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Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liasions to ensure successful implementation of CDx and data collection.
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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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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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This role will develop and lead all medical affairs activities ensuring partnership within the team (medical strategy, scientific communications and publications) all key Medical Affairs functions (Medical Excellence, HEOR, Field Medical, Medical Information) as well as maintaining a high-level cross-functional collaboration across the organization to ensure alignment and One Insmed approach.
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Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent experience.
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The Scientific Director, US Medical Affairs, Endocrinology will serve as a scientific/medical expert to lead and manage strategic initiatives and projects that integrate Recordati’s scientific, clinical data into programs that drive business and medical affairs priorities.
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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 5 days ago - UpvoteDownvoteShare Job
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This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. 4 or More Years of direct regulatory affairs experience, including US labeling experience required.
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An advanced degree (MS, PhD, MD, or PharmD) in a scientific discipline is preferred. Make recommendations and provide advice and guidance about labeling content, processes, timelines, and scientific integrity.
$131,000 - $225,400 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The Senior Director of Clinical Development Medical Affairs (CDMA) oversees the strategic planning and execution of our nitric oxide program, ensuring alignment with brand objectives, incorporation of insights, and the development of an R&D plan addressing unmet patient needs and competitive differentiation.
$245,000 - $255,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The Senior Director, Clinical Development Medical Affairs continually seeks to increase clinical/scientific awareness and expertise by fostering relationships with outside organizations/experts to support research programs and licensed product maintenance and optimization.
$215,000 - $275,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago
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