- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated ... a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other… more
- Organon & Co. (Plymouth Meeting, PA)
- …in cross-functional development programs with early clinical development, late- clinical development, regulatory affairs, safety and pharmacovigilance, ... **Job Description** **The** **Position** The Non- Clinical Safety Assessment Representative within the...position will also be responsible for reviewing and authoring non- clinical and clinical modules for regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in order to accomplish objectives. Relationship Reports to the Director, Patient Safety Data Acquisition and Support. Interacts with colleagues within Patient ... About the Department The Clinical , Medical and Regulatory (CMR) department...Patient Safety support gathering of key patient safety data for adequate assessment Support Source… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …trial data in compliance with regulatory standards, SOPs, and Good Clinical Data Management Practices (GCDMP). This position serves as a key liaison ... + Work collaboratively with other Data Managers, Programmers, Biostatisticians, Clinical Operations, Medical Directors, and Regulatory staff to meet project… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …Monitoring: Provide medical oversight during clinical trials to ensure participant safety and data integrity.Review and interpret safety signals, adverse ... such as indications, target population, dosing regimen, safety profile, and clinical efficacy.Align TPPs with regulatory requirements and commercial goals to… more
- Merck & Co. (North Wales, PA)
- … and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new ... clinical development, including study design, initiation, execution,-monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Insmed Incorporated (NJ)
- … to provide support and scientific review of adverse events and related safety data .Provide scientific review of statistical analysis plans, applicable study ... and cross functional teams. This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as… more
- Merck & Co. (Upper Gwynedd, PA)
- … development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study… more
- BeOne Medicines (Emeryville, CA)
- …key stewardship liaison for functional partners ( Clinical Ops, Safety , Regulatory , Portfolio, Research). + Collaborate with data product teams to ensure ... data stewardship teams. + Deep understanding of Pharma R&D data domains, regulatory requirements, and data standards. + Hands-on experience with… more
- Eisai, Inc (Nutley, NJ)
- …study data and develops integrated summaries of Clinical Pharmacology data as it relates to safety and efficacy.Contributes to Clinical ... of the study from protocol concept to final report including interpretation of clinical data .Serves as Medical Monitor (where applicable) to review and monitor… more
- Formation Bio (New York, NY)
- …as a project physician.Your ability to understand and navigate the complexities of healthcare data and clinical trials will be essential to your success and the ... and clinical development plans Medical leadership in the execution of clinical trials - risk assessment, operational considerations, safety and efficacy… more
- BeOne Medicines (Emeryville, CA)
- …role provides compliance oversight and guidance across Regulatory Operations, Regulatory Affairs, Quality, Safety /Pharmacovigilance, Clinical , CMC, and ... Operations manages the execution of health authority queries (HAQs), regulatory commitments, and regulatory data in BRIM, the Manager, Regulatory … more
- Kenai Therapeutics (San Diego, CA)
- …to executive management on the status of ongoing clinical programs and trials. Regulatory Compliance & Safety : Ensure that all clinical trials comply ... with a focus on meeting project milestones, timelines, and regulatory requirements. The VP of Clinical Operations...verbal communication skills, with the ability to present complex clinical data and trial parameters to both… more
- CSL Behring (King Of Prussia, PA)
- …**Summary** The primary purpose of this role is to lead the advancement of regulatory and safety intelligence. This will be achieved in close collaboration with ... Head of Global Regulatory Policy and Intelligence, GRASP, internal global regulatory and safety teams, and Competitive Intelligence (CI) team. The incumbent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...a detail-oriented and passionate Training Manager to join our Clinical , Medical, Regulatory (CMR) group at Novo… more
- Lucile Packard Children's Hospital (Palo Alto, CA)
- … clinical practice evaluation. - Locates current evidence and resources related to clinical practice * SAFETY : Minimizes risk of harm to patients, families, ... JOB SUMMARY This paragraph summarizes the general nature, level and purpose of the job. The Clinical Nurse II is an RN that practices as a full partner on the health… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role of GxP Patient Safety , Compliance & Vendor Oversight within our Clinical , Medical & Regulatory (CMR) organization. This position combines the critical ... About the Department The Clinical , Medical and Regulatory (CMR) department...and track training completion rates to ensure compliance with safety and regulatory requirements Lead the development… more
- Arvinas (New Haven, CT)
- …the writing and review of clinical study reports (CSRs), data safety update reports (DSURs), annual reports and regulatory briefing books + Manage ... will collaborate with Clinical Operations, Translational Sciences, Clinical Pharmacology, Regulatory , Research and other functions... clinical documents, the review of scientific and clinical data and the communication of … more
- Stanford Health Care (Palo Alto, CA)
- … Analysis and Reporting- Oversee the collection, analysis, and interpretation of clinical data to inform quality improvement strategies.- Prepare and present ... for leading and developing a team of Quality Consultant(s), Clinical Nurse Specialist(s), Senior Quality Consultants, and Data... and Risk Management- Lead initiatives to enhance patient safety and reduce adverse events within clinical … more
- Teleflex (Minneapolis, MN)
- …applicable regulations to evaluate protocol compliance, data accuracy, and subject safety by review of regulatory documents, medical records, reported ... projects as requested, including audits, investigator meetings, training, etc. o Interfaces with Clinical , Regulatory , Sales, and clinical site staff as… more
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