- Merck & Co. (Boston, MA)
- …other pharmacometric analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills:Drug Discovery Process, Global Regulatory , Machine Learning, Multidisciplinary Collaboration, Multiple… more
- Merck Group (Billerica, MA)
- …Head and Program Strategy Team for a given asset and multiple Global functions (Safety, Operations, Biostats, Regulatory , Quality Assurance, Medical Affairs ... in the US. Your role: You will oversee specific medical aspects within Global Clinical Development for the Neurology Therapeutic Area, providing overall clinical and… more
- Takeda Pharmaceutical Company Limited (Cambridge, MA)
- …functional leadership, as part of the overall Asset Strategy in the Discovery, Global Product Teams, and Medical sub-teams through all stages of discovery, clinical ... define candidate biomarkers for mechanisms of action and drug response. Lead Translational Biomarker strategy development and execution to support the pre-clinical… more
- Cedent (Cambridge, MA)
- …agency meetings. Lead the preparation and submission of domestic and global regulatory documents (eg, IND, CTA, NDA/MAA) and manage response strategies ... programs. The role involves direct interaction with the FDA and global regulatory agencies, leading submissions, and providing regulatory guidance across… more
- Santander Holdings USA Inc (Boston, MA)
- …Miami Country: United States of America Your Journey Starts Here: Santander is a global leader and innovator in the financial services industry. We believe that our ... to You! The Difference you Make: As the Sr. Director , Head of Retail Network Planning you manage and...to support market entry and micro-market planning. You will lead a multi-disciplinary team and be expected to collaborate… more
- Takeda Pharmaceutical Company Limited (Cambridge, MA)
- …Expertise: Comprehensive understanding of the pharmaceutical industry and medical affairs Global regulatory expertise with demonstrated strong ability for ... to the best of my knowledge. Job Description Role Objectives: The Group Lead , Global Scientific Communications has ultimate accountability for delivering and… more
- Clinical Dynamix, Inc. (Watertown, MA)
- …Prior experience building and leading a team is a plus Expertise in global regulatory and compliance requirements for clinical research, including but not ... MA is expanding for their high profile clinical development trials. The Director , Clinical Operations is a leadership role responsible for overseeing and managing… more
- Alkeus Pharmaceuticals (Cambridge, MA)
- …and ensure operational targets are met. Ensure all trial activities adhere to applicable global regulatory and ethical standards (ie GCP, ICH, ) to support audit ... of blindness in the US Position Summary: The Associate Director is responsible for leading and managing global...clinical trials in alignment with corporate objectives and governing regulatory guidelines. The Associate Director will play… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …application is true to the best of my knowledge. Job Description Associate Director , Clinical Research, Value & Evidence Generation, US Medical Lexington, MA Hybrid ... Specific objectives include: Partners with Head of US Medical Clinical Science Lead to translate strategy into efficiently executable research plan; predicting and… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …communicating with regulatory agencies. Must have experience in global regulatory submission requirements and processes. Program Leadership ... divisional initiatives and may contribute to corporate, cross-divisional, and global initiatives Accountabilities: Program Leadership : Provides strategic scientific… more
- Natick Public Schools (Natick, MA)
- …excellence in educating students to be informed and successful citizens of a global world. We enthusiastically welcome educators to our district who seek and thrive ... Job Title Special Education Administrator Location Wilson Middle School Reports To Director of Student Services and Equity Work days/FTE 193 Salary/Benefits Unit B… 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 ... Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory...oversees direct reports or other staff responsible. The Senior Director will lead all submission types. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead ... success for the mitigation strategies proposed. + The Sr Director / Director will be accountable for all US...Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs -...Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for ... reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types...Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About ... critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs -...was possible. Ready to get started? **Main Responsibilities** + Lead the preparation, review, and maintenance of global… more
- Takeda Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... CMC related matters. + Proven ability to liaise with Regulatory Agencies, having served as lead in...international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug… more
- AbbVie (Waltham, MA)
- …. Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- Fresenius Medical Center (Waltham, MA)
- …products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the ... strategies, and potential risks to inform decision-making across the organization. + ** Global Regulatory Submissions:** + Oversee the planning, preparation, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications Lead , Hematology** proactively defines ... empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to...life sciences, and excellent project management skills. The Associate Director , Scientific Communications Lead , develops and implements… more
