- Eli Lilly and Company (Boston, MA)
- …to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work ... our partners and patients. Purpose of the Role: The Director [commensurate with experience], ExploR&D Translational Medicine incumbent is...of GCP Review and assist in the preparation of regulatory documents (IND, CTA, IMPD, IB, DSURs, etc.) and… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …Engage directly with regulatory agencies, representing clinical pharmacology in global regulatory meetings; contribute to regulatory deliverables, such ... true to the best of my knowledge. Job Description Senior Scientific Director , Clinical Pharmacology Boston, MA...of Phase I clinical operations, drug development processes, and global regulatory requirements. Advanced knowledge of clinical… more
- Ketryx (Boston, MA)
- …As a Client Operations Director at Ketryx, you will serve as a senior leader in a fast-growing, mission-critical team. Your role is to help our customers ... Client Operations team-and we're looking for a Client Operations Director to help lead the way. This is a...guiding teams through the intersection of product, process, and regulatory change. After mastering the Ketryx platform and approach,… more
- Alkermes (Waltham, MA)
- Job Description The Senior Medical Director / Global Safety Officer (GSO) will work closely with the DSPV leadership team and will provide strategic safety ... expertise towards Business Development/Due Diligence activities for Alkermes Neuroscience portfolio. Senior Medical Director / Global Safety Officer for… more
- AstraZeneca (Boston, MA)
- …patient partners Global external awareness within the therapeutic area and global regulatory environment Adaptive problem solving and learning and ability to ... Global Clinical Physician Lead, Executive Director ,...Global external awareness within the therapeutic area and global regulatory environment Ability to travel nationally… 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 ... on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making, monitoring slippage and developing strategies… more
- Sanofi (Cambridge, MA)
- …stretch the limits of what you thought was possible. Ready to get started? The Senior Clinical Research Director (Sr CRD) is noted as the primary clinical lead ... About the Job We are an innovative global healthcare company with one purpose: to chase...deliver to multiple operational tasks. The role of the Senior CRD is to: Act as a mentor for… more
- Alkermes (Waltham, MA)
- Job Description JOB DESCRIPTION Position Summary As an Associate Director within the INDIGO | AI Innovation Lab, you will lead the development and scaling of data ... team. You will take ownership of key projects and work closely with senior stakeholders to deliver data science-driven solutions that align with enterprise goals.… more
- Akebia Therapeutics (Cambridge, MA)
- …and management of the project timelines and budgets. In conjunction with the Senior Director , Clinical Operations and with cross-functional project team members, ... we are all in, are you? Job Summary: Reporting to the Sr. Director , Clinical Operations, the successful candidate will provide operational leadership and expertise… more
- Bayer (Cambridge, MA)
- …of brilliant and diverse minds to make a real difference, there's only one choice.** ** Senior Director , Global Regulatory Leader-IVD** The Senior ... **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Senior Director , Global Regulatory Leader-IVD are to: **Develop… 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 ... order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs, Neuroscience...success for the mitigation strategies proposed. + The Sr Director / Director will be accountable for all US… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory success towards ... and influencing the field as applicable. + Provides leadership and development for other global regulatory leads responsible for the design and execution of … more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- AbbVie (Waltham, MA)
- …. Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- Fresenius Medical Center (Waltham, MA)
- …+ ** Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical portfolio, including IND/CTAs, ... NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...potential risks to inform decision-making across the organization. + ** Global Regulatory Submissions:** + Oversee the planning,… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory , and Pharmacovigilance domains. + Strong understanding of global regulatory and safety compliance requirements and technologies supporting ... Description** **Objective / Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across Takeda's… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... you thought was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of… more
