- Sanofi Group (Swiftwater, PA)
- …team to meet goals and priorities. Assures operations are conducted in compliance with regulatory authorities. Assures operations are conducted in compliance ... for regulatory and internal inspections + Assures that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies + Supports SGS… more
- Sanofi Group (Swiftwater, PA)
- …teams accelerate progress. This position will be focused on assessing GCP Compliance in clinical related activities and supporting the Quality Management System to ... get started? **Main Responsibilities:** + Independently manages and performs compliance audits of Contract Research Organizations (CRO), Process Project-related and… more
- NTT America, Inc. (Pittsburgh, PA)
- …projects. * Minimum 2 years of experience with project governance frameworks and managing compliance with industry standards such as GxP, FDA 21 CFR Part 11, ... role will involve managing cross-functional teams, aligning projects with compliance frameworks, and optimizing delivery performance in regulated settings. **Minimum… more
- Fujifilm (Harrisburg, PA)
- …process change to improve efficiency and customer satisfaction. + Ensure compliance with all applicable requirements of the company's quality management system. ... HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties inherent in the position… more
- University of Pennsylvania (Philadelphia, PA)
- …with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is ... processing/handling. The CRC will demonstrate vigilance in patient safety, protocol compliance , and data quality, and will participate in data organization for… more
- Penn Medicine (Philadelphia, PA)
- …and administrative functions of their individual laboratory section(s); ensure compliance with institutional and laboratory policies and procedures; evaluate and ... functions with residents/fellows, Medical Laboratory Science and other students.Regulatory Compliance : Works with the Division's Quality Assurance manager in… more
- Penn Medicine (Philadelphia, PA)
- …improve unit/department operations to maintain and exceed internal/external regulatory compliance and achieve clinical excellence. Participates in and supports ... to capture patient safety trends.Supports the Nurse Manager in ensuring regulatory compliance :(In partnership with Leadership Team) Ensures compliance with all… more
- Penn Medicine (Philadelphia, PA)
- …and administrative functions of their individual laboratory section(s); ensure compliance with institutional and laboratory policies and procedures; evaluate and ... functions with residents/fellows, Medical Laboratory Science and other students. **Regulatory Compliance ** : + Works with the Division's Quality Assurance manager in… more
- University of Pennsylvania (Philadelphia, PA)
- …to regulatory boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Job Description Research coordinator work ... regulatory boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Duties: Clinical ResearchCoordinator B:… more
- Sumitomo Pharma (Harrisburg, PA)
- …Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more