- 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
- 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
- System One (Malvern, PA)
- …approval of product labeling, technical publications, and promotional materials, assuring regulatory requirements are met, safety warnings and precautions are ... Job Title: Director of Regulatory and Medical Affairs Location: Malvern, PA Type:...Work proactively cross-functionally to ensure new product development, new clinical indications, and post market activities comply with internal… more
- West Pharmaceutical Services (Exton, PA)
- …**Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and safety system product ... review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation. + Provide… 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
- 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
- University of Pennsylvania (Philadelphia, PA)
- …and apply regulatory knowledge with the duty to protect research patient safety and data integrity. This position will report administratively to the project ... applicable to the position. Demonstrate accountability for CRC role in maintaining participant safety and data integrity. At close of introductory period, be… 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
- Pfizer (Collegeville, PA)
- …Authority meetings, participates as appropriate. + Reviews and queries safety and efficacy data in support of the clinical data review strategy and ... of quality data and review of emerging clinical data and trends; presents and discusses...working with and solid understanding of related disciplines, eg, Clinical Operations, Safety , Biostatistics, Regulatory ,… more