- Sanofi Group (Swiftwater, PA)
- …internal and external audits and inspections + Collaborating with regulatory affairs to ensure compliance with local and international regulations + ... + Overseeing the batch release process to ensure compliance with regulatory requirements and company standards + Overseeing review and approval of… more
- University of Pennsylvania (Philadelphia, PA)
- …Phase I, II, or III oncology clinical trials. + Assist the Regulatory Coordinator by preparing components of submissions (eg, institutional forms, initial ... responses to IRB stipulations, queries and concerns; remain aware of the regulatory statuses for assigned protocols. + Lead or contribute to Informed Consent… more
- Merck (North Wales, PA)
- …adherence, and outcomes while maintaining compliance with the highest ethical and regulatory standards. The Director will collaborate closely with the US patient ... to include alignment with Global Pharmaceuticals policy and Global Medical and Scientific affairs in support of IBD launch + Identify key elements of a patient… more
- J&J Family of Companies (Spring House, PA)
- …Leadership, Medicines and Device Development and Regulation, Presentation Design, Regulatory Affairs Management, Relationship Building, Research Documents, ... analysis and reporting of trial results; and interactions with global regulatory agencies. ESSENTIAL FUNCTIONS: (CORE Responsibilities) . Perform medical monitoring… more
- University of Pennsylvania (Philadelphia, PA)
- …UPHS, PSOM and Department administrative units, as well as national and international affiliations. + Maintain discretion and confidentiality at all times in the ... personnel when necessary. + Manage travel and reimbursements for national and international meetings and invited lectures; manage and process licenses and expenses… more
- University of Pennsylvania (Philadelphia, PA)
- …and discrimination. Our faculty have held presidential appointments on federal regulatory commissions, held research appointments and fellowships in government and ... Research Initiative (PDRI) projects focus on various aspects of international development including education, health, governance, environment, gender, urbanization… 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 ... trackers, SOPs, and governance frameworks that ensure scientific integrity and regulatory compliance. You will also drive innovation in publication metrics and… more
- University of Pennsylvania (Philadelphia, PA)
- …coordinating activities in single center and multicenter studies (including international sites), quality control, and assisting with grant applications when ... QC; study close out activities). + Develop, create and review regulatory submission and study documents/tools, including protocols, consents, annual reports, source… 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 ... to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health… more
- University of Pennsylvania (Philadelphia, PA)
- …Project Manager A/B will responsible for oversight, day-to-day management, execution and regulatory compliance of complex human subject research carried out in the ... coordinating activities in single center and/or multicenter studies (including international sites), assisting with quality control and analysis of qualitative… more