- Sunrise Senior Living (Arlington, MA)
- …care team members. **Quality Assurance and Regulatory Compliance** + Track, trend, and report clinical quality data to identify risk. + Participate actively as a ... and train clinical team members and is responsible for performance management , evaluations, and engagement. + Complete direct report team member staffing and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to provide medical and scientific input and strategic support for clinical development, life-cycle management and commercialization strategies and plans ... new and novel approaches to drug development Life Cycle Management (LCM) as well as partner with the US...potential impact to Takeda. You will report to the Head of US OBU Medical Affairs and the role… more
- Takeda Pharmaceuticals (Boston, MA)
- …(PSPV) team, you will report to the Vice President, Therapeutic Area Head of Gastrointestinal and Inflammation PSPV. You may manage/oversee physicians and Health ... Leaders (GSL) and PV Scientists for a compound that is **both in clinical development and marketed** in the designated therapeutic area. **How you will contribute:**… more
- Sanofi Group (Waltham, MA)
- … Clinical , Regulatory, Global Program Head , Regulatory, Immunology, Medical Writing, Data Management + S(H)e has regular interactions with Sr R&D Leaders ... support the label claims + ensure quality of the clinical data CDISC packages are delivered and...related to the development, submission, launch and life cycle management of a medium vaccine project (5-7 clinical… more
- Bristol Myers Squibb (Cambridge, MA)
- …organization across 40+ countries; including Regional Clinical Operations, Global Trial Management , Global Data Management and Trial Delivery Support. + ... in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Head of the Global Development Operations function, accountable to lead an… more
- Sanofi Group (Cambridge, MA)
- …applicable SOP(s). + Partner with US Drug Safety in the management of clinical trial adverse events, post-marketing safety data , and in the communication of ... US Medical Affairs. The Director will report to the Head of US Medical Affairs, Dermatology. This position is...is an outstanding partnership with the field medical team, Clinical Development, and Commercial to maximize the value proposition.… more
- Parexel (Boston, MA)
- …does not include any direct medical advice on patient care or management + Communicate with relevant sponsor counterparts on challenges and accomplishments related ... the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical...conduct or protocol + Review and sign off all data listings / tables, protocol deviations, datasets, for medical… more
- Olympus Corporation of the Americas (Westborough, MA)
- …as well as external scientific HCP (peer-to-peer) as well as societal engagement. + Clinical Research: To support the Global Head of Clinical Affairs ... search strategy, data appraisal, threshold of performance, and assessment of clinical benefits. Contributing authorship of Clinical Evaluation Plan (CEP), … more
- Takeda Pharmaceuticals (Boston, MA)
- …not limited: Scientific Data products (Tetrascience, ECM, SDMS). GMP Clinical Manfacturing products (MES, ERP,MODA, LIMS). Knowledge management product (PLM, ... of my knowledge. **Job Description** **_Objective / Purpose:_** The Head of Design & Delivery, PharmSci will lead the...Fortis (AF), In Silico First and digitization of internal clinical manufacturing projects + Elevate the product management… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Medical Affairs Oncology team, you will report to the Head of Medical Excellence & Scientific Training. + Responsible for identification of learning ... Takeda Oncology marketed and pipeline products, relevant disease states, and competitor data + Ensure strategic collaboration with regions and countries to better… more