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The NCI/NCTN Senior Regulatory Affairs Start-Up Specialist is expected to resolve, with minimal supervision, regulatory queries, and participate in the initiation of the new study, as well as, communicate transition of the new study to the applicable team Regulatory Affairs Specialist post-site initiation.
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Transamerica is organized by lines of business (Life Insurance, Annuities, Mutual Funds, Retirement Plans, and Employee Benefits), which are supported by Transamerica Corporate (Corporate Development; Finance; Internal Audit; Legislative, Regulatory & Policy; Office of the CEO; People and Places; Brand; Corporate Affairs; Risk; and Technology.
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The Clinical Research Regulatory Specialist is expected to facilitate the development of grant and clinical trial submission of applications and annual reports, development/maintenance of study-specific case report forms and source document tools, provide direct regulatory/compliance guidance, and facilitate investigator-initiated multi-site trials-additional duties relevant to regulatory affairs as assigned.
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CCRP - Cert Clin Research Prof (Preferred) or RAC - Regulatory Affairs Cert (Preferred) The Manager will also facilitate designing, improving and implementing systems to ensure efficient processing and maintenance of regulatory documents.
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We manage top-tier agencies specializing in promoting innovative solutions in advertising, medical education, clinical trial program development, sales and marketing, digital, market access, and medical and scientific affairs.
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The Sr. Director, Global Medical Affairs- Hemophilia is a critical member of the Medical Affairs and Patient Engagement leadership team and is responsible for defining the Global Medical Affairs vision, contributions to the integrated strategy (which also includes market access and marketing components) & tactics, and integrated evidence plan that support Spark’s late-stage product development and commercialization objectives through Roche.
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The Pharmaceutical Regulatory Affairs Senior Manager will use their experience and knowledge in pharmaceutical industry regulatory affairs to lead and manage complex projects for our clients in the pharmaceutical sector, and provide strategic advice, guidance, and solutions on regulatory matters.
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Partner with Federal/State government affairs in health plan drug-related issues to foster a favorable regulatory environment. Ensure regulatory compliance by reviewing new state mandates and updating internal processes to support adherence.
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Cigna Healthcare, a division of The Cigna Group, is an advocate for better health through every stage of life. The incumbent candidate can be based out of any US Cigna Healthcare office. About Cigna Healthcare.
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Must understand regulatory affairs and their applications to Quality Control and Quality Assurance; understand the application of federal, local and institutional regulations as they apply to the conduct of human subjects research.
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You’ve got at least four years’ experience in the Life Sciences R&D industry in at least one of the following areas: research, clinical development / operations, pharmacovigilance, regulatory, medical affairs, medtech, patient services, MD&D (medical device and diagnostics) or related areas (CROs), health institutions, health technology companies, etc.
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Collaborate with US Government Affairs team to identify and develop policy priorities related to commercial market access. Minimum of 10 years of experience in health policy, market access, and reimbursement, including comprehensive knowledge of commercial payment systems and the healthcare regulatory environment.
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This position requires an aplished candidate with strong academic credentials, political acumen, relationships with state Department of Insurance officials and state legislative officials and staff, as well as a developed technical background in regulatory and legislative matters for all lines of property and casualty insurance (P&C), including workers'pensation.
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Hands-on experience as a Regulatory Affairs Manager. Hands-on experience as a Regulatory Affairs Manager. SME with hands-on experience for specific business process. Able to evaluate implementation alternatives presented by the dev team and choose one of them based on estimated effort and expected UX.
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Creates and reviews monthly reports in MHP's LMS; notified the Vice President - Compliance & Regulatory Affairs of issues or outstanding training. Creates and reviews monthly reports in MHP's LMS; notified the Vice President - Compliance & Regulatory Affairs of issues or outstanding training.
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regulatory affairs jobs in Philadelphia, Columbia, Missouri
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