- J&J Family of Companies (Titusville, NJ)
- …quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical ... clinical team in responding to medical and compound-related issues + Working with Regulatory Affairs and global clinical operations to respond to… more
- Cardinal Health (Helena, MT)
- …capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls Development + Nonclinical ... and Consulting + Clinical Development and Research + Medical Writing + Regulatory Publishing + Dossier Services + Submission Authoring & Filing + Quality Review… more
- BeOne Medicines (Emeryville, CA)
- …feasibility, site selection, and regulatory readiness. + Partner with Clinical Operations, Feasibility, and Medical Affairs colleagues to integrate patient ... models that strengthen representative patient enrollment. This role collaborates across Clinical Operations, Regulatory , Development, and corporate functions to… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …across clinical research activities. Reporting to the Sr. Director, Clinical Affairs , this role encompasses strategic leadership, operational oversight, and ... across clinical research activities. Reporting to the Sr. Director, Clinical Affairs , this role encompasses strategic leadership, operational oversight, and… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator A/B Job Profile Title Clinical Research Coordinator A ... This position will assist in the management of multiple clinical trials and responsibilities in specific research area. Coordinate...+ Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines + Assure compliance with the… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …of Medical Affairs to support marketed products + Coordinates seamlessly with Clinical Operations and with Regulatory Affairs + Supervises the activities ... optimal use of external resources. Further responsibilities including leading the clinical contribution to regulatory filings and handling information requests… more
- Dentsply Sirona (Charlotte, NC)
- …in dentistry, research and/or clinical studies. + 3+ years prior experience in clinical affairs , regulatory affairs , and/or clinical research ... that are sufficient for ISO 14155, EU MDR and FDA . + Preparation and submission of clinical ... study documentation to Independent Ethics Committees/Review Boards and Regulatory Authorities. + Registration of clinical studies… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …and Scientific Affairs group, an integral delivery unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable ... clinical trials. This role ensures the integrity, accuracy, and completeness of clinical trial data in compliance with regulatory standards, SOPs, and Good … more
- Takeda Pharmaceuticals (Boston, MA)
- …of Oncology Precision and Translational Medicine, Oncology Portfolio Strategy Group, Global Regulatory Affairs , Quantitative and Clinical Pharmacology, other ... (alliances and in-licensing opportunities) + Primary interface with Medical Affairs team for strategy and to support of product... clinical science activities involved in interactions with FDA , other regulatory agencies and key opinion… more
- J&J Family of Companies (Irvine, CA)
- …technical/ clinical product development experience required + In-depth knowledge of ophthalmic clinical trial design, regulatory affairs , and Good ... Clinical Practice (GCP), Inclusive Leadership, Leadership, Ophthalmology, Regulatory Affairs Management, Relationship Building, Scientific Research,… more