- 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 ... regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.Oncology expertise requiredClinical safety … more
- Alameda Health System (Oakland, CA)
- …adhering to federal regulations and ICH Guidelines, with an emphasis on good clinical practice and clinical Safety Data Management. Administers informed ... Clinical Research Associate + Oakland, CA + Highland...adverse events and protocol violations. Submits drug and/or device safety reports to the IRB. REGULATORY:Organizes research team and… more
- Insmed Incorporated (NJ)
- …and relevant ICH guidelines.Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving ... medical expert safety review input into all critical documents for clinical development of products including protocols and amendments, ICFs, IBs, IMPDs, … more
- BeOne Medicines (Emeryville, CA)
- …colleagues in clinical development, program leadership, biometrics, clinical operations, safety /pharmacovigilance, regulatory, molecular diagnostics, and ... equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority… more
- BeOne Medicines (Emeryville, CA)
- …colleagues in clinical development, program leadership, biometrics, clinical operations, safety /pharmacovigilance, regulatory, molecular diagnostics, and ... equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Post-Market Clinical Follow Up Reports (PMCF reports), and SSCP (Summary of safety and clinical performance). + Coordination and review of the CEP, CER, ... about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Clinical Evaluation Manager/Senior Clinical Evaluation Report Writer… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …protect patients worldwide. You will demonstrate the ability to apply your solid clinical experience, product expertise, and medical safety domain knowledge to ... and effective manner. + Demonstrates experience staying engaged with worldwide clinical practice guidelines, safety requirements, and global Competent Authority… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …data, and manage trial progress. Medical Monitoring: Provide medical oversight during clinical trials to ensure participant safety and data integrity.Review and ... desired product characteristics such as indications, target population, dosing regimen, safety profile, and clinical efficacy.Align TPPs with regulatory… more
- BeOne Medicines (Emeryville, CA)
- …Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to ... members. + Lead signal assessment documentation following BeiGene signal management and safety governance framework. ** Clinical Trial Support** + Lead the review… more
- CHRISTUS Health (Pecos, NM)
- …Department Director/Manager, is accountable for ongoing shift leadership and operations of a clinical department and for nursing care safety and quality. The ... Description POSITION SUMMARY: The Clinical Supervisor, in collaboration with and under the...provision of nursing services to patients and families. The Clinical Supervisor supports comprehensive patient and family services through… more
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