- Parexel (Boston, MA)
- …basic training in clinical medicine (residency, internship etc.) This role offers the flexibility to work from home in either the US or Canada. \#LI-LB1 ... comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects. You'll also mentor junior team… more
- Sanofi Group (Cambridge, MA)
- …that could turn the impossible into possible for millions. The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us ... our patients and consumers. The Quality Documents Expert is part of the Pharmacovigilance Quality (PVQ) department in PSPV function working in an international and… more
- Sanofi Group (Cambridge, MA)
- …(SMM) responsibilities eg: leading or contributing to key study documents and activities from clinical development plans and trial set-up to clinical study report in ... team developing a molecular entity, provide input to the clinical development plan, work on the development of the clinical trial protocol, clinical trial materials,… more
- Sanofi Group (Cambridge, MA)
- …safety input into development plans + Support due diligence activities and pharmacovigilance agreements **Impact:** + Ongoing assessment of the safety status of the ... and labeling + Review, preparation, and/or contribution to questions/requests from health authorities, ethics committees/ IRBs, external partners + Management… more
- Sanofi Group (Cambridge, MA)
- …the therapeutic area project teams and cross-functional Translational Medicine Subteam from preclinical development through post-marketing. A key focus of this role ... is the path from the research phase through early clinical development including...Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. + External… more
- Sanofi Group (Cambridge, MA)
- …safety input into development plans + Support due diligence activities and pharmacovigilance agreements **Impact:** + Ongoing assessment of the safety status of the ... safety, and labeling + Review, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partners + Management of… more
- Sanofi Group (Cambridge, MA)
- …Strategic Plans for Frexalimab in line with key Strategic Imperatives. + Work together with Scientific Communications to create materials needed for external medical ... internal stakeholders including Events team, Legal, Compliance and Procurement. + Work with supporting functions within the global medical affairs neurology team… more
- Sanofi Group (Cambridge, MA)
- …expertise to the cross functional project team to conduct the clinical studies from early phases to LCM programs + Establish clinical development strategy and lead ... and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators + Responsible for the clinical… more
- Sanofi Group (Waltham, MA)
- …of technical success. + Contribute with project team members (ie: clinical, pharmacovigilance , regulatory, ) to gain Health Authorities acceptance of the plans, ... accountable from a statistical standpoint. Seek support from ...Communicate internally the trials results (Key Results Memo) and work cross-functionally (ie: clinical, safety, immunology, ) to the… more
- Sanofi Group (Cambridge, MA)
- …+ Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs + Collaborate with other medical and clinical ... and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators + Develop the clinical part of… more