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The In-House CRA will be responsible for supporting the clinical operations team in planning, executing, and managing medical device clinical trials while ensuring compliance with regulatory standards and maintaining high-quality documentation within the Trial Master File (TMF) system as well as assisting in the review of study data entered into the electronic data capture (EDC) system.
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In this highly visible role, you will partner with a large, global pharmaceutical company and provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure client's products are developed/maintained in compliance with global regulatory requirements and guidances.
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Oversee risk-based vendor onboarding process to ensure compliance with company standards and regulatory requirements. JOB DESCRIPTION The Deputy Chief Ethics and Compliance Officer position is a senior-level executive role responsible for assisting in the oversight and management of an organization's compliance with laws, regulatory requirements, policies, and procedures.
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You exercise good judgment, and communicate clearly, while balancing the demands of a deadline-driven environment, and are interested in developing the necessary expertise to assist researchers in identifying steps to ensure compliance with regulatory requirements related to their research.
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The CMC Regulatory Affairs position holds a crucial role within the organization, overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory affairs for pharmaceutical products.
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HPM Faculty lead or collaborate with research centers across the University, including the Medicaid Research Center, Center for Women's Health Research and Innovation, Hillman Cancer Center, Center for Bioethics and Health Law, Center for Research on Health, and Center for Pharmaceutical Prescribing and Policy.
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5-10 years of experience in corporate insurance regulatory matters, preferably within a large law firm or corporate legal department. Provide expert legal advice and counsel on corporate insurance regulatory matters, including compliance with state and federal regulations.
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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 Research and Development, Regulatory Affairs, and Clinical Development.
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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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As a Clinical Research Coordinator I, you will work independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.
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Established in 1885, The Ohio State University College of Pharmacy is a global leader in pharmaceutical education, research and clinical practice. Our anti-cancer therapeutics research leverages our expertise in novel drug delivery systems, drug transport and membrane trafficking, basic/translational/clinical pharmacology, pharmacogenomics and pharmacometrics to improve outcomes for cancer patients.
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Firm Type: Law Firm, Experience: 3 Years, Job Overview: A law firm is seeking a skilled Mid To Senior-Level Gaming Associate Attorney to join its team in Chicago, IL. The ideal candidate will have extensive gaming law experience and be responsible for supporting litigation and regulatory matters for gaming industry clients.
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Research regulations for a wide spectrum of applications, including, but not limited to, product development, ingredients use, animal disease, labeling, USDA challenges and appeals, and export compliance, for all MFI functions and facilities.
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At least three (3) years of clinical research compliance-related responsibilities, focused in regulatory, compliance, and/or quality assurance; and. The Compliance Director is responsible for ensuring that the company’s data collection meets ALCOC standards and that all clinical research activities are conducted in accordance with ICH GCP guidelines, FDA regulations and guidance documents, Charter Research SOPs and work instructions, and applicable federal and state regulations and guidelines.
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The Research Nurse I will be responsible for rendering patient care services to patients on research protocols approved through the Northside Hospital IRB. Responsibilities involve patient registration, data collection, data submission, adverse event reporting, patient follow-up, records management, protocol regulatory management, quality assurance and other activities related to research.
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