and regulatory aspects are met… more
- Tecomet (Woburn, MA)
- …& Regulatory Affairs Manager **Department:** Quality Assurance / Regulatory Affairs **Classification:** Exempt **Reports To:** Senior Director of ... SUMMARY:** Provide overall company leadership and direction for worldwide Tecomet's Quality Assurance and Regulatory Affairs Systems, encompassing both… more
- State of Massachusetts (Boston, MA)
- …the DPH Privacy and Security Office with regular consultation with the SPHL Division Director of Quality Assurance. This position will be required to ensure that ... (DPH) seeks an experienced leader to serve as our Director , Division of Laboratory Information Management Systems. The ...analysis and result reporting, following CLIA, ISO17025, or other regulatory requirements of the MA SPHL. This position will… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director /Principal Medical Writer **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ready to shape the future of ... Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior...extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission… more
- Pfizer (Cambridge, MA)
- …into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and ... **JOB SUMMARY** The Director will plan, direct, and coordinate specialized and...interpretation, and providing statistical support and leadership in global regulatory submission activities, as well as implementing new initiatives… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Director , Patient & HUB Operations, Rare Disease** . The Director , Patient ... support program & HUB operations supporting the rare disease product(s). The Director leads the design and execution of program operations, systems, metrics, and… more
- Sanofi Group (Cambridge, MA)
- …trials (eg, historical cohorts, outcome trends in specific patient populations) and Global project /brand teams to support launches. + Ensure quality and timely ... **Job title** : Global Medical Director , Evidence Generation - Innovation & Partnerships **Location:**...engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop… more
- Takeda Pharmaceuticals (Lexington, MA)
- …regular reporting (eg, key product dashboards, financial aspects) are delivered with high quality and partner with TA Project Managers as necessary. + Oversees ... therapeutic, functional, or operational strategy. + Identifies ways to accelerate the project execution where possible while maintaining high quality standards.… more