- Mallinckrodt Pharmaceuticals (Boston, MA)
- …colleagues in marketing, sales, research and development, strategy/portfolio management, regulatory , and medical affairs . External collaboration includes trade ... the value and productivity of the MSL team and Medical Affairs .Essential Responsibilities:KOL EngagementDevelop relationships with KOLs in the assigned territory… more
- Parenting Journey (Boston, MA)
- …sixty years, MPDC has developed, preserved, and managed 1,400 units of quality , mixed-income housing, commercial space, and two community facilities. MPDC also ... and wellness education. Hibernian Hall at MPDC provides affordable access to high- quality arts for the community and supports emerging and established local and… more
- 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
- 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
- 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
- ThermoFisher Scientific (Waltham, MA)
- …will also be responsible for talent development within the team. Reporting to the Senior Director of Regulatory Affairs , the incumbent will serve as a member ... services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational guidance and… 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
- 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 (Brockton, MA)
- …this level. An Orthotist-Prosthetist at this level may serve as the (NCOPE) Residency Director for the site, or otherwise may be required to directly contribute to ... graded O/P staff. Conducts site surveys of commercial vendors to insure vendor regulatory compliance. Work Schedule: Monday - Friday, 8:00 am - 4:30 pm Functional… more
- Pfizer (Cambridge, MA)
- …discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings. + Represents Vaccine Clinical Affairs and may take ... activities within one or more vaccine asset programs. In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs (CA) Operations, the… more
- Takeda Pharmaceuticals (Boston, MA)
- …all applicable laws, regulations, and policies + Interact directly with Clinical, Statistics, Regulatory Affairs , and Medical Affairs to fully understand ... development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications Lead, Solid Tumors** proactively defines and… 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
- 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 ... with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely… 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
