- Sanofi (Waltham, MA)
- …Context of the job/major challenges (S)He interacts with other GBS teams, Clinical, Regulatory , Global Program Head, Regulatory , Immunology, Medical Writing, ... Job Title: Senior Project Biostatistics Lead - Vaccines Location: Waltham, MA About the Job...(when applicable), including quality, relevance to external stakeholders (eg regulatory authorities, medical journals), and scientific validity. We are… more
- Sanofi (Cambridge, MA)
- …Build internal collaborations with cross-functional teams to integrate the PDS into global and local strategies. Lead external partnerships to increase ... Job Title: Health Value Translation Lead Location: Cambridge, MA Morristown, NJ About the...helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the… more
- Sanofi (Cambridge, MA)
- …project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to ... Director (Senior CRD) within the RARE Therapeutic Area, you will be the expert clinical lead for one or several indications in the Development of an R&D program .The… more
- Sanofi (Cambridge, MA)
- …The US HEVA Head is astrategic business partner and thought leader-translating global evidence into US regional impact, delivering US specific evidence generation ... execute the US HEVA strategy across all Specialty Care therapeutic areas, aligned with global HEOR, US Medical, and Commercial priorities. Serve as a member of both… more
- Sanofi (Waltham, MA)
- …a real impact on millions of patients around the world. Main Responsibilities: Lead the cross-functional Adjuvant Platform Global Team to deliver the strategy, ... conjugate technologies. A strong matrix leader is required to lead a cross-functional Adjuvant Platform team with the mission...current and future Vaccines portfolio. We are an innovative global healthcare company that helps the world stay ahead… more
- Sanofi (Cambridge, MA)
- …teams accelerate progress. Join our Biostatistics Neuroscience and Ophthalmology team as Global Head of Neuroscience and Ophthalmology TA Biostatistics. You will be ... leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies,… more
- Sanofi (Cambridge, MA)
- …larger teams. Significant regulatory experience, with preference for experience with global regulatory submissions. This position may require up to 25% ... could be critical in helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to… more
- Sanofi (Waltham, MA)
- …accurate assessments are made for decision-making, while ensuring compliance with regulatory expectations. Main responsibilites Acts as the lead statistician ... head of Preclinical or Non-Clinical Team and/or the TED Global head who are all part of the ...the senior manager of the TED team or Research lead , participates in project activities such as assist in… more
- Sanofi (Cambridge, MA)
- …success and have a meaningful impact on patients' lives. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve ... trials, observational studies, and statistical expertise on RWE projects Lead statistical contribution to Integrated Evidence Generation plans, ensuring scientific… more
- Big Belly Solar LLC (Lawrence, MA)
- …and supplier network while enabling new product introductions and supporting global growth. Supplier Engineering Oversee the supplier engineering team responsible ... and solar component vendors. Conduct supplier audits and technical reviews, lead corrective actions and continuous improvement efforts. Partner with Supply Chain… more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the ... readiness for high-impact oncology programs. **How you will contribute:** + Lead global regulatory strategy for assigned programs across development stages.… more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the ... global regulatory team. As Associate Director, Global Regulatory Lead Oncology, you will define and lead global regulatory strategies for… more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the ... global regulatory team. As Director, Global Regulatory Lead Oncology you will set global regulatory strategy and lead major submissions… more
- Rhythm Pharmaceuticals (Boston, MA)
- …shaping and steering regulatory direction to support program success. As the Global Regulatory Lead , you will oversee your assigned programs, ensuring ... cycle management of Rhythm products. Responsibilities and Duties + Act as the Global Regulatory Lead within the cross-functional core team. + Contribute to… more
- Sanofi Group (Cambridge, MA)
- … assessment for medical devices Due Diligence activities as applicable May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes ... **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job**… more
- Takeda Pharmaceuticals (Boston, MA)
- …opportunities. + Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies on product specific ... my knowledge. **Job Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory success towards… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global ... submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains … more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** RPM&SP partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... planning _._ The intern will support the Gastrointestinal (GI) Global Regulatory Project Management & Strategic Planning...efficiently. The intern contribution will help in assisting the lead RPM to focus on strategy while ensuring operational… more
