- Mount Sinai Health System (New York, NY)
- …to institutional and regulatory requirements. * Stay current on relevant clinical research regulations and emerging technologies. * Monitor study ... **Responsibilities** ** Research Project Oversight:** * Manage all aspects of clinical research projects from start-up through close-out, ensuring timelines… more
- Stryker (Redmond, WA)
- …+ Identify, monitor , and submit applicable reports or notifications to regulatory authorities during the clinical research process. + Maintain ... submission through appropriate communication tools. + Evaluate proposed pre- clinical , clinical , and manufacturing changes for regulatory filing solutions and… more
- University of Southern California (Los Angeles, CA)
- …is seeking a Research Administratorto support our growing and dynamic research department. Reporting to the Senior Clinical Administrative Director II, and ... + Pre- and Post-Award Management: Oversee pre- and post-award processes for research projects, including contracts, grants, clinical trials, and philanthropic… more
- West Pharmaceutical Services (Exton, PA)
- …and automation processes to improve efficiency in supplier compliance + Monitor regulations, legislations and policies and provide regulatory guidance ... involves sitting most of the time. **Additional Requirements** + Ability to research , read, analyze, and interpret regulatory literature and documentation,… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …state/province requirements and ROW licensing activities as applicable. The Plasma Regulatory Affairs Associate will monitor and perform administrative ... and services in more than 110 countries and regions. **Summary:** Plasma Regulatory Affairs oversees the licensing, surveillance, and other regulatory activities… more
- Amgen (Washington, DC)
- …guidance and precedent + Lead the planning and implementation of global regulatory filings (eg clinical trial applications, marketing applications, label ... CMC changes) + Ensure consistency of evidence-based global product communication (eg regulatory submission documents) + Monitor and assess impact of relevant… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes, procedural ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders...around rare diseases and immune disorders **Job Summary:** The Regulatory Process Manager will be a key member of… more
- Charles River Laboratories (Malvern, PA)
- …and Care ⦁ Collaborate with stakeholders, implement test automation strategies, monitor performance metrics, and ensure regulatory compliance to drive ... Head of Biologics Testing Quality will provide direction and leadership as regulatory Subject Matter Expert in Biologics Testing Quality Systems and provide guidance… more
- Geisinger (Danville, PA)
- …analysis. + Interfaces with all research departments to coordinate and monitor compliance with applicable research regulatory requirements and reports ... of audit results. + Develops and implements research regulatory compliance education plans. + Assists...and independently carries out these audits and processes to monitor compliance with applicable research regulations. +… more
- University of Rochester (Rochester, NY)
- …data analysis software required **LICENSES AND CERTIFICATIONS** + SOCRA - Certification In Clinical Research upon hire preferred + Association of Clinical ... **Responsibilities:** GENERAL PURPOSE: Manages and oversees the activities that establish, monitor and maintain human subject research , including responsibility… more