- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Operations. **Job Description** **Key Responsibilities Include:** **Strategic Planning and Governance** + Lead the annual and multi-year Global and US Medical ... + Expert-level understanding of corporate governance, compliance standards, and the regulatory environment impacting global medical planning + Proven… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …the Nephrology & Immunology BU Lead and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory , Commercial) to ... relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory /legal requirements, establishing governance frameworks to ensure… more
- Wellington (Boston, MA)
- …management for high-profile brands. + Extensive knowledge of investment products, global financial markets, and the evolving regulatory landscape, with ... comprehensive investment management capabilities that span nearly all segments of the global capital markets. Our investment solutions, tailored to the unique return… more
- Astellas Pharma (Westborough, MA)
- …oversight of qualification and validation procedures and practices in accordance with global regulatory bodies (FDA, EMA, ICH, Japan guidance), Astellas policies ... and maintained in compliance with user requirements, process parameters and global regulatory guidelines. The successful candidate will foster compliance… more
- Medtronic (Mansfield, MA)
- …(https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic) **About Medtronic** We lead global healthcare ... County Fair Chance Ordinance for Employers and the California Fair Chance Act. We lead global healthcare technology and boldly attack the most challenging health… more
- Olympus Corporation of the Americas (Westborough, MA)
- …the global organization and assists development teams in applying regulatory rigor to Agile SW development practices. This position provides subject matter ... for the application of health and medical device SW regulatory standards to the Olympus SDLC, including IEC 62304,...across national and cultural boundaries. + Demonstrated capability to lead and train a large and diverse, multinational community… more
- Bristol Myers Squibb (Cambridge, MA)
- …industry RWD vendor database. + Experience in preparing and participating in global regulatory agency interactions. + Ability to communicate complex real-world ... study design using real-world data to facilitate and support development and regulatory interactions of pharmaceutical products. This position is also responsible of… more
- Lilly (Boston, MA)
- …to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work ... owned subsidiary of Eli Lilly, is seeking a Clinical Research Physician to lead the clinical trial efforts for our innovative gene editing therapies targeting… more
- Sanofi Group (Framingham, MA)
- …inspection and prepare for supportive documents for new filings or responses. Lead internal report preparation to support various regulatory activities. + ... infectious diseases and bring hope to patients and their families. **Sanofi's Global MSAT (Manufacturing Sciences, Analytics, and Technology)** acts as a crucial… more
- Bristol Myers Squibb (Devens, MA)
- …improvement of our corporate Industrial Hygiene (IH) programs across our global network, ensuring compliance with BMS standards, regulatory requirements ... strategies for industrial hygiene, ensuring alignment with company objectives and regulatory requirements. + **Program Development & Deployment:** Lead or… more