- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC in Cambridge, MA ... with the following requirements: Master's degree in Regulatory Affairs or related field plus 2...working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to… more
- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs , Marketed Products in ... EU, Health Canada, and other international health authorities - Support regulatory team and Global Regulatory Lead (GRL) in preparations and timely delivery… more
- Sanofi Group (Cambridge, MA)
- **Job title: Senior Manager , US Advertising & Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the job** Under ... thought was possible. Ready to get started? **Main responsibilities** + Represent Global Regulatory Affairs (GRA) US AdPromo as a member of cross-functional… more
- Takeda Pharmaceuticals (Boston, MA)
- …and implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global ... therapies to patients worldwide. Join Takeda as a Senior Manager , Regulatory Affairs Project Management...and Strategic Planning where you will Partner with the Global Regulatory Lead (GRL) on Global… more
- 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 ... in clinical development. You will collaborate closely with the global regulatory lead and cross-functional teams to...commercialization of our products. Key Responsibilities: As the Senior Manager , Regulatory Affairs , you will… 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 ... develop CMC regulatory strategy for global vaccine programs in...various stages of development. You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... awareness of recent in-class approvals. Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory Team (GRT) + Liaises with… 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
- Regeneron Pharmaceuticals (Cambridge, MA)
- …more of the following Clinical Development functions in support of IT - Medical Affairs , Regulatory Affairs , Global Patient Safety, Clinical Operations, ... The Business Analysis & Operations Senior Manager will drive consistency across the Global...Quality. Experience working within and knowledge of GXP/GCP and regulatory ICH 6 guidelines. Strong knowledge of technologies such… more
- Pfizer (Cambridge, MA)
- …and flu vaccines, antivirals, and diagnostic assets. The Global Scientific Affairs COVID & Flu Senior Manager will deliver timely feasibility assessments, ... evolve, standards and procedures. The Global Scientific Affairs COVID & Flu Senior Manager will...and other Vaccines-relevant experience is highly desired. + Understanding global regulatory guidance for appropriate use and… more
- Pfizer (Cambridge, MA)
- …, Site Excellence Partners, Site Relationship Partners, Site Care Partners, Contracts Lead, Regulatory Affairs , pCRO and others as required to ensure a ... of the larger Study Management deliverables. The Study Operations Manager partners with the Global Study ...hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory , Medical Affairs colleagues and other key… more
- ThermoFisher Scientific (Cambridge, MA)
- …on US and Canada + Ensure strategic pharmacovigilance support in the region to Regulatory Affairs , Medical Affairs , US Commercial function, and the broader ... the region. Assess current processes to ensure adherence to US safety regulatory requirements and where needed enhance and/or develop new processes while assuring… more
- Cathay Pacific Airways Limited (Boston, MA)
- Airport Operations Manager + ASD - Airport Services Delivery + Boston, Massachusetts, USA + Cathay Pacific + Application Deadline28 Jun 2024 Company Description Move ... our Hong Kong heritage but equally proud of the global , diverse workforce that makes us who we are....station, employees and suppliers are fully compliant with all regulatory requirements and quality standards + Achieve absolute operational… more
- Actalent (Boston, MA)
- …+ Partner and collaborate globally with cross-functional teams including Compliance, Legal, Regulatory Affairs , and Clinical Management. + Partner with internal ... will play a pivotal role in developing and maintaining outsourcing plans, global study budgets, Key Performance Indicators (KPI's) and metrics for CRO's and… more
- Harvard University (Cambridge, MA)
- 66094BRAuto req ID:66094BRJob Code:361060 Administrative Manager Department Office Location:USA - MA - Cambridge Business Title:Director, Program on Emerging ... Technology, Scientific Advancement & Global PolicySub-Unit: Salary Grade (https://hr.harvard.edu/salary-ranges#ranges) :060Time Status:Full-time Union:00 - Non… more
- Actalent (Boston, MA)
- Description: The Business Development Manager (BDM) is responsible for hunting new business within the vertical and segments assigned, along with bringing an ... and Diagnostic companies with Clinical Operations, Auditing, Quality, and Medical Affairs business opportunities * Qualify high value and high potential business… more
- Philips (Cambridge, MA)
- …key audiences. + Partner with clinical business teams, clinical science, clinical affairs , legal and regulatory to ensure compliance of marketing ... clinics, and radiology centers. **Your role:** As the Senior Product Marketing Manager for Radiology Informatics (RI), you will be responsible for new product… more
- J&J Family of Companies (Boston, MA)
- …including but not limited to MSL field partners, R&D, US as well as Global Medical Affairs teams, clinical operations, sales, and marketing teams * Demonstrate ... - Urology- ME, VT, NH, MA and RI - 2406193110W **Description** Janssen Scientific Affairs , LLC, a member of Johnson & Johnson's Family of Companies, is recruiting… more
- Merck (Boston, MA)
- …and Translational Medicine, Global Medical and Scientific Affairs , and Global Regulatory Affairs and Clinical Safety to identify key issues ... to collaborate with our Research & Development Division colleagues from Global Clinical Development, Biostatistics and Research Decision Sciences, the Center for… more
- J&J Family of Companies (Raynham, MA)
- …operations. **Primary Responsibilities** : * In close collaboration with Clinical Affairs Leaders, identifies and ensures global clinical strategies, resources ... for the supported franchises delivering high quality clinical data to support Regulatory , Market Access, Reimbursement and Market Adoption needs. * Responsible to… more