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Job statement: The Research Associate (Scientific Communications) works with the Head of Scientific and Medical Affairs, as well as staff from other departments, to efficiently communicate technical plans and progress to internal and external stakeholders by writing concise scientific reports, protocols, articles, regulatory submissions, presentations, and other content as needed in the field of innovative medical diagnostics development.
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Reporting directly to the Head Medical Affairs Operations, the Senior Manager/Associate Director will be responsible for supporting and managing development of abstracts, posters, oral presentations at scientific congresses, submission of manuscripts to scientific journals, development of scientific communication platform, and congress planning.
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The Associate Scientific Director (ASD) for the Duchenne Regulatory Science Consortium (D-RSC) will work with leadership and interdisciplinary and cross functional teams comprised of project managers, clinical, data and quantitative medicine scientists, and regulatory experts, to advance novel drug development tools to address unmet medical needs for Duchenne muscular dystrophy and other.
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This position independently manages relationships with internal (CSPV, Regulatory, Clinical, Medical Affairs, HEOR and other stakeholders to ensure expectations are clearly defined and met across participating teams) and external stakeholders.
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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The Senior Counsel will report to and work closely with the VP & Associate General Counsel, Global Operations, to support and partner effectively with the Global Operations and Global Scientific & Regulatory Affairs teams in the US and globally.
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This role requires close collaboration with specialists in various areas including veterinary science, bacterial process development, vaccine formulation, manufacturing, bioinformatics, intellectual property, assay development, immunology, animal experimentation, pathology, regulatory affairs, and marketing.
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Lead late-stage drug product development activities including scale-up, design of experiments (DOEs), risk assessments, and development of the integrated control strategy in partnership with other CMC functional areas, Quality, Regulatory Affairs, and Manufacturing.
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As a Clinical Scientist/Associate Medical Director, Clinical Development, this candidate will work cross-functionally to develop strong relationships with key stakeholders within Clinical Development, Clinical Operations, Regulatory Affairs, and Pharmacovigilance to support ongoing clinical trials and the lifecycle of the drug candidate.
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The Associate Director is responsible for contributing to the medical strategies and overall US medical affairs plan for adult cholestatic diseases, including, medical information responses (in collaboration with Medical Information), the scientific communications including poster presentations and publications (in conjunction with the Publication team), the design and medical monitoring of US-based clinical studies, and the review and approval of educational grants.
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Proven track record of being able to successfully interact with all levels of area, affiliate and internal authority across divisions (including Global Commercial Leaders, Forecasting, Clinical Development, HEOR, Medical Affairs and Regulatory, as well as peer equivalents in other market access teams and the market access community as a whole.
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Medical) team at IQVIA are experienced in submissions for all major regions; working together with key groups such as, Global Regulatory Affairs, Safety, Project and Data Management, and Medical Writing, to.
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Collaborate with epidemiology colleagues and Product Safety Lead to identify research gaps, develop protocols, conduct analyses, and interpret/communicate scientific findings to internal and/or external stakeholders.
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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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Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination Products And Devices
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The Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination Products and Devices, combines the knowledge of scientific, regulatory, and business issues to support labeling for products that are developed, manufactured or distributed to meet required legislation.
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