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Ensure commercial direction for is provided to cross-functional teams including but not limited to product clinical development team(s), HEOR, PRA, medical affairs, manufacturing and PR. This should be proactive and facilitate the timely resolution of business-critical issues.
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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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As the lead for epidemiology function, this role will report into Head of Center for Outcomes Research, Real World Evidence and Epidemiology and will build out the strategic vision and functional capabilities for the group as the company portfolio grows.
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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). Experience in supporting post-approval studies/ clinical trials, including observational studies, PMR/PASS/PAES type of studies, disease/treatment registry type of studies, investigator-initiated studies/trials, and assessments of electronic health records like claims databases and preparation of health technology assessment (HTA) dossiers.
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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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Possesses proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late-stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature.
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The Clinical Research Director (CRD) is the primary clinical lead for programs and responsible for leading successful clinical trials for novel therapeutics for Ophthalmologic Diseases.
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The Principle Clinical Research Director (CRD) is noted as the primary clinical lead for complex programs, especially those with multiple indications. Contribute to the definition of the product value proposition (TVP), TPP and market access strategies (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects.
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Johnson and Johnson's Innovative Health Engagement and Advocacy (IHE&A) organization has been created to drive meaningful impact to participant health and wellbeing by reinventing the clinical trial experience.
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To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Associate Director, Statistical Programming for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.
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Strong knowledge of the principles of ICH GCP, FDA Regulations, EU Directives and Regulations and other relevant laws, regulations and guidance's related to the clinical research industry.
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The Associate Director, Sr. Clinical Research Scientist (CS) in Clinical Development is an important role in the company supporting the development and life cycle of drug development projects.
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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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Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics.
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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
clinical research jobs Title: director in Bridgewater, NJ
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