- Philips (Cambridge, MA)
- The Director of Regulatory Affairs & Quality will lead the Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams in ... quality team/QMS responsibilities. **Your role:** + Leading Regulatory Affairs strategy end-to-end execution (product inception... resources in an efficient and effective manner. Represent regulatory affairs and quality on… more
- Takeda Pharmaceuticals (Lexington, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Affairs CMC where you will develop and ... lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned... CMC team, you will report to a Senior Director and work with stakeholders across the business. **How… more
- CVS Health (Boston, MA)
- …Summary** CVS Health, a Fortune 4 company, has an outstanding opportunity for a Medical Director - Medical Affairs . We need a Board Certified Oncologist for this ... product development, Enterprise Analytics, Compliance, Legal, Accreditation) and clients. The Medical Director (Medical Affairs ) will report into the Medical … more
- Boston University (Boston, MA)
- As a pivotal leader within the Division of Student Affairs , the Director of Residence Life reports to the Senior Associate Dean of Students and oversees a large ... and multifaceted residential program. The Director provides strategic vision, leadership, and management to foster...Life program that aligns with the Division of Student Affairs ' mission, values, and strategic priorities. Ensure that all… more
- AbbVie (Cambridge, MA)
- …and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and ... activities (promotional material generation/product launches) and market access. Drives Medical Affairs input into and influences the development of asset strategy.… more
- Philips (Cambridge, MA)
- **Senior Director of Clinical Affairs ** Delivers clinical knowledge, experience and expertise across the whole value chain from ideation to end-of-life. Focus in ... topics to support strategy development and strategy execution. + Build Clinical Affairs , Market Access and outcomes research capability and governance (together with… more
- Philips (Cambridge, MA)
- …ensure an effective Quality System is maintained. + Reporting to the Director of Regulatory Affairs -Ultrasound, you will collaborate with regulatory ... The Principal Regulatory Affairs Specialist will play a...regulatory professionals in their development; drive improvement in regulatory aspects of the Quality Management System… more
- AbbVie (Cambridge, MA)
- …supported by medical communication standards, pharmacovigilance standards, SOP's and all other quality and compliance standards in Medical Affairs . + Providing ... discovery, statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + Ability to work effectively in a team/matrix environment. Ability… more
- Orchard Therapeutics (Boston, MA)
- Reporting to: Sr. Director , Medical Affairs Location: United States, Boston, MA Job Summary The Medical Affairs Operations and Medical Information Scientist ... programs. This individual works in partnership with the broader Medical Affairs organization and with cross-functional partners to ensure effective execution of… more
- ThermoFisher Scientific (Tewksbury, MA)
- …cross-functional team on projects to ensure project progress. + Promptly advise the Clinical Affairs Director and project core teams of any clinical study issues ... solutions for some of the toughest challenges in science. **Job Title: Clinical Affairs Manager** **Job Responsibilities:** + Participate as a Clinical Affairs … more
- Veterans Affairs, Veterans Health Administration (Boston, MA)
- …stress and PTSD. 4. Prepares and ensures compliance with all research regulatory requirements. 5. Prepares and submits initial, ongoing, and final reporting ... research focused committees including editorial boards, grant review panels, and regulatory boards. 1. Academic/Teaching/Training (5% effort) - Will hold a faculty… more
- Veterans Affairs, Veterans Health Administration (Manchester, NH)
- …is responsible for strategic planning to ensure the provision of high - quality , cost-effective mental health services, as well as developing and implementing short- ... strategic plans. The incumbent is responsible for ensuring compliance with accrediting and regulatory agencies as well as monitoring key metrics for the service. The… more
- Olympus Corporation of the Americas (Westborough, MA)
- …effectiveness of clinical trial operations. + In close collaboration with Clinical Quality Affairs , develop and maintain Standard Operating Procedures (SOPs), ... entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Director , Clinical Project Management - US reports directly to the Executive … more
- Olympus Corporation of the Americas (Westborough, MA)
- …Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... requests for additional information from regulators ensuring communicationsadhere the Global Quality System and applicable regulatory requirements. + Responsible… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... effectiveness of clinical trial operations. + In close collaboration with Clinical Quality Affairs , supports the development and maintenance of Standard… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule where you... regulatory and business issues to ensure the regulatory filings are of high quality and… more
- Pfizer (Cambridge, MA)
- …CMAO, Medical Affairs Strategy, Biostatistics & Data Management, Global Regulatory Affairs , Clinical Pharmacology / Pharmacometrics, Market Access, Business ... Managers, IEP Success Leads, category-dedicated team leads for Clinical Affairs & Clinical Operations, Study Quality &...expert as assigned with study / analytical KOLs, key regulatory agencies (eg, FDA in the US, EMA in… more
- Regeneron Pharmaceuticals (Boston, MA)
- …closely with key stakeholders , including pre-clinical research, Regeneron Genetics Center, regulatory affairs , clinical operations, and others. This role leads ... The Senior Medical Director , Clinical Development will play a key role...advisory boards), internal stakeholders (eg, Research, Regeneron Genetics Center, Regulatory Affairs , Global Clinical Development, Precision Medicine,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the best of my knowledge. **Job Description** **Objectives:** + The Associate Director , Global Scientific Communications, Mature Brands, is a dynamic, strategic role ... within Global Medical Affairs that collaborates with cross-functional partners to own one...planning and execution for mature brands. + The Associate Director , Global Medical Communications is a key decision maker… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …best of my knowledge. **Job Description** **About the role:** Join Takeda as a Director , Outcomes Research - New Product Planning (NPP) where you will provide US ... launch timeframe. You will be part of US Medical Affairs and is responsible for developing and executing health...timepoints of development. You will report to the Sr. Director , Outcomes Research - NPP. This is a hybrid… more