• Associate Director, Regulatory Affairs - Labeling…

    Merck (Rahway, NJ)
    …Employee Training Programs, FDA Regulations, Management Process, Pharmacovigilance , Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, ... Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking, Systems Development Lifecycle (SDLC), Vendor Management **Preferred Skills:** **Job Posting End Date:** 08/2/2025 A job posting is effective until 11:59:59PM on the day**… more
    Merck (07/26/25)
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  • Medical Science Liaison - Rhinology…

    Sanofi Group (Orlando, FL)
    …needed on various types of studies: long-term surveillance, compliance, pharmacovigilance , and effectiveness studies + Identifies data collection opportunities ... during stakeholder interactions and reports these using approved processes. + Maintains awareness of clinical trial activity within territory and suggests clinical trials sites as requested. + Responds to unsolicited requests regarding interest in investigator… more
    Sanofi Group (07/25/25)
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  • Director, Clinical Development, Solid Tumors GI

    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 o Informed consent documents; + Investigator Brochures o… more
    BeOne Medicines (07/24/25)
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  • Vice President, DCTL, Sonrotoclax

    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:** + Protocol concepts, synopses, and amendments + Informed consent documents + Investigator Brochures + Clinical study reports + Abstracts, posters and manuscripts + Clinical sections of INDs (and equivalent applications),… more
    BeOne Medicines (07/24/25)
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  • Associate Director, Program Management

    Organon & Co. (Plymouth Meeting, PA)
    …in R&D functions (eg, Clinical Research, Early Development, Medical Affairs, Pharmacovigilance , Regulatory Affairs, etc.) + At least three years of experience ... in project management. + Proficient with MS Project, MS Timeline, and all Office products. + A working understanding of and application of principles, concepts, practices, and standards of pharmaceutical project management. + Worked on programs in one or more… more
    Organon & Co. (07/23/25)
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  • Associate Director, Affordability COE PB - Call…

    Sanofi Group (Morristown, NJ)
    …dashboards, platform queues, escalations etc. + Ensure compliance with pharmacovigilance monitoring and reporting requirements. + Ensure compliance with Sanofi ... Genzyme policies. + Recommend capabilities to scale personalized services. + Identify opportunities to streamline processes, leverage technology and champion continuous improvement. + Develop and maintain knowledge management tools, Work Instructions, SOPs,… more
    Sanofi Group (07/22/25)
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  • Director II, Clinical Development

    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 + Bachelors degree in the sciences; advanced degree (eg, MS, PhD, PharmD) preferred. + Ability to provide input and direction to clinical research with appropriate supervision. + At least 5 years of clinical… more
    AbbVie (07/22/25)
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  • Executive Director, Clinical Development, Solid…

    BeOne Medicines (San Mateo, CA)
    …clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance , regulatory, molecular diagnostics, and translational research. ... **Key roles and Responsibilities:** + Key contributor in Clinical development strategy, planning and leading presentations to various internal governance committees + Provides leadership and clinical oversight across all assigned studies and programs (up to 2… more
    BeOne Medicines (07/19/25)
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  • Instructor for Master of Science (MS)…

    University of Maryland, Baltimore (Baltimore, MD)
    …science, including: Chemistry, Manufacturing, and Controls (CMC); Clinical Research; Pharmacovigilance ; Phase IV Research (eg, Pharmacoepidemiology); and Drug and ... Biologics Discovery. Additionally, responsibilities include a Certificate in regulatory science, which is the first two courses in the MS in Regulatory Science. The student population for the program possess a diverse range of backgrounds including regulatory… more
    University of Maryland, Baltimore (07/16/25)
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  • Medical Director, Clinical Science, NS TAU- Stroke…

    Takeda Pharmaceuticals (Cambridge, MA)
    …overall safety information for studies and compound in conjunction with Pharmacovigilance . + Oversees non-medical clinical scientists 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. + Provides leadership in meetings and… more
    Takeda Pharmaceuticals (07/16/25)
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