- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of issues in creative ways. +… more
- ThermoFisher Scientific (Waltham, MA)
- …and pharmaceutical services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational ... for talent development within the team. Reporting to the Senior Director of Regulatory Affairs ,...compliance within LPE. Responsible for leading and developing the global RA team supporting LPE. Responsible for reviewing and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …with Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, 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)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global ... and, if applicable, ensure direct reports follow requirements. + Ensures alignment of global regulatory strategies with Sr . Management. Under minimal… more
- Sanofi Group (Cambridge, MA)
- …experience partnering with cross-functional teams is strongly preferred (eg, Medical, Regulatory Affairs , Market Access, Communications). + This position may ... **Job title** : Global Public Affairs Head, Hemophilia **Location:**...reputation. + Develop and execute external engagement strategy for senior TA leadership to establish Sanofi's commitment to science… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Global Medical Affairs Lead, Plasma-Derived Therapies Innovations where you will ... regulatory , GEO, safety, compliance. + Acts as a senior company representative interacting with external scientific leaders, patient organizations, scientific… more
- Sanofi Group (Cambridge, MA)
- ** Global Medical Affairs Advisor** **-** **VIE Contract** + Location: United States of America, Cambridge + Target start date: 01/06/2025 iMove, the Sanofi VIE ... impact on the lives of countless people worldwide. As ** Global Medical Affairs Advisor** in our Medical...which serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to… more
- Novo Nordisk (Lexington, MA)
- …personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and ... regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical...Clinical summary and overview documents in eCTD format for global regulatory submissions + Shares knowledge and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. **POSITION ACCOUNTABILITIES:** + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... true to the best of my knowledge. **Job Description** ** Senior Manager, US Medical Ad/Promo Regulatory Review**... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Liberty Utilities (Londonderry, NH)
- …achieve it.** **Purpose** This position reports directly to the Manager of Rates and Regulatory Affairs and provides complex analytical work in support of ... Senior Analyst, Regulatory Revenue Requirements Londonderry,...cost recovery models. Supports the Manager of Rates and Regulatory Affairs for studies, projects, and research… more
- Sanofi Group (Cambridge, MA)
- **Job title:** Senior Global Medical Director Ophthalmology **Location:** Cambridge, MA **About the Job** In order to pursue Sanofi's purpose of "Chasing the ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs ...that address highest unmet needs. We are an innovative global healthcare company, committed to transforming the lives of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- ConvaTec (Lexington, MA)
- …materials to support educational events, webinars and congresses, while working with the Global medical affairs team to ensure education strategy alignment to ... to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions...exception of required meeting attendance as indicated by the Sr . Medical Affairs Director or CMO. The… more
- Sanofi Group (Cambridge, MA)
- …Development & Launch teams, Regeneron alliance partners, Field Medical Leadership, Regulatory , Medical Affairs , Product Communications, and medical education ... ability to work effectively with cross-functional groups which may include Marketing, Global Marketing, Sales, Research & Development, Medical Affairs , Business… more
- Novo Nordisk (Lexington, MA)
- …the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and ... About the Department Our East Coast Global Development Hub brings together the best minds...Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive… more
- Sanofi Group (Cambridge, MA)
- …brand teams, market research, sales, managed markets, sales operations, medical affairs , business development, regulatory , research & development, manufacturing, ... **Job Title:** Head of US Commercial & Global Brand Lead, Alphamedix **Location** : Cambridge, MA...Sales, Medical, M&S, Commercial Operations, Managed Markets, and Corporate Affairs . Additionally, you will lead all aspects of launch… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and GPT, incorporating various functional strategies across functions in R&D and Global Portfolio Division (Clinical, Medical, Regulatory , Global Evidence ... the counties/LOCs as appropriate. + Develop and manage the Global Medical budget. + Acts as a senior...new indications. + Collaborates with Legal, Ethics, Compliance and Regulatory functions to ensure appropriate interactions between Global… more
- Sanofi Group (Cambridge, MA)
- …to support the business unit's brand priorities, including partnering with Public Affairs , Investor Relations, Global Media Relations, and affiliate to ensure ... branded communications. + Lead communications around key data and regulatory milestones for marketed and late-stage assets. + Maintain...agencies and associated budgets. + Liaise and partner with global Public Affairs and Corporate Affairs… more
- Pfizer (Cambridge, MA)
- …with research project leaders and projects team members, including biostatistics, regulatory affairs , clinical pharmacology, clinical scientists and development ... **ROLE SUMMARY** The purpose of the Senior Director of Clinical Research role is to...seamless transition of the new asset to the Pfizer Global Product Development (GPD) for Ph3 development. **ROLE RESPONSIBILITIES**… more
- Philips (Cambridge, MA)
- … standards + Reports on and discusses trends in product roadmaps with the Regulatory Affairs and Standards team that may require proactive negotiation, expanding ... The Senior Quality Engineer Product Safety/Compliance is a key...are fully/timely available and interpreted, products comply with all regulatory requirements and Philips policies and incidents are handled… more