- Editas Medicine (Cambridge, MA)
- …leading the way towards a healthier and more equitable future. Position Summary As the Senior Manager of Regulatory Affairs , you will play a critical role in ... commercialization of our products. Key Responsibilities: As the Senior Manager , Regulatory Affairs , you will... Management tools such as SmartSheet, ThinkCell and/or Microsoft Project is key. + Regulatory Compliance: Monitor… more
- Medtronic (Boston, MA)
- … affairs documentation to support compliance with applicable regulatory requirements + Demonstrate strong project management, writing, coordination, ... Principal Regulatory Affairs Specialist - Surgical The...regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and ... various stages of development. You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines...to support their development + May serve as direct/matrix manager of RAV CMC staff, depending on project… more
- Fresenius Medical Center (Waltham, MA)
- This position can be fully remote. **PURPOSE AND SCOPE:** Develops regulatory strategies for assigned products/product lines. Prepares regulatory submissions ... and systems designed to ensure the product development process addresses all regulatory requirements as well as the objectives of the business. **PRINCIPAL DUTIES… more
- Fresenius Medical Center (Waltham, MA)
- This position can be fully remote Global Regulatory experience needed. Demonstrated project management experience needed. **PURPOSE AND SCOPE:** Ensures company ... products meet regulatory requirements by supporting all assigned regulatory ... representative on interdepartmental pharmaceuticals development teams. + Provides project team representation and direction in managing information from/to… more
- Danaher Corporation (Boston, MA)
- …diagnostic tools that address the world's biggest health challenges. The Clinical Affairs Manager for Beckman Coulter Diagnostics is responsible for directly ... You will be a part of the CCIA Clinical Affairs team and report to the Senior Manager...regulatory requirements. + Drive clinical schedule deliverables and project financial forecasts to meet the overall project… more
- Eversource Energy (Westwood, MA)
- **Our Team** The Project Manager , Regulatory will support a team that is dedicated to assisting the Rates, Revenue and Regulatory Requirements ... filings in partnership with various teams and managers\. The Project Manager 's contributions will focus on regulatory filings as well as new, emerging… more
- Beth Israel Lahey Health (Boston, MA)
- … and Accreditation Program Manager reports to the Director, Regulatory Affairs . Manages the accreditation/ regulatory program requirements related ... people's lives.** Under the direction of the Director of Regulatory Affairs , the Performance Assessment and ...quality and safety survey coordination and compliance. Acts as project resource and partner with the project … more
- Harvard University (Cambridge, MA)
- …Resources for Trials IRB Reliance platform (SMART IRB) system, the Harvard Office of Regulatory Affairs and Research Compliance (ORARC), the HLC IRB, and the ... Administration Position Description: The Epidemiology Department is seeking a Regulatory and Compliance Manager for all PHACS-affiliated research… more
- Boston University (Boston, MA)
- …- 8 years relevant experience working as a clinical research coordinator role ( project manager , research assistant, study coordinator, etc.) and/or working as an ... to best practices. The Clinical Research Resources Office (CRRO) Regulatory Education Manager will manage two important...within the CRRO (under the Office of Human Research Affairs ) as well within the BU Clinical and Translational… more
- Eversource Energy (Westwood, MA)
- …and budgets in the conceptual phase prior to execution + Interacts regularly with Regulatory Affairs , Environmental Affairs , and Energy Efficiency to develop ... **Our Team** Eversource is looking for a **Senior Program Manager , Strategic Project Development, Transmission** located in **Hartford, CT** or **Westwood, MA**… more
- Eversource Energy (Westwood, MA)
- …and budgets in the conceptual phase prior to execution + Interacts regularly with Regulatory Affairs , Environmental Affairs , and Energy Efficiency to develop ... **Our Team** Eversource is looking for a **Senior Program Manager , Strategic Project Development** located in **Hartford, CT** or **Westwood, MA** or **Hooksett,… more
- Beth Israel Lahey Health (Beverly, MA)
- …and Lynn. Beth Israel Lahey Health is seeking a dynamic Hospital Construction Project Manager to lead transformative projects for our highly rated hospitals ... the North Shore of Massachusetts. As a Hospital Construction Project Manager , you'll play a pivotal role...work streams such as IT, HR, medical equipment and regulatory affairs . Oversee establishment of package specific… more
- Blue Cross Blue Shield of Massachusetts (Boston, MA)
- …healthcare? Bring your true colors to blue. What We Need The Senior Project Manager , Scrum Master will be responsible for supporting complex projects/products ... the organization and corporate strategy. + You will be part of the Government Regulatory Affairs (GRA) Solutions team that oversees all projects within the GRA… more
- Pfizer (Cambridge, MA)
- …/ US category-led initiatives that have an impact on multiple Medical Affairs stakeholders and markets.They combine organizational, project management, financial ... **ROLE SUMMARY** The Specialty Care Operational Excellence Sr. Manager is an integral member of the Global...an integral member of the Global & US Medical Affairs Teams, and the Operational & Change Excellence Team.… more
- Pfizer (Cambridge, MA)
- …support COVID and flu vaccines, antivirals, and diagnostic assets. The Global Scientific Affairs COVID & Flu Senior Manager will deliver timely feasibility ... rules, versioning rules as care pathways evolve, standards and procedures. The Global Scientific Affairs COVID & Flu Senior Manager will play a key role in… more
- Olympus Corporation of the Americas (Westborough, MA)
- … Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... date on the latest global regulations. + Collaborate closely with the Quality, Regulatory , R&D, Business Development, Medical & Scientific Affairs , IT, and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …of the following Clinical Development functions in support of IT - Medical Affairs , Regulatory Affairs , Global Patient Safety, Clinical Operations, BioStats ... The Business Analysis & Operations Senior Manager will drive consistency across the Global Development...frameworks to bring together accurate, measurable requirements that drive project outcomes. + Create flexible processes & frameworks in… more
- Medtronic (Boston, MA)
- …balancing time, schedule, cost, and quality, while adhering to safety and regulatory standards. + Manage project financials, including forecasting and tracking ... **CAREERS THAT CHANGE LIVES:** Join Medtronic as a Program Manager in our Robotics Surgical Technology (RST) Released Product Engineering (RPE) Project … more
- Merck (Boston, MA)
- …Description** This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP ... adverse event reporting requirements internally and externally. The CRM (Clinical Research Manager ) could be responsible for a particular study for several countries… more