- Guthrie (PA)
- …Alignment: Support quality improvement teams in aligning efforts with patient safety, clinical excellence, and regulatory compliance initiatives Other Duties + ... departmental leadership, work collaboratively with operational leadership to shape clinical and operational initiatives, , lead cross-functional teams for effective… more
- IQVIA (Philadelphia, PA)
- …a specific CDM task (eg, Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where ... ability to apply them in practice. + Knowledge of Good Clinical Practices and relevant regulatory guidelines. + Comprehensive understanding of clinical drug… more
- Guthrie (Sayre, PA)
- …to Nursing, Imaging, Pharmacy, Patient Safety, Clinical Data Informatics, Clinical Systems, Case Management, Regulatory Compliance, Population Health, Value ... + Maintain thorough understanding of the requirements associated with regulatory , quality reporting, and national quality standards/strategies. Responsible for the… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …(T0 - T1) or early development (phase 1) assets either within Medical Affairs, Regulatory Affairs, or Clinical Development is preferred. + Minimum of 7+ years ... and strong competency with the US healthcare system and regulatory landscape is required for this role. + Stay...closely with other key functions, including regional medical leads, clinical development, global value and real-world evidence, US and… more
- Globus Medical, Inc. (Audubon, PA)
- …of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and ... as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for...the completion of IDE and PMA submissions for IDE clinical trials + Helps to prepare PMA packages, including… more
- Globus Medical, Inc. (Audubon, PA)
- …of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and ... can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance for… more
- St. Luke's University Health Network (Allentown, PA)
- …multiple departments, leading projects, tracking ROI. Minimum 3 years' experience in non- clinical operations - collaborating with regulatory , IT, IT Security, ... internal departments - Information Technology, Management Engineering, Operations, Finance, Clinical Quality, etc. - to ensure alignment of recommended solutions.… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- … trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be ... + ** Regulatory Authority Engagement:** Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing any… more
- IQVIA (Wayne, PA)
- **Overview** IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the medical product lifecycle. The ... and includes qualitative (eg, interviews, focus groups), quantitative (eg, clinical outcome assessments [COAs]/patient-reported outcomes [PROs], preference research) and… 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