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Outside of the Platform, the VP will work with leaders from Biostatistics & Data Management, Global Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, HEOR, Legal/Compliance, and others to achieve research and business objectives.
$215,400 - $398,900 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Strong knowledge of model-informed drug development, DMPK-Clinical Pharmacology concepts, and regulatory requirements. A Ph. D. or PharmD with a minimum of 10 years of industry experience in pharmaceutical sciences, pharmacokinetics, clinical pharmacology, chemistry, or related fields.
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Ensure that CRO/CMO activities and other process development activities address drug substance needs for pharmaceutical formulation development, toxicology testing, clinical trials, and commercial launch.
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Experience in leading the design and implementation of clinical pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Practical experience in the pharmaceutical or biotech industry of at least five years in at least one major area of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs.
$224,000 - $270,000 a yearFull-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Located within the heart of the Bay area’s biomedical community, research conducted in our new laboratories spans exploratory biology through early clinical development and is an integral part of Merck’s powerful world-class network of drug and vaccine discovery.
$36.85 an hourFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Plan and execute client engagements focusing Operational Risk, Operational Resilience, Regulatory Compliance, Surveillance, Conduct Risk, Third Party Risk Assessments and other risk programs.
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Previous experience working in clinical research; familiar with regulatory affairs, and Good Clinical Practice (GCP); knowledge of research protocols, clinical research processes, including medical chart reviews, and regulations involving human subjects.
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Leading analytics related to the BSA/AML compliance controls for regulatory examinations, tuning and optimization of controls. Partner with Compliance Program team and Compliance Product team to facilitate the dashboarding and reporting design conversations for AML, Sanctions and KYC controls.
$145,000 - $192,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities.
$205,000 - $260,000 a yearExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Preferred Qualifications At least one year of previous experience as a clinical research coordinator or equivalent combination of experience / training Fluent in spoken and written Spanish and/or Arabic About UCSF The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.
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As the Director of Regulatory Compliance (MLRO), you will be working as part of Nium’s global, dynamic Compliance team and will be reporting to the VP Compliance (US). Identify control gaps and lead the implementation of control enhancements to include AML, OFAC, and Regulatory Compliance.
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Works collaboratively with vendors, Clinical Research, Drug Safety, Regulatory Affairs, Clinical Operation, and Project Management teams to meet project deliverables and timelines for statistical data analysis and reporting.
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We are a research site, working to develop therapeutic Client drug candidates for clinical testing. Biologics Emeryville, CA site, formerly the startup company Redwood Bioscience, has developed a proprietary approach for site-specific bioconjugation to produce next-generation ADCs. This technology, termed SMARTag, is based on use of the aldehyde-tag site-specific protein modification technology and.
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Collaborates with Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations.
Full-timeExpandApply NowActive JobUpdated 1 month ago
clinical research pharmaceutical company regulatory compliance jobs Company: Wirb Copernicus Group in San Francisco, CA
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