- Penn Medicine (Philadelphia, PA)
- …consensus on strategies and/or actions necessary to improve compliance to include regulatory , clinical performance, and/or safety outcomes. Develops, ... Surgery Center Quality, Pt Safety and IC PDLH Quality, Pt. Safety and IC Code Committee/Airway Radiation SafetyPerform regulatory functions for assigned… more
- Sumitomo Pharma (Harrisburg, PA)
- …of emerging clinical trends and scientific advancements within Oncology. + Interpret clinical data , evaluate safety and efficacy, and make informed ... create scientifically rigorous and innovative trial protocols. + Oversee clinical trial execution, ensuring quality, patient safety ,...teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies… more
- Charles River Laboratories (Wayne, PA)
- …or more Charles River operations and serves as a member of the Regulatory Affairs and Compliance management team. Provides direction in implementing the Charles ... are accurate, thorough, timely, and provide the correct interpretation of regulatory requirements and corporate policies. ⦁ Maintain a close working relationship… more
- West Pharmaceutical Services (Exton, PA)
- …conformance and compliance + Provide customers with West product compliance information and data as required for regulatory compliance and submissions to North ... Sr. Specialist, Regulatory Affairs, Product Stewardship Requisition ID: 69466 Date:...compliance regulations + Able to comply with the company's safety policy at all times + Able to comply… more
- Penn Medicine (Philadelphia, PA)
- …continuing education and skill validation of clinical staff. Quality, Patient Safety , and Regulatory Affairs: Partnership with the Vice Chair for Quality, ... professional growth of clinical staff. Collaborates with Regulatory and Patient Safety leads and ensures...considered in lieu of total experience Skills and Abilities: CLINICAL : Ability to analyze data , synthesize and… more
- University of Pennsylvania (Philadelphia, PA)
- …aspects of clinical trial coordination including subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The ... University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards. The Clinical Research Coordinator (CRC)...vigilance in patient safety , protocol compliance and data quality. + Communicate clinical trial patient… more
- Lilly (Philadelphia, PA)
- …validation or ensures computer systems employed by contracted third parties meet regulatory data integrity, computer system qualification, and electronic records ... GCP operations in making decisions that relate to patient safety and efficacy data , product quality, including...study protocols to ensure compliance to industry standards and clinical imaging data for accuracy and compliance… more
- Pfizer (Collegeville, PA)
- …presentations regarding strategy and/or data , and may assist with authoring clinical sections of regulatory documents (IB, Annual Reports, IND sections, ... with the Safety Review Plan, performs and documents regular review of individual subject safety data and performs review of cumulative safety data … more
- Pfizer (Collegeville, PA)
- …and interpretation of clinical trials data together with the GDL, Clinical Safety , and Biostatistics. + Serve as technical resource for clinical ... all FIH programs through proof-of concept + Set the clinical data review strategy, ensure quality ...working with and solid understanding of related disciplines, eg, Clinical Operations, Safety , Biostatistics, Regulatory ,… more
- University of Pennsylvania (Philadelphia, PA)
- …aspects of clinical trial coordination including subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The ... University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards. The Clinical Research Coordinator (CRC)...with sponsors and/or CROs. + Show vigilance in patient safety , protocol compliance, and data quality. +… more
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