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Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical development, biostats, regulatory, nonclinical and research to support and impact development decisions.
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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Job DescriptionThe Clinical Research Coordinator B/C will assist in oversight, execution, and regulatory compliance of human subject research for clinical research projects exploring investigational treatments and diagnostic tools relating to the care of patients with Epilepsy.
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Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing.
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Oversee USF Diabetes and Endocrinology Center Research protocol regulatory compliance, including IRB submission and correspondence. Work in concert with the Clinical Director to supervise the clinical research team and to assess the clinical research program's current and future needs, i.e. infrastructure, staff, and supplies, dependent upon the number and nature of clinical research protocols.
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Keywords: Chemistry, Chemical Engineering, small molecule, pharmaceutical manufacturing, process chemistry, late stage, process development, GMP, quality, Director, AD, Assistant Director, quality, regulatory, genetic diseases, QC, pharma, CDMO, Contract Development Manufacturing Organization, CMC, drug substance.
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Works collaboratively with any department of UMMS and Member Organizations to research and resolve compliance investigations, including but not limited to, Member Organization Compliance Officers, Patient Financial Services, Reimbursement and Revenue Advisory Services, Health Information Management, Information Services and Technology, Case/Utilization Management, Quality, Pharmacy, Radiology, etc.
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Senior Research Analysts, Psychometrics, in the Patient Centered Outcomes (PCO) team, are essential contributors working across a range of projects which are conducted for our pharmaceutical clients, primarily.
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A minimum of 6 years' experience in pharmaceutical, medical, device, biotech, or clinical trial contract research industry, including minimum 2 years' experience in Quality Assurance and/or Regulatory Compliance/Affairs.
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Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field of clinical research.
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Learn more about the career areas and business divisions at wellsfargojobs.com. Equities Sales and Trading Compliance provides coverage for Cash, Derivatives, Electronic Trading, Research Sales, Corporate Access, and Prime Brokerage units within Wells Fargo's Corporate and Investment Bank.
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Review audits and ongoing monitoring of DEA compliance, FDA compliance, PDMP compliance, OSHA compliance, HIPAA and HITECH compliance, and Boards of Pharmacy regulatory compliance, and compliance with client KPIs. Partner with the CCO to the design and maintenance of quality programs, including but not limited to QA plans, inspection procedures, work instructions, training, deviation investigations and CAPA management, facility mapping and validation projects.
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Interest or experience in environmental planning and regulatory compliance (California Environmental Quality Act, National Environmental Policy Act, and National Historic Preservation Act (Section 106) and historic preservation.
$65,820 - $111,894 a yearPart-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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Specialty Pharmaceutical Sales Rep/Clinical Specialist (Chicago South) Title: Specialty Pharmaceutical Sales Rep/Clinical Specialist. Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses.
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clinical research pharmaceutical company regulatory compliance jobs Title: senior director
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