- Editas Medicine (Cambridge, MA)
- …be responsible for articulating our off-target analysis strategy and data packages to global regulatory agencies. This is a highly cross-functional role that ... of developing safe and effective CRISPR-based medicines. You will lead a talented team of scientists performing human statistical...as the subject matter expert on off-target analysis for global regulatory submissions (IND, BLA) and agency… more
- Wellington (Boston, MA)
- …reporting + Defining business requirements and developing solutions to meet evolving global ESG/SI reporting and regulatory needs + Collaborating with Investment ... cross-functionally with Global Operations stakeholders to evaluate and prioritize new global SI regulatory initiatives + Partner with ESG-focused teams and… more
- Hologic (Marlborough, MA)
- …as the primary point of contact for privacy-related inquiries, investigations, and regulatory requests. + Lead privacy impact assessments, data mapping, and ... to join us on our mission to make our global security platform a solid differentiator in the Medical...privacy legal community, including coordinating with external counsel + Lead and cultivate professional growth of a small but… more
- Medtronic (Newton, MA)
- …(https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic) **About Medtronic** We lead global healthcare ... efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304,...for Employers and the California Fair Chance Act. We lead global healthcare technology and boldly attack… more
- Takeda Pharmaceuticals (Boston, MA)
- …use of data and emerging technologies across the business. You will lead initiatives to develop procedures, training, and monitoring plans that manage digital ... privacy risks, support privacy impact assessments, and respond to regulatory changes and incidents. As a member of both...incidents. As a member of both the OBU and Global Digital Ethics & Compliance leadership teams, you will… more
- 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
- Sanofi Group (Cambridge, MA)
- …inflammatory diseases, with a particular emphasis on rheumatology. We are an innovative global healthcare company with one purpose: to chase the miracles of science ... strategy and plans for one or more assets + Lead and coordinate cross-functional teams to design, implement, and...and studies + Align clinical development strategy with the global project team and internal partners, such as clinical… more