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Duties and Responsibilities The Compliance Specialist will coordinate research compliance activities at the University's lakeside campuses to ensure regulatory compliance in human subjects research and animal research.
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This position is housed in the Clinical Research Support Office (CRSO), a centralized clinical trial management office in the UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC), which provides project management and clinical research coordinator staff, and regulatory services for oncology related clinical trials.
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At least 3-5 years of relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity including at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
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The ideal candidate will work to develop and implement policies, manuals, and procedures for various site, local, state, and federal regulatory activities to ensure compliance with radiological and environmental regulations in an industrial manufacturing setting.
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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 companys 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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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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Collaborate with Research & Development, Scientific Affairs, and Laboratory staff in any way applicable to support Clinical Trials. Ensure all methods and validations are done according to all applicable regulatory guidelines, including but not limited to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP), Medicines and Healthcare Products Regulatory Agency (MHRA), Food and Drug Administration (FDA), International Organization for Standardization (ISO), etc.
$115,000 - $130,000 a yearFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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The Regulatory & Compliance Specialist role offers an exciting opportunity to join a forward-thinking company at the forefront of the gaming and cannabis industries. Minimum of 5 years of experience in regulatory compliance, preferably in the gaming and/or cannabis industry.
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Experience with clinical development and associated Regulatory CMC submissions. Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and/or post-approval products.
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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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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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Regulatory compliance and CFR Title 21 Part 111 (cGMP in manufacturing, packaging, labeling, or holding operations for Dietary Supplements) East West Tea is seeking a talented, passionate, and experienced Principal Scientist to join our Quality Assurance team to play a pivotal role in shaping the future of Yogi, leading Regulatory Affairs, to ensure compliance and management of legal risk.
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Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to meet CMC and program goals. Thorough understanding and working experience of pharmaceutical drug products concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
$108 - $118 an hourFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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The Counsel will assist the Deputy Chief Counsel and Principal Counsel on various transactional, operational and regulatory legal matters primarily for Disney Signature Experiences (with a focus on Disney Cruise Line) and also the Walt Disney World Resort.
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This position is for a full-time Compliance Specialist to work at EAH Corporate in Tarzana, CA.The role will monitor regulatory and company policy compliance and provide support at the EAH Communities located in the Southern California and neighboring regions.
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clinical research pharmaceutical company regulatory compliance jobs Company: Wirb Copernicus Group
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