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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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Lead and shape future clinical development strategy and clinical development plans, working closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Medical Affairs, Commercial, Non-clinical and Discovery Research for assigned studies.
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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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Oversite, direction for pharmacy clinical programs and associated compliance with regulatory (e.g. State, Federal) and quality accreditation standards (e.g. HEDIS, NCQA) for all lines of business (Commercial, Medicare Advantage, Individual, HMO, FEP.
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Leads clinical program(s) and acts as a clinical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.g., Research, Regeneron Genetics Center, Regulatory Affairs, Global Clinical Development, Precision Medicine, HEOR), and internal decision committees.
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Collaborate with cross-functional teams including medical affairs, regulatory affairs, biostatistics, and clinical operations to ensure successful planning and execution of clinical trials.
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Support projects or other initiatives from cross-functional groups and departments (i.e., Project Management teams, Scientific group, Quality/Compliance, Data Management, Biostatistics and Regulatory Affairs), and ensure adequate safety support and timely update of safety information to internal and external stakeholders.
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The AD partners with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams and ensures timely drug supply for clinical trials.
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As our Senior Director, Clinical Regulatory Affairs, you’ll lead and drive Arcellx’s clinical regulatory approval strategy and implementation and oversee post-approval regulatory requirements.
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3+ years of drug development or medical or scientific affairs experience or equivalent clinical research experience at CRO or academic institution. Assists in writing clinical documents and amendments (clinical study protocols, Investigator’s brochure, ICF template) and in the preparation of clinical content for regulatory submissions/documents, in collaboration with other clinical team members.
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Create global supply strategies, supply plans to support clinical studies; collaborate with Pharmaceutical Operations, Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors to execute the strategies for the clinical studies.
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Regulatory affairs, and medical affairs, to ensure seamless execution of clinical trials. Work closely with the regulatory affairs team to prepare and review eCTD and other.
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Kiel Laboratories is a pharmaceutical research and development company located in Flowery Branch, GA. Kiel’s core competencies include CMC Research and Development, Quality Assurance, Regulatory Affairs, Clinical Development, Business Development, and Outsourcing.
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Oversight of the staff that perform the day-to-day clinical trial adverse event processing function and serious adverse events reporting to regulatory agencies following the company policies and applicable US and international regulations.
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Collaborate closely with cross-functional teams, including clinical development/operations, regulatory affairs, clinical supply management, data management, and medical affairs, to drive quality improvements across all clinical trial processes.
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regulatory affairs jobs Title: director clinical in Troy, New York
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