- Olympus Corporation of the Americas (Westborough, MA)
- …Learn more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Global Lead Medical Affairs - Gastroenterology ... role requires the application of prior clinical knowledge and medical training to lead internal stakeholders within...+ Deep knowledge of the Gastroenterology therapeutic area and global understanding of medical affairs ,… more
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is...ensures appropriate communication, resolution and/or escalation as needed + Lead global filing and lifecycle management activities… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA/ Waltham, MA/ Morristown, NJ **About the Job** Are you ready to shape the ... in helping our teams accelerate progress. As GRA CMC lead within our team, you'll have the opportunity to...the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device… more
- Sanofi Group (Framingham, MA)
- …projects. The incumbent will work closely with key stakeholders including clinical, medical affairs , Industrial Affairs (Device Development, manufacturing, ... portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device...deliverables. + Review and approve design control deliverables. + Lead and/or support global filing and lifecycle… more
- Sanofi Group (Framingham, MA)
- …timelines; ensures appropriate communication, resolution and/or escalation as needed + Lead global filing and lifecycle management activities for device ... be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is...product changes + May serve as a regional/local regulatory lead and point of contact with medical … more
- Hologic (Marlborough, MA)
- Principal Solutions Analyst, Global IT Quality Solutions Marlborough, MA, United States Hologic, Inc. is a global leader in the development, manufacturing, and ... supply of premium diagnostic products, medical imaging systems, and surgical solutions. Our core focus...and the opportunity to make a tangible impact on global healthcare. Now is an exciting time to join… more
- Bristol Myers Squibb (Devens, MA)
- …and External Manufacturing, Regulatory Affairs , Brand Teams, Legal, Patient Safety, Medical Affairs , and Clinical Therapeutic Area Quality. This role is ... and governance committees for Cell Therapy Development and Operations, Clinical Quality, Medical Affairs , and GPS, advocating for compliance best practices and… more
- Hologic (Marlborough, MA)
- … Affairs team as a **Clinical Project Manager,** leading major US and global clinical trials across multiple phases of medical device development. You'll ... Collaborate with top talent across Clinical Development, R&D, Regulatory Affairs , Program Management, Legal, Marketing, and Operations to deliver world-class… more
- Candela Corporation (Marlborough, MA)
- …in quality / regulatory / compliance. . Expert understanding of relevant global /regional medical device regulations and standards with particular emphasis on ... State/Territory **Massachusetts** **Company Overview:** Candela Corporation is a leading global aesthetic device company with a comprehensive product portfolio and… more
- Danaher Corporation (Putnam, CT)
- …ideas into impact - innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping ... customers solve their toughest challenges. Our products serve diverse, global customer needs across a wide range of applications...position reports to the VP, Quality Assurance and Regulatory Affairs and is part of the Quality Team located… more
- Bristol Myers Squibb (Devens, MA)
- …compilation of Material Review Board (MRB) content for presentation to senior leadership, medical affairs , legal, and other program stakeholders as it relates to ... Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. They will oversee atypical events to ensure the appropriate… more
- Astellas Pharma (Westborough, MA)
- …countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping ... our focus on addressing unmet medical needs and conducting our business with ethics and...cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to… more
- Hologic (Marlborough, MA)
- …Manager,** will be instrumental in shaping our innovation pipeline by leading global , pre-stage gate concept assessments and serving as the technical and clinical ... marketing lead for new product development projects from concept to...with Med Relations on KOL Development and with Clinical Affairs on expanding product claims/indications + Promote a culture… more