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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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The Pharmaceutical Packaging Technician II supports clinical trial projects through the packaging of clinical trial supplies; ensuring all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs.
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Clinical Research Coordinator work includes study design, protocol development, submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies.
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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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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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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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Our consultant pharmacist teams lead the industry in clinical excellence, meeting the challenges of higher acuity, greater regulatory scrutiny, and staffing constraints head-on. PharMerica’s consultant pharmacists provide clinical services that enhance facility compliance, strengthen prescriber engagement, and optimize medication therapy for our residents.
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As a Regulatory Analyst , you will work closely with the Senior Regulatory Advisor, develop compliance controls, and ensure adherence to ERCOT regulations. Research, develop, and implement compliance controls for ERCOT regulations.
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Join us as we continue to grow, the Clinical Research Coordinator under the direction of the Site Manager/Director and the Principal/Sub Investigators conducts the following according to the study protocol, company processes & procedures, and in compliance with FDA, GCP, and ICH regulations and guidelines.
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Responsibilities: Ensure compliance with regulatory requirements for working with animals in biomedical research, including the Animal Welfare Act & Regulations, the Guide for the Care and Use of Laboratory Animals, local policies, and other applicable regulations.
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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
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Our research programs encompass a broad range of biomedical research activities and areas of study, focusing on various fields such as cardiovascular disease, alcoholism, hematopoietic cancer, behavioral research, aging, and gene therapy.
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Firm Type: Law Firm, Experience: 2 Years, Job Overview: A law firm in San Diego, CA, is seeking a skilled Transactional/SEC/FINRA/Regulatory Compliance Attorney with expertise in the Investment Advisers Act of 1940, Securities Act of 1933, Investment Company Act of 1940, and other relevant regulations in the financial services industry.
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Position Summary Clinical Veterinarian The Laboratory Animal Resource Center (LARC) at a prestigious institution is seeking a customer service-oriented individual to join our team as a clinical laboratory animal veterinarian and Assistant Director.
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clinical research pharmaceutical company regulatory compliance jobs Company: Propharma
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