- Sanofi Group (Cambridge, MA)
- …the relevant product life cycle stage of the asset, eg Regulatory, Pharmacovigilance , Key Market Medical asset leads, Scientific Communications teams etc to ... co-ordinate and execute the approved activities of the Global Medical Action Plans. These could include approved IEGP studies, priority data dissemination activities, launch execution activities under Medical accountability, and other key medical program/… more
- AbbVie (Mettawa, IL)
- …and the design of protocols. Expert knowledge in oncology. Must understand Pharmacovigilance practices for Clinical Development programs. . Must be able to ... communicate effectively in oral and written English. Must have overall superior communication skills. Ex-Us: At least one major international language, besides English, is preferred. . Demonstrated sense of urgency and strong goal orientation, an ability to… more
- BeOne Medicines (San Mateo, CA)
- …clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance , regulatory, molecular diagnostics, and translational research. ... **Essential Functions of the Job:** + Facilitate generation of, author, update, and/or review key documents, including, but not limited to: + Protocol concepts, synopses, protocols, and amendments + Informed consent documents + Investigator Brochures +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …that all activities of the CoE group comply with Good Clinical and Pharmacovigilance Practices, as well as all relevant internal and external regulations and ... standards. **Basic Qualifications:** Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) + Must have a MD in relevant scientific… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required. ... + Function as a subject matter expert internal and external to GPS for assigned compounds with relevant clinical industry experience in the therapeutic area of interest. + A proven ability to lead and develop a diverse team of Safety Professionals in a… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP). * Experience in training, supervising, line management, ... mentoring and development of staff, and leading a small team Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include… more
- BeOne Medicines (Emeryville, CA)
- …clinical operations, legal, compliance, new product planning, safety/ pharmacovigilance , molecular diagnostics, marketing, sales, and translational research. ... The incumbent will play a key role in establishing BeOne Medicines as a valued collaborator and best-in-class biopharmaceutical company. **Territory Includes:** (WY, CO, NM, TX, OK, AR, LA) **Essential Functions of the job:** + Work with Cross-functional teams… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …overall safety information for studies and compound in conjunction with Pharmacovigilance . + Oversees non-medical clinical scientists and, as applicable, medical ... directors with respect to assessment of these issues. + Makes final decisions regarding study conduct related to scientific integrity. External Interactions + Directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area.… more
- BeOne Medicines (San Mateo, CA)
- …clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance , regulatory, molecular diagnostics, and translational research. ... **Essential Functions of the Job:** + Facilitate generation of, author, update, and/or review key documents, including, but not limited to: + Protocol concepts, synopses, protocols, and amendments + Informed consent documents + Investigator Brochures +… more
- AbbVie (Irvine, CA)
- …health authority meetings. + Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and to all other quality ... standards in conducting research. Qualifications + Bachelor's degree in the sciences; advanced degree (eg, MS, PhD, PharmD) preferred. + At least 8 years of clinical study experience in pharmaceutical industry, academia, or equivalent. + Ability to run a… more