- GRAIL (Boston, MA)
- …to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as ... when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders...information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership… more
- Parexel (Boston, MA)
- The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the ... in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and… more
- Coinbase (Boston, MA)
- …management processes. *What you'll be doing (ie. job duties):* * The Senior Associate of Regulatory Change Management (RCM) will support the management, ... connection, and alignment. Attendance is expected and fully supported. The Coinbase Regulatory Change Management (RCM) function is responsible for the… more
- Parexel (Boston, MA)
- … regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate , you will serve as the primary ... Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are...HAs to secure approvals. * Provide local input for change control and post-approval requirements. * Collaborate with global… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret ... the impact of regulatory changes to the pharmaceutical environment. **Job Description** +...coordinate projects. + Demonstrates experience interacting with and supporting senior leadership. + Previous experience with people management and… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Senior Associate Scientist, Retinal Degeneration **Location:** Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The ... for retinal diseases, including age-related macular degeneration and glaucoma. As a Senior Associate Scientist in the Retinal Degeneration group within… more
- Amgen (Cambridge, MA)
- …extensively with internal and external stakeholders ie manufacturing, suppliers, quality, regulatory , senior management, etc. + Drive and influence key ... transform the lives of patients while transforming your career. Senior Sterilization Engineer **What you will do** Let's do...Engineer **What you will do** Let's do this. Let's change the world. In this vital role you will… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …needs and nutraceutical products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and ... statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Associate Director, Scientific Communications manages the execution of the core scientific and medical communications strategy for the relevant therapeutic area ... consistency, and compliance. This position reports directly to the Senior Director, CNS Medical Communications Lead. **Key Responsibilities Include:** **Global… more
- Medtronic (Boston, MA)
- …the same wide variety of life experiences as our patients The Senior Import/Export Specialist serves as a subject-matter expert within Medtronic's Global Trade ... strategic problem-solving to support classification governance, data integrity, and regulatory adherence across import, export, and free-trade agreement processes.… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Associate Director, Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and optimize ... as well as enhance overall operational alignment. + Ensure effective change management strategies are applied to drive successful implementation and adoption… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Associate Director will serve as a key member of the Learning Center of Excellence within Global Quality, responsible for designing, implementing, and sustaining ... (G&A) functions. This role ensures that learning strategies align with regulatory requirements, corporate standards, and business objectives, fostering a culture of… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director Commercial Training Rare Blood **Location:** Cambridge, MA, Boston, MA **About the Job** Ready to push the limits of what's ... healthcare, emerging markets, animal health and the new Sanofi. The Sanofi Associate Director Commercial Training Rare Blood, reports to the Sanofi Director of… more
- Dana-Farber Cancer Institute (Boston, MA)
- The Senior Nursing Director (SND) of the Inpatient Hospital at Dana-Farber Cancer Institute is a pivotal leadership role, reporting to the Associate Chief ... SND is responsible for nursing practice, quality improvement, workforce development, regulatory compliance, fiscal planning, and strategic growth, and serves as a… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** About the role: As the Manufacturing Senior Training Coordinator, you will oversee the assignment and delivery of manufacturing ... qualification status, address gaps, and support quality systems through CAPAs and Change Controls. Present the training process during audits and inspections, ensure… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… more
- Amgen (Cambridge, MA)
- …us and transform the lives of patients while transforming your career. ** Senior Engineer: Mathematical Modeling and Simulation** **Cambridge, MA** **What you will ... do** Let's do this. Let's change the world. Amgen's Combination Product Operations Digital and...use of simulation technologies. It is expected that the Senior Engineer - Modeling and Simulation will not only… more
- Humana (Boston, MA)
- …transforming how Medicare Advantage is sold, and design is at the heart of that change . As a Senior Product Designer, you'll join a growing digital organization ... trustworthy. This is an opportunity to step into a senior role, work in an agile, fast-moving setting, and...ecosystem + Balance ideal UX with technical feasibility and regulatory requirements, knowing when to push and when to… more
- Humana (Boston, MA)
- …part of our caring community and help us put health first** The Associate Director of Cloud Infrastructure Operations is responsible for leading Humana's enterprise ... at the intersection of operations, technology, and AI innovation. The Associate Director of Cloud Infrastructure Operations will drive the evolution of… more
