- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC Submissions Management ... requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead… more
- Philips (Cambridge, MA)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... patients around the world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new product introductions and… more
- Philips (Cambridge, MA)
- The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are ... compliant by preparing comprehensive global regulatory strategies for new devices and...regulatory compliance. + Reporting to the Head of Regulatory Affairs for AM&D, you will communicate… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to ... RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Operations; resolves a wide range of issues in creative ways. +… more
- ICON Clinical Research (Boston, MA)
- …to support scientific communication, medical education, and knowledge dissemination across global markets. ** Manager , Scientific Affairs - Hybrid** We ... Manager , Scientific Affairs - Hybrid ICON plc...scientific expertise and support to cross-functional teams, including medical affairs , marketing, and regulatory affairs .… more
- Google (Cambridge, MA)
- … Affairs and Public Policy team, you'll be part of a diverse global government affairs team, working across regions, product areas, and functions. You'll ... them. Preferred qualifications: + Experience in government relations, political campaigns, public affairs , external affairs in the northeast region. + Experience… more
- Boston University (Boston, MA)
- …documents, serving as an expert on tax compliance matters, maintaining currency on regulatory changes, leading special projects related to tax and regulatory ... with key departments such as the Investment Office and the Office of Global Programs Pay Rage: Minimum $78,000, Midpoint $117,000, Maximum $156,000. Salary is based… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. POSITION ACCOUNTABILITIES: + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... Description** About the role: Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs SOPs and processes. + Coordinate with Pharmacovigilance, Quality and Regulatory Affairs to respond to external audits and requests from external ... **About the role:** You will manage the operational conduct of Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR) and Externally… more
- AbbVie (Waltham, MA)
- …products with multiple driver indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director, or Director), ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more
- Pfizer (Cambridge, MA)
- …matrix organization and interacts with Epidemiologists, Biostatisticians, Clinical Operations, Global and Regional Medical/Scientific Affairs , Pfizer Research ... **ROLE SUMMARY** The Clinical Scientist (CS) - Sr. Manager will support clinical epidemiology study execution for multiple studies for one or more vaccine programs.… more
- Takeda Pharmaceuticals (Boston, MA)
- …Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs , Finance, Safety Statistics, etc.) contributing to aggregate ... and support of audits and inspections. + Liaises with Regulatory Affairs to coordinate synchronization of aggregate...prioritize individual and teamwork loads. + Expert knowledge of Global regulatory requirements. + Experience in vendor… more
- Abbott (Burlington, MA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... get on with their lives. **THE OPPORTUNITY** **Scientific Communications Manager ** We have an exciting opportunity for the right...for the right candidate to join our growing clinical affairs team within Abbott Heart Failure. The job purpose… more
- Sumitomo Pharma (Boston, MA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...highly motivated, and experienced individual for the position of ** Manager , Pharmacovigilance Scientist.** The Manager , Pharmacovigilance Scientist… more
- J&J Family of Companies (Boston, MA)
- …Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. The Manager Clinical Operations supports US Solid ... Manager Clinical Operations, Oncology - 2406214022W **Description** Johnson...process improvements for the assigned therapeutic area(s), country, and GCO/ Global Development (GD) overall. At Johnson & Johnson, we… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …synthetic molecules, biologics, cell therapies, and other drug modalities. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global ... of your future at Takeda. Join us as a Manager of Statistics in our Cambridge, MA office. Here,...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- Takeda Pharmaceuticals (Lexington, MA)
- …with colleagues in Pharmaceutical Sciences, Supply Chain Operations, Quality Assurance and CMC- regulatory Affairs , while serving as an important point of ... experience in development and/or manufacturing. + Experience in the GMP environment, and regulatory affairs . + Experience managing technical capabilities in a … more
- Commonwealth Care Alliance (Boston, MA)
- …guidance, direction, and practical translation of privacy requirements (legal, regulatory , contractual and, as applicable, those emanating from national ... direct and indirect reports, and may have dotted line and/or regulatory /governance oversight responsibility of other relevant areas. **Supervision Exercised:** +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs + Has knowledge of fundamental ... of playing to win CMC strategies that are in alignment with the Global Project Teams (GPTs) and Therapeutic Area Units (TAUs) strategies/goals/KPIs. + This role… more