- Merck (West Point, PA)
- …making internally, and assist with vendor audits as needed. + In regulatory inspections, provide responses to any imaging-related information requests. + Identify ... of the use of imaging in clinical trials for evaluation of efficacy and safety . + Skill in authoring and reviewing imaging documents for clinical trials. + … more
- Merck (West Point, PA)
- …troubleshooting where cross-functional investigation is required. + Technical SME for regulatory questions, audit support, reagent changes / supply issues to provide ... related investigations. + Authoring technical documentation in support of investigation and regulatory responses. + Analytical impact assessors on all QC Lab OPS… more
- ThermoFisher Scientific (Allentown, PA)
- …execution, supporting and building new products that spans study start to final regulatory delivery. This role is responsible for leading Product Managers and UX ... accountable for domain vision, business-case development, roadmap execution, user outcomes, and regulatory compliance (21 CFR Part 11, ICH-GCP, GDPR, HIPAA). This is… more
- J&J Family of Companies (Spring House, PA)
- …initiatives focused on digitally enabling our Preclinical Sciences & Translational Safety (PSTS) laboratory teams worldwide. This leader will drive innovation and ... frameworks to prioritize initiatives, manage risk, and ensure compliance with regulatory and data integrity requirements. + Ensure digital solutions are aligned… more
- University of Pennsylvania (Philadelphia, PA)
- …of adverse events. This coordinator will assist in ensuring patient and data safety , manage samples and related processing, and will be a proactive communicator with ... of the study. + Creates and maintains research data, regulatory files, subject data and patient tracking databases. +...adverse events and reports serious adverse events according to regulatory requirements. + Prepares all documents for IRB review… more
- Jacobs (Philadelphia, PA)
- …management, staff mentorship and leadership, client relationship building, regulatory agency correspondence, data interpretation, and report development. Projects ... with clients and stakeholders. All projects must be delivered with the high safety , compliance, and quality standards expected by both Jacobs and our clients. Our… more
- Penn Medicine (Yardley, PA)
- …follow up care instructions as instructed by provider + Environmental / Safety Accountabilities: Adheres to universal body fluids precautions and infection control ... stock items in appropriate location. CSRs, if applicable as per regulatory guidelines: Maintains medication storage closet inventory and security checks expiration… more
- Nuclear Regulatory Commission (King Of Prussia, PA)
- …These positions are located in the Region I Office, Division of Operating Reactor Safety (DORS), Operations Branch in King of Prussia, PA. The supervisor is Sarah ... assessment. 3. Assisting in the development of operator licensing regulatory policies, recommending improvements, and implementing procedures designed to improve… more
- Langan Engineering, Environmental, Surveying and Landscape… (Philadelphia, PA)
- …supportive work environment for all; prioritizes wellbeing, health, and safety ; encourages volunteerism and philanthropy; offers workplace flexibility, along with ... and beyond. Langan's team is revered in the industry for their regulatory expertise, client advocacy, and providing advanced site remediation solutions on some… more
- Merck (West Point, PA)
- …and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make ... with cross-functional teams and stakeholders to ensure that all platforms meet safety , efficacy, quality, and robust supply standards. + Develop and maintain strong… more