- Sanofi Group (Cambridge, MA)
- …collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug ... SOPs, GCP, ICH guidelines and other regulations + Review documents supporting clinical development such as Investigator's brochure, regulatory documents for… more
- Sanofi Group (Cambridge, MA)
- …collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug ... SOPs, GCP, ICH guidelines and other regulations. + Review documents supporting clinical development such as Investigator's brochure, regulatory documents for… more
- Sanofi Group (Cambridge, MA)
- … regulatory etc.) + Partner effectively with relevant departments (eg Commercial, Clinical Development, Regulatory Affairs , Medical Affairs , HEOR ... RELATIONSHIPS** + Regular, close contact with: + GPT members (NPP/GBL, GPH, GPM, Clinical leads, Regulatory Affairs leads, Medical ) + HEVA leads + Major… more
- Takeda Pharmaceuticals (Boston, MA)
- …and Market Access, Global Evidence and Outcomes, Medica Affairs , Clinical Development, Regulatory Affairs , Biostatistics, Global Emerging Markets ... Interaction + Market Access, Pricing, Advocacy, Biostatistics, Global Evidence and Outcomes, Medical Affairs , Clinical Science, Legal, Regulatory + OBU 10,… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical ... Affairs , Marketing, Manufacturing, and Legal. + Interact with Regulatory Authorities as part of a cross-functional team to submit and defend regulatory … more
- Astrix Technology (Boston, MA)
- …lifecycle. + Cross-Functional Collaboration: Work closely with internal teams such as Clinical Development, Regulatory Affairs , and Commercial to provide ... and communicate complex scientific data. **Preferred Qualifications** + Familiarity with clinical trial processes and regulatory requirements. + Proficiency in… more
- Takeda Pharmaceuticals (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). + Minimum… more
- Astrix Technology (Boston, MA)
- …FDA, EMA, and ICH guidelines. + Collaborate with cross-functional teams, including preclinical, clinical operations, and regulatory affairs , to integrate and ... for RNA-targeted therapeutic programs worldwide. + Ensure adherence to international clinical development and regulatory standards. **Qualifications:** + MD or… more
- Philips (Cambridge, MA)
- As a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal Regulatory Affairs Specialist will lead and provide ... to ensure an effective Quality System is maintained. Providing regulatory support for (pre-) clinical studies, including...if:** + You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical… more
- Hologic (Marlborough, MA)
- Regulatory Affairs Specialist, International Marlborough, MA, United States Louisville, CO, United States **Join Our Team: Regulatory Affairs Specialist ... Are you ready to make a real impact in healthcare innovation? As a Regulatory Affairs Specialist supporting our dynamic Surgical division at Hologic, you'll play… more