- Novo Nordisk (Lexington, MA)
- …documents to regulatory agencies. Relationships Report to a Director of Regulatory Affairs . Develop and maintain positive rapport and working relationships ... with other personnel in Regulatory Affairs and other local and headquarter...submitting responses to agency queries + Create and maintain product/ project database to record history of questions asked /… more
- Gilead Sciences, Inc. (Boston, MA)
- …impact. Join Gilead and help create possible, together. **Job Description** Job Description Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a...oversees other team members representing RA Labeling on RA Project Teams, at cross-functional submission team meetings, and on… more
- ConvaTec (Lexington, MA)
- …unexpected event, crisis or project timeline pressure as may occur within the regulatory affairs industry. Our products make a big difference every day. So ... please visit http://www.convatecgroup.com **Job Summary:** In this role as a Senior Regulatory Affairs Specialist at Convatec, you will be responsible 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
- Medtronic (Boston, MA)
- …own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory team for Medtronic's ... potential acquisitions may also be required. This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unit and will be responsible… 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
- Harvard University (Cambridge, MA)
- 65265BRAuto req ID:65265BRJob Code:S0558M FSS Academic Affairs Mgt IV Department Office Location:USA - MA - Cambridge Business Title:Associate Director for ... Experience in state licensure and regulations compliance + Strong project management experience + Knowledge of Microsoft Office Suite,...where business and operational needs allow. You and your manager will discuss the best schedule based on your… more
- Veterans Affairs, Veterans Health Administration (Manchester, NH)
- …healthcare engineering advisor, engineer consultant, engineer designer, contract administrator, project manager , construction coordinator, and instructor during ... serves as a Project Engineer at an assigned Department of Veterans Affairs (VA) Healthcare System. This position performs project planning, produces designs,… 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
- 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
- J&J Family of Companies (Boston, MA)
- …protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Senior Local Trial Manager (Sr. LTM) ... Senior Local Trial Manager - Immunology - 2406178158W **Description** Johnson &...for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries.… more
- Randstad US (Cambridge, MA)
- …of pharmaceutical industry and Project management experience within Medical Affairs , Clinical Research, Regulatory , CMC, Marketing or other drug development ... acceptable) + At least 3 years experience as a project manager leading complex pharmaceutical projects in...program level budgets across multiple projects + Knowledge of regulatory and compliance guidelines governing medical affairs … more
- J&J Family of Companies (Boston, MA)
- …As a valued member of the MedTech Product Stewardship organization under the Global Regulatory Affairs organization, she/he can be located at any J&J MedTech ... NA-United States **Organization** Medical Devices & Diagnostics Global Services, LLC (6209) **Job Function** Regulatory Affairs **Req ID:** 2406181223W 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
- Philips (Cambridge, MA)
- …Management, you will work in a dynamic organization that includes Quality, Regulatory Affairs , Medical Office, Compliance, Quality Services, and Transformations. ... quality/ regulatory standards. **Your role:** + The Senior Program Manager provides program leadership and execution of patient safety and quality… more
- Merck (Boston, MA)
- …with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs , Global Medical and Scientific Affairs to ... **Job Description** **Position Description:** **Associate Clinical Research Manager (aCRM) - Oncology** With support of other...this role is accountable for the end-to-end performance and project management for assigned protocols in a country 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
- J&J Family of Companies (Boston, MA)
- …and preventive action to be taken as needed. * Partner with R&D, Medical Affairs , Clinical, and Regulatory in the establishment of appropriate routes of ... Manager , Scientific Operations (Technical & Medical Writing) -...in Sci Ops functions charged with delivery of key regulatory and medical documents. You will lead a diverse… more
- Sanofi Group (Cambridge, MA)
- …management. + Significant experience in Medical Governance, Medical Quality, Pharmacovigilance, Regulatory Affairs , Medical Operations (at global and affiliate ... to patients with specific illnesses where treatment access is limited. **Global Senior Manager - Governance & Risk Management** sits within Specialty Care MAP and… more