- Penn Medicine (Philadelphia, PA)
- …and brings groups to consensus on strategies and/or actions necessary to improve compliance to include regulatory , clinical performance, and/or safety ... & procedures & regulatory requirementsDevelops, documents in, and maintains regulatory related databases necessary to track compliance activities and… more
- WellSpan Health (York, PA)
- …hours biweekly) Weekdays, daytime hours and some evenings **General Summary** Coordinates clinical research activities and compliance to study requirements, ... Assists the medical investigators in achieving the objectives of clinical research studies and supports ongoing patient...less experienced personnel and advises others to insure that research is conducted safely and in compliance … more
- Penn Medicine (Philadelphia, PA)
- …discuss and address regulatory issues. Ensure compliance with regulatory policies and standards, supporting clinical integration by standardizing ... ensure regulatory readiness. Provide strategic consultation and coordination for regulatory compliance across Penn Medicine. Convene and chair system-wide … more
- Merck (North Wales, PA)
- … Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, Pharmaceutical ... content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in regulatory ...Regulatory Affairs, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance , … more
- Sumitomo Pharma (Harrisburg, PA)
- … (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre- clinical research , Medical Affairs and Commercial ... budget for Oncology clinical development activities. + Partner with Translational Research , Regulatory Affairs, Clinical Operations, and Medical Affairs… more
- Geisinger (Danville, PA)
- … Administration, to ensure compliance with ethical standards, contractual and regulatory requirements for clinical research . + Oversee the evaluation ... provide guidance and updates to new and active pediatric clinical research initiatives. + Participate in key..., Office of Sponsored Projects, and Finance and navigating regulatory or other research requirements. + Experience… more
- West Pharmaceutical Services (Exton, PA)
- …customers with West product compliance information and data as required for regulatory compliance and submissions to North America, Europe, and Rest of World ... **Job Summary** The Sr. Specialist, Regulatory Affairs evaluates supplier regulatory declarations for compliance , authors and maintains material … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Management, Quality and Regulatory Affairs, and investigational sites. + Ensure clinical studies are conducted in compliance with relevant Olympus policies, ... Digital and AI is a strategic leader within the Clinical Research leadership team, reporting directly to...market engagement. + Continuously monitor and interpret evolving global clinical and regulatory landscapes, as well as… more
- Sumitomo Pharma (Harrisburg, PA)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research , and development to bring novel therapies to patients sooner. For more… more
- Merck (Upper Gwynedd, PA)
- …Management Process, Medical Research , Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance , Regulatory Compliance {+ 5 ... The Senior Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance of a supervisor, the Senior Director… more