- Takeda Pharmaceuticals (Concord, NH)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- 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
- Sumitomo Pharma (Concord, NH)
- …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Takeda Pharmaceuticals (Concord, NH)
- …with US and EU standards and guidelines. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub ... life-changing therapies to patients worldwide. Join Takeda as the Senior Manager, Global Labeling Devices. You will...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
- Sumitomo Pharma (Concord, NH)
- …internal company programs and external facing HCP and Payer interactions. The Sr . Director of Medical Affairs develops and maintains professional relationships ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma… more
- Sumitomo Pharma (Concord, NH)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager, Medical Affairs Technology and Digital Innovation** . **Job ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...the development, implementation, execution, and oversight of Medical Information/Medical Affairs digital services and innovative digital projects as well… 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
- 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
- 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
- Sumitomo Pharma (Concord, NH)
- …and final study reporting. + Collaborate with cross-functional teams, including clinical, regulatory , and medical affairs , to ensure study designs meet ... + Interpret and communicate statistical findings to non-statistical audiences, including senior leadership, regulatory agencies, and external stakeholders. +… more
- Edwards Lifesciences (Concord, NH)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Takeda Pharmaceuticals (Concord, NH)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Takeda Pharmaceuticals (Concord, NH)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more
- Cardinal Health (Concord, NH)
- …collaborate with cross functional partners including but not limited to Global Product Management, Digital Marketing, Finance, Capital Service, Medical Affairs ... Clinical Operations Supply Chain and Operations, Research & Development, Strategic Pricing, Regulatory and Legal + Develop business proposals for national and local… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and publication plans. As part of the US Medical team, you will report to the Sr . Director, US Medical Affairs . This is a hybrid position based in Lexington, MA. ... education providers) and internal partners including grant review teams, Compliance, Legal, Global Medical Affairs + Design and implement internal communication… more