- CSL Behring (Waltham, MA)
- …and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... from PST, CDT, SMT and related delivery teams. May lead discussion at Global Regulatory Forum (GRF)...continually refine ways in which products can address unmet medical needs and help patients lead full… more
- 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
- ThermoFisher Scientific (Waltham, MA)
- …Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day ... the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual...cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial role in interpreting… 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
- Sanofi Group (Waltham, MA)
- …The incumbent is accountable for all statistical aspects of clinical development/ medical affairs plans, studies and submissions activities (when applicable), ... **Job Title:** Senior Project Biostatistics Lead - Vaccines **Location:** Waltham, MA **About the Job**...Expert at vaccine project level: + Develop with other clinical/ medical and global project team members the… more
- ThermoFisher Scientific (Waltham, MA)
- …Development Teams and cross-functional partners, including Trial Operations, medical affairs , regulatory affairs , global patient advocacy, and ... Operations at the client. The Patient Recruitment & Retention Strategy Lead encompasses strategic leadership and oversight of patient recruitment efforts across… more
- Hologic (Marlborough, MA)
- Lead Design Assurance Engineer Newark, DE, United States Marlborough, MA, United States Are you passionate about driving innovation while ensuring compliance and ... quality in medical device development? At Hologic, we are seeking a ** Lead Design Assurance Engineer** to play a pivotal role in new product development,… 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
- AbbVie (Waltham, MA)
- …internal groups including HEOR-Strategy, Clinical Development and Operations, Biostatistics, Regulatory Affairs , Medical Affairs , and the Commercial ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...patient advocacy groups). The Associate Director represents HEOR at global regulatory and payer / HTA meetings and may… more
- Fresenius Medical Center (Waltham, MA)
- …Capacity Planning, Materials Management, Distribution, Finance, Quality Systems and Regulatory Affairs , and integrated business units such as Sales and Distribution, ... in size in scope and complexity, generally focus on multi-location or global integration projects for business entities, are large-scale Business Process Project… 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
- 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
- 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
- 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
