- Insmed Incorporated (San Diego, CA)
- …will collaborate closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs , and external partners.What ... technical expertise and system documentation.Ensure data integrity, system reliability, and regulatory compliance across all phases of clinical development.Team… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional ... communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from...therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical… more
- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Insmed Incorporated (NJ)
- … regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with ... Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve... CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries. As a strategic function,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …health authority regulatory requirements particularly in the areas of Medical Affairs and Clinical Development; Must have a strong understanding of ... in quality and compliance.Evaluate risks impacting GxP compliance within Medical Affairs , driving ongoing improvements to meet regulatory requirements and… more
- Insmed Incorporated (NJ)
- …Medical Operations, Medical Information, Medical Grants, HEOR, Medical Education, Clinical Development, Legal, Regulatory , Commercial, Market Access, etc.Who ... future of science, we're in. Are you?About the Role:The Medical Director, Medical Affairs - Dermatology role will be responsible for supporting the product through… more
- Nura Bio (South San Francisco, CA)
- …across diseases of the central, peripheral, and ocular nervous system. The VP/Head of Regulatory Affairs will be a key member of our clinical ... clinical , manufacturing, and quality assurance. *Monitor and interpret regulatory changes and trends and communicate their impact on...with regulatory requirements. *Mentor and develop the regulatory affairs team, fostering a culture of… more
- Tris Pharma (Monmouth Junction, NJ)
- …closely with clinical leaders, statisticians, bioanalytical teams, and regulatory affairs to inform key development decisions.Designs non- clinical ... clinical pharmacology sections of protocols, IBs, CSRs, and regulatory submissions (IND, NDA, briefing packages).Conduct noncompartmental and population PK/PD… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Management Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5… more
- Merck & Co. (Rahway, NJ)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research… more
- Merck & Co. (Rahway, NJ)
- …the Final Study ReportMaintain contact with all stakeholders (project leader, regulatory affairs , quality assurance etc.) and keeps them informed ... and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory ...(EDC) clinical studies that meet scientific and regulatory requirements by the setting of objectives, budget, resources,… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …target product profile (TPP) development, due diligence projects, and clinical - regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities ... clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop study protocols,… more
- Merck & Co. (South San Francisco, CA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a… more
- Merck & Co. (Boston, MA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the… more
- Kenai Therapeutics (San Diego, CA)
- …Cross-Functional Collaboration: Lead and collaborate with other functional areas, including Regulatory Affairs , Medical Affairs , Biometrics, and Research, ... clinical trials, with a focus on meeting project milestones, timelines, and regulatory requirements. The VP of Clinical Operations will collaborate closely… more
- Programmable Medicine Operatin (Redwood City, CA)
- … Operations, Clinical , Clinical Supply Chian, Quality Assurance, and Regulatory Affairs Responsible for drug substance and drug product and collaborating ... Programmable Medicine, a clinical stage biopharmaceutical company located in Redwood City, is seeking an experienced individual to focus on leading our contract… more
- MW Partners (Irvine, CA)
- …Excel, etc).Excellent verbal and written communication skills.Knowledge of GCP and regulatory requirements regarding clinical data management, documentation, and ... ResponsibilitiesMentor, train, and supervise junior associates as needed in clinical data management processes and procedures.Independently lead several complex… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …Job Title: Senior Associate, Clinical Research Supervisor/Manager Title: Senior Manager, Clinical Affairs Job Description Summary: The Senior Clinical ... key role in proactively supporting the conduct of pre-market clinical studies and ensure compliance with all regulatory... clinical studies and ensure compliance with all regulatory requirements. The ideal candidate will have a thorough… more
- Legend Biotech USA, Inc. (Detroit, MI)
- …point of contact between investigators and members of the Legend Biotech Medical Affairs and Clinical Development teams; Addressing AE management and education ... seeking Medical Science Liaison as part of the Medical Affairs team based in Great Lakes Territory (MI &...Direct education for healthcare professionals treating oncology patients on clinical data, adverse event management, and mechanism of action… more
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