- Olympus Corporation of the Americas (Center Valley, PA)
- …areas. + Execute global internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates audit corrective actions ... methodology and procedures that comply with applicable domestic and international regulatory laws/standards and all developed Olympus...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... + Various standards (GCP, ISO 13485, ISO 14971) + Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs,...time doing computer-based work + Extended hours to accommodate international / intercontinental global time schedules. + Expected to… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... periods of time doing computer-based work + Extended hours to accommodate international / intercontinental global time schedules. + While performing the duties of… more
- University of Pennsylvania (Philadelphia, PA)
- …various sponsors. This position will report directly to the Airways Program Manager and work directly with Physician Investigators ("PI") on clinical research ... subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating… more
- University of Pennsylvania (Philadelphia, PA)
- …well as completion of study related activities including but not limited to regulatory submissions, data entry, and regulatory compliance visits. + Assure ... compliance with the protocol and regulatory requirements includes collecting, recording, and maintaining data and source documentations. This involves organizing,… more
- Sanofi Group (Swiftwater, PA)
- …internal and external audits and inspections + Collaborating with regulatory affairs to ensure compliance with local and international regulations + ... **Job Title:** Batch Release Lead **Grade:** L3 **Hiring manager :** Martin Razo **Location:** Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare… more
- University of Pennsylvania (Philadelphia, PA)
- …(PI), study team and Sponsor/CRO. This position will report directly to the Program Manager and work directly with PIs and clinical research nurses (CRNs). The CRC ... Phase I, II, or III oncology clinical trials. + Assist the Regulatory Coordinator by preparing components of submissions (eg, institutional forms, initial… more
- CSL Behring (King Of Prussia, PA)
- …the guidance of the Publications Director, you will partner with Medical Affairs leaders, Compliance, Clinical, HEOR, and other functions to build efficient ... SOPs, and governance frameworks that ensure scientific integrity and regulatory compliance. You will also drive innovation in publication...provide first line support for junior team members (eg manager and sr manager ) + Lead operational… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …successful candidate will work closely with Clinical Operations, Quality Assurance, Regulatory Affairs , and the Program Management team. Strong cross-functional ... the role. This position will report to the General Manager . **The Role:** + Manage and mentor a diverse...around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma… more