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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other medical affairs activities (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, continuing medical education.
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In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs (CA) Operations, the CS is responsible for execution and project management of their studies.
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Represents Clinical Affairs line in program-wide functions on Clinical Project Team, Medical Sub Committee, Clinical Study Teams, Asset Team, Program Teams, and Regulatory Strategy teams as applicable.
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As a part of Clinical Trials Scientific Affairs, the Principal Scientist will support testing, method development and validation. Collaborate with Research & Development, Scientific Affairs, and Laboratory staff in any way applicable to support Clinical Trials.
$115,000 - $130,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Senior Regulatory Operations Associate provides trial support to the Regulatory Operations team and Regulatory Affairs and Investigator Services department, thereby contributing to the overall management of clinical trials in accordance with applicable regulatory guidelines/requirements, Tempus Compass Standard Operating Procedures (SOPs) and project specific plans.
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2) Business Relationship Management: • Foster close relationships with the Care Chemicals business and technology personnel, Quality Managers, as well as Global Product Stewardship & Regulatory Affairs colleagues, Trade Associations, and/or NGOs. • Develop and document business-specific PSRA objectives and strategies aligned with the overall business strategy.
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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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Minimum 5 years in Regulatory Affairs within any of the following industries: pet food, food, OTC drugs, medical devices or pharmaceuticals; Create and foster a climate of teamwork and effective working relationships both within Regulatory Affairs and with our internal business partners: Quality, Marketing, Legal, New Product Innovation, Science & Technology, Professional Veterinary Affairs, Supply Chain, and others to achieve the synergy needed to effectively work as a team and promote the business.
$128,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for real-world evidence studies or clinical trials (e.g., ISO, MDD/MDR, CFR) The Data Scientist – RWE will be responsible for generating Real-World Evidence (RWE) through advanced analytics and innovative approaches in the clinical trials space.
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Represents Regulatory Affairs precision medicine subject matter expertise on cross-functional/cross-regional Regulatory Teams and other Sub-teams involved with the development and validation of IVDs (e.g., Study Management, Clinical, Biomarkers) and presents to senior leadership as required.
$205,700 - $266,200Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience in regulatory compliance, performance/quality improvement, patient safety, risk management or project management preferred. This position will receive continuous guidance and mentoring by the Director of Regulatory Affairs and/or the Deputy Chief Regulatory Officer and the Chief Regulatory Officer, as applicable.
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Prior experience in providing MSL-level support to products or devices in endocrinology and/or rare disease, including KOL development, investigator-initiated clinical trials, publications and educational programs, highly preferred.
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Experience in other Medical Affairs functions (i.e., Publication Planning, Scientific communications, HEOR, etc.) Inizio Engage has a strong partnership with an emerging biopharmaceutical company in endocrinology/rare disease to support Medical Affairs activities and execution.
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Acquires and maintains a level of medical-scientific knowledge in endocrinology and/or rare disease involving clinical issues related to company’s products; able to interpret and disseminate pertinent scientific/clinical data and evaluates current and new information as it applies to company’s therapies.
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clinical trials regulatory affairs project management jobs Company: Anavex
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