- Gilead Sciences, Inc. (Parsippany, NJ)
- …accountabilities with focus on health and evolution of the Gilead R&D Quality Management System (QMS): 1) drive intelligence change management activities, ie ... to ensure proactive compliance, and 2) serve as R&D Quality integration lead to facilitate effective integration with Gilead's...related to Gilead's QMS. These activities will span GLP, GCP , GVP requirements as well as core elements of… more
- BeOne Medicines (Emeryville, CA)
- The Director of Comparator Purchasing, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain vision and strategy providing leadership ... Strong ability to collaborate and build strategic relationships with internal ( Clinical Operations, Quality , CMC, Regulatory, etc.) stakeholders. + Demonstrates… more
- ICON Clinical Research (San Antonio, TX)
- …to shape the future of clinical development. **_We are currently seeking a Medical Director to join our diverse and dynamic team. As a Medical Director at ... are seeking an MD/DO with 5+ years of practical clinical medical experience._** **Title:** Medical Director /Physician **Location:**...conducted in compliance with the study protocol and Good Clinical Practice ( GCP ) as set out in… more
- Ascendis Pharma (Princeton, NJ)
- …a dynamic workplace for employees to grow and develop their skills. Associate Director , Global Patient Safety Medical Science reports to Head of GPS Medical Science. ... activities. + Conducts medical review, assessment, and approval of ICSRs from clinical trials and post-marketing. + Ensures that all safety reports received from… more
- Amgen (Washington, DC)
- … clinical programs for Amgen's Early Development Obesity/CV pipeline. The Medical Director will lead the early phase clinical development of compounds from ... for a career you can be proud of. **Medical Director - Early Development - Cardio-metabolic, US - Remote**...clinical imaging endpoints + A record of high quality peer-reviewed publications + An understanding of regulatory requirements… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical development, medical affairs ... improvement + Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice… more
- Lilly (Indianapolis, IN)
- …for the final delivery of data collection instruments (English/Translations) used in clinical trials. The C/T associate director also provides guidance on ... **Portfolio Trial Support:** + Research scales and measurement of criteria needed for clinical trials. + Perform quality review of documents to be provided… more
- Guthrie (Sayre, PA)
- …& Compliance + Deep understanding of human-subjects research compliance (AAHRPP, FDA, IRB, GCP , ICH). + Experience in integrating clinical research into health ... organization. Its mission is to support, facilitate, and grow high-impact clinical , translational, and basic science research that enhances patient outcomes and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to optimize laboratory data processes, technology, and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical ... develops and proposes strategies for laboratory data ensuring all clinical trials meets quality requirements and best...expertise to promote and implement best practices across the Clinical Trial lifecycle. - Applies GCP principles… more
- Amgen (Washington, DC)
- …regulatory discipline. + 10+ years of experience in clinical development, clinical operations, or clinical quality assurance within pharmaceutical, ... In this vital role you will collaborate cross-functionally with stakeholders across Clinical Development, Clinical Operations, Quality , Transformation, and… more
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