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Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other medical affairs activities (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, continuing medical education.
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This individual may serve as a liaison to external contract safety providers and company personnel for safety issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality and Medical Affairs.
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We seek outstanding candidates with teaching experience in the following: industry experience in entrepreneurship, drug discovery and development, cell and molecular biology, genetics, biochemistry, microbiology, laboratory instruction, biotechnology finance, regulatory affairs, clinical trials, project management, or manufacturing.
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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs (CA) Operations, the CS is responsible for execution and project management of their studies.
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Strong background in clinical research to include but not limited to, protocol editing, clinical research coordination, clinical research associate, regulatory coordinator, and/or clinical research project or program management.
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Your responsibilities as the Clinical Project Manager will include:Manage several multi-site clinical trials throughout the project's lifetime. Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICF Guidelines regarding drug development phases, clinical research, and data management methods.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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Collaborate with cross-functional teams including biostatisticians, project management, clinical data managers, scientific affairs, medical affairs, and regulatory affairs to ensure timely and accurate delivery of statistical programming deliverables.
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Prior experience in providing MSL-level support to products or devices in endocrinology and/or rare disease, including KOL development, investigator-initiated clinical trials, publications and educational programs, highly preferred.
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The Vice President of CMC Regulatory Affairs is leading the Ultragenyx's CMC Regulatory Affairs function. The leader will also be responsible for ensuring that regulatory strategy is deeply integrated into Pharmaceutical Development & Manufacturing (PDM) project teams and overall goals.
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State & Municipal Law - TFS operates in full compliance with all rules and regulations enforced by the State of Michigan's Department of Licensing and Regulatory Affairs (LARA) and Cannabis Regulatory Agency (CRA.
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Partners with all functional areas (translational research, CMC, regulatory affairs, clinical development, clinical operations, and pharmacovigilance) to build and maintain integrated project timelines, track progress, resolve conflicts, and communicate current project status.
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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The Virginia Department of Transportation (VDOT) is excited to offer and announce an opportunity to serve as a Legal Operations Analyst in the Governance & Legislative Affairs Division (GALA) in our Central Office.
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clinical trials regulatory affairs project management jobs Company: Jazz Pharmaceuticals
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