- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager , Global Regulatory Affairs , Marketed Products **POSITION ... : Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs , Marketed...submissions; Provide strategic and tactical guidance to teams, including regulatory review of clinical trial documents and… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... regulatory activities for assigned marketed product(s) of responsibility. + Provides a regulatory strategic focus on non- clinical and clinical aspects of… more
- ConvaTec (Lexington, MA)
- …as assigned **Skills & Experience:** + 5-10 years relevant experience, preferably in a regulatory affairs role in the life science industry or engineering + ... regulatory requirements and best practices specific to SaMD, clinical evidence generation, and AI/ML-based medical devices + Foster...Minimum of 5 years of experience in regulatory affairs , with a focus on software… more
- Veterans Affairs, Veterans Health Administration (West Roxbury, MA)
- …and equitable patient care. Ensures compliance with accreditation and regulatory standards. Aligns nursing/ clinical objectives with organizational strategic ... Summary This Registered Nurse - Nurse Manager - Operating Room position is within the...The NM maintains knowledge and ensures compliance with all regulatory and accreditation standards, Directives, policies, and standard operating… more
- Takeda Pharmaceuticals (Boston, MA)
- …cross-functional teams ( Clinical , Global Patient Safety, Program Management, Global Regulatory Affairs , Regulatory Operations) to plan, generate, manage, ... groups to liaise effectively with cross-functional team members (Program Management, Global Regulatory Affairs , Regulatory Operations, Drug Discovery Units,… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... therapies to patients worldwide. Join Takeda as a Senior Manager , Global Regulatory Lead Oncology where you...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Boston, MA)
- …drug and device. + Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team to ensure that ... patients with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager ) Plasma-Derived Therapies… more
- State of Massachusetts (Boston, MA)
- …maximize their skills and talents to serve our citizens. *_About the Role:_* The Manager of Regulatory and Public Data Analysis will be responsible for managing ... concerning the Division's duties as the regulator of Massachusetts insurance markets. The Manager of Regulatory and Public Data Analysis will manage the… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be responsible ... relationships among functions represented at the Labeling cross functional teams including clinical , safety, medical affairs , and commercial, to ensure highly… more
- Rhythm Pharmaceuticals (Boston, MA)
- …events + Strong collaboration skills to engage with colleagues and partner within Regulatory Affairs , Clinical Operations and other groups as needed ... learn, and our tenacity to overcome barriers, together. Opportunity Overview The Clinical Quality Assurance Manager will oversee GCP activities across various… more
- State of Massachusetts (Boston, MA)
- *Who We Are:* The Executive Office of Energy and Environmental Affairs (EEA) seeks to protect, preserve, and enhance Massachusetts' environmental resources and ... information and data systems managed within MassDEP. The IDM Manager is a key member of the BWSC senior...MassDEP Enterprise IT, the Office of Energy and Environmental Affairs (EEA), and the Executive Office of Technology Services… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Senior Product Manager , Account Engagement Marketing, US Rare Diseases **Location:** Cambridge, MA **About the Job** We are seeking a dynamic and ... strategic **Senior Product Manager ** to lead **congress strategy, execution, and KOL engagement**..., and **works cross-functionally** to align Commercial, Medical, Legal, Regulatory , and Global towards a successful "One Sanofi" approach… more
- Dana-Farber Cancer Institute (Boston, MA)
- …with clinical trial development required. + Must have expert knowledge of regulatory affairs , research ethics and the responsible conduct of research. + ... on size and scope of the project, including Translational Research Project Manager I, Clinical Research Coordinators, Research Data Specialists, Research… more
- AbbVie (Waltham, MA)
- …(Biomarker research, Regulatory , Pathology, Clinical Science, Biosample Management, Clinical Operations and Medical Affairs ) + Manage activities and tech ... a highly motivated individual to join our Precision Medicine team as a Manager , Companion Diagnostics Operations. The CDx Operations Manager will work closely… more
- Orchard Therapeutics (Boston, MA)
- …cross-functional environment that includes Patient Advocacy, Diagnostics, Commercial, Regulatory , Clinical Development, Translational Research, Business ... Reporting to: Head of Global Medical Affairs Location: Boston, MA, United States Job Summary...pull-though of overall medical strategies for approved and investigational clinical programs; and manages direct reports. This role also… more
- Globus Medical, Inc. (Methuen, MA)
- …CAPA, MDR, NCMR, and all relevant compliance activities + Work closely with Regulatory Affairs in planning, coordination, writing, and execution of 510(k), IDE ... Division is seeking an energetic and skilled Engineering Group Manager to oversee our ExcelsiusFlex orthopedic robotic system. In...+ Represent the company in a professional manner to regulatory bodies, Medical Board of Directors, Clinical … more
- Fujifilm (Boston, MA)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... for the Fujifilm Healthcare Americas Corporation IT portfolio. The Global Product Manager (GPM) is responsible for developing product plans, acting as a Product… more
- Dana-Farber Cancer Institute (Boston, MA)
- …in clinical research field is preferred. + Must have knowledge of regulatory affairs , research ethics and the responsible conduct of research. **KNOWLEDGE, ... The **Research Project Manager I (RPM I)** will support the Cohort...and staff at all levels throughout DFCI, including physicians, clinical trials managers, senior program coordinators, finance managers and… more
- Actalent (Waltham, MA)
- … clinical pipeline + Proactively partners with Process and Analytical Science, Regulatory Affairs , Quality, Manufacturing and Supply Chain teams to ensure ... Description: We are looking for an experienced CMC operations manager to join our team as Contract Manager...CMC activities related to the development and manufacturing of clinical pipeline. The ideal candidate should have relevant experience… more