- Parexel (Harrisburg, PA)
- …when applicable. + Ensure document structure, content, and style adheres to FDA /EMA or other appropriate regulatory guidelines, and comply with departmental, ... to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator… more
- US Tech Solutions (Easton, PA)
- …tracker solution to provide real-time visibility of receipt lifecycle status and quality workflow stages. + Develop, maintain, and monitor incoming purchase orders ... corporate systems planning, procurement, master data, pricing and contracting, quality , manufacturing network, supply chain, technical operations, and information… more
- Envista Holdings Corporation (Quakertown, PA)
- …a growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the ... + Collaboration with cross functional teams: mechanical engineering, software engineering, quality engineering, regulatory affairs. + Has developed FMEA, Risk… more
- Pfizer (Collegeville, PA)
- …implement eCOA in clinical studies efficiently, consistently and with the highest quality and lowest regulatory risk.Consideration of technologies allied and ... decision-making, influencing and negotiating skills + Knowledge of clinical research, FDA , ICH, CGP, related regulatory requirements, CDISC **Bonus Points… more
- Sumitomo Pharma (Harrisburg, PA)
- …Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure ... and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products… more
- University of Pennsylvania (Philadelphia, PA)
- …CROs, the FDA , the University of Pennsylvania's CTSRMC, and other regulatory groups. + Coordinate the administration of the investigational product and study ... & consent, visit scheduling, medication administration, data collection, & regulatory compliance with institutional & sponsor requirements. Position is contingent… more
- Norstella (Harrisburg, PA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… 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
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …monitoring operations. * Both working and theoretical knowledge of ICH GCP Guidelines, FDA CFR, PhRMA code, site management, and regulatory compliance. * ... as well as escalating issues related to CRO monitoring quality . While focusing on quality and compliance,...and updates * Provide support for internal audit and regulatory inspection activities as applicable * Review study specific… more
- Charles River Laboratories (Wayne, PA)
- …lab. + Certification/Licensure: None. + _Other:_ Knowledge of cGMP and/or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred, ... With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address...we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science… more