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The Director of Statistical Programming Medical Affairs provides leadership to the group in Medical Affairs, including Health Economics and Outcomes Research (HEOR). To be considered for this opportunity, you must have the following:Bachelor's in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with 10+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.
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Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
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Prior experience in clinical development, Medical Affairs, or Global Marketing. Reporting to the Disease Area Strategy Team (DAST) Lead for GU Cancer, this position is an integral part of R&D and partners with the DAST Lead to build and execute a disease area strategy across the ADC portfolio plus emerging pipeline assets to advance our research and development.
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These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management.
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Extensive experience in medical affairs/post-approval area and execution of project user requirements, system design, validation plans, operational and performance protocols, research, and development of applications and toolkits for end-users.
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The Medical Director, Bladder - Global Medical Affairs Oncology, will be a member of the Global Medical Affairs team, leading the conduct of a global clinical study using the portfolio of compounds at Janssen with the aim of building curative regimens for patients with bladder cancer.
$187,000 - $322,000 a yearFull-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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In coordination with the CMO and other heads of Medical Affairs, develop and implement strategy and tactics for an integrated US Medical Plan for Endocrinology (Medical Education, Medical Communications and Publications, Health Outcomes, Safety and Clinical Research (Phase IIIB/Phase IV and investigator-sponsored studies (ISS.
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The Associate Director will work closely with HEOR team members and others across the company including market access, marketing, medical affairs, and clinical development to support Insmed's business needs.
$140,000 - $200,000 a yearFull-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Janssen Research & Development, L.L.C., a division of Johnson & Johnson’s Family of Companies is recruiting for an Associate Director, Global Medical Affairs, Neuroscience located in Raritan, NJ.
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The Senior Medical Director will be a standing member of the Global Medical Affairs Leadership team, Global Medical Affairs teams, and an ad hoc member of the bladder clinical teams.
$187,000 - $322,000 a yearFull-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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This position will be responsible for developing and executing robust health economics, outcomes research, epidemiology and real-world evidence plans for a leading pipeline product (oncology) in alignment with brand strategies, medical affairs strategies, clinical development plans, support product value propositions, and market access.
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The Senior Clinical Research Director (SCRD) is an expert clinical lead for one or several indications in the Development of an R&D program and is responsible for leading clinical team(s) to deliver successful clinical trials for novel therapeutics for Ophthalmologic Diseases.
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