- 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
- 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
- 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
- Cleveland Clinic (Weston, FL)
- …caregiver who excels in this role will: + Coordinate all aspects of clinical research trials including protocol feasibility review, IRB application, protocol ... ideal future caregiver include: + Bachelor's degree or three years of clinical research experience/training + Familiarity with medical terminology and procedures… 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
- Houston Methodist (Houston, TX)
- …capacity, with two years in a people management role + Experience in clinical research management preferred **LICENSES AND CERTIFICATIONS - REQUIRED** + N/A ... trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational … more
- Charles River Laboratories (Charleston, SC)
- …cross-functional teams (R&D, QA/QC, legal, manufacturing) to address compliance issues. + Monitor and report changes in regulatory environments and recommend ... about. **Job Summary** We are seeking a detail-oriented and knowledgeable Regulatory Compliance Engineer to ensure our products, processes, and operations comply… more
- Johns Hopkins University (Baltimore, MD)
- …protocol related regulatory /compliance tasks, and other operational functions for clinical research . **Specific duties & responsibilities:** ** Research ... with study sponsors, coordinators, and collaborators. + Organize, create, and maintain clinical research charts, manage both electronic and paper-based filing… more
- HonorHealth (AZ)
- …Principal Investigators, Clinical Program Leads, Regulatory , Finance, Clinical Trials Personnel, Legal Counsel, and Research Administration. Essential ... and urgent care services, a cancer care network, outpatient surgery centers, clinical research , medical education, a foundation, an accountable care… more
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