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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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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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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 with-and serve as a clinical research resource for-cross-functional colleagues (e.g. in clinical operations, statistics, regulatory affairs, medical affairs, health economics outcomes research, commercial, finance) to optimize product development.
$265,000 - $285,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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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.
$150ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Work in close collaboration with different functions including preclinical toxicology, preclinical pharmacokinetics, preclinical research, translational medicine, regulatory affairs, biometrics and clinical research.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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Provide support to the GPCH or CDH in interactions with external partners (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal partners (e.g., clinical trial team, Medical Affairs, Commercial, Health Economics & Outcomes Research), and decision boards.
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Medical Expertise: Stay current with oncology advancements and provide medical insights to internal and external stakeholders, including preclinical teams, regulatory affairs, clinical operations, and business development.
$280,000 - $360,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Foster collaboration with cross-functional teams, including research and development, regulatory affairs, medical affairs, and commercial teams. Demonstrated ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
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This position works closely with key stake holders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure seamless supply of Clinical Trial Material.
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The Department of Regulatory Affairs at SUNY Downstate Health Sciences is seeking a full time Medical Director of Population Health / Clinical Assistant Professor (HS). Ensure compliance with regulatory and accreditation standards.
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Supports Program Lead MD and frequently lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Early Clinical Development, Medical Affairs, Marketing, HE&OR), and internal decision boards.
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Accountable for operational excellence and timely production and approval of quality clinical deliverables, including clinical plans, protocols, clinical study reports and regulatory submission documents (e.g., NDA, MAA, AR, briefing documents, investigator’s brochures) and, working wih Medical Affairs, international meeting abstracts or manuscripts intended for external publication that are based on Pfizer-sponsored clinical trials.
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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 jobs Title: clinical director in East-hartford, Connecticut
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