- Parexel (Harrisburg, PA)
- …team members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a **Senior ... Join our dynamic Patient Safety team as a **Senior...(PBRER/PSUR, DSUR, European union renewal, HHE and other Annual Safety /addendum reports) in accordance with regulatory requirements… more
- Parexel (Harrisburg, PA)
- …a plus. Why Join Us: - Work on impactful global programs that directly support patient safety and regulatory compliance. - Collaborate with a diverse, ... Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large,...labeling operations and ready to make a difference in patient safety worldwide, we'd love to hear… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …or issues early. + Collaborate with cross-functional teams (Clinical Ops, Safety , Biostatistics, Programming, Regulatory ). + Manage timelines and deliverables ... True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. ?… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …and medical safety domain knowledge to lead, collaborate, and influence patient safety in activities being performed cross-functionally across the product ... well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care...information to quickly facilitate medically sound decisions related to patient safety . + Management of Medical … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. ? ... Our five Core Values empower us to achieve Our Purpose: ** Patient Focus, Integrity, Innovation, Impact and Empathy.** Learn more about Life at Olympus… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …in clinical studies or medical claims and other secondary data to generate patient safety , treatment efficacy and cost-effectiveness message is essential. + ... True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. ?… more
- Parexel (Harrisburg, PA)
- …site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable ... release), to safeguard the quality of investigator sites (eg patient safety , site quality and compliance with...(DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study… more
- Parexel (Harrisburg, PA)
- …processing for studies including medical review of serious adverse events. - Support regulatory safety reporting activities - Ensure client needs and concerns ... / Medical Director are to: - Provide medical and safety monitoring for assigned projects - Provide medical expertise...this does not include any direct medical advice on patient care or management + Communicate with relevant sponsor… more
- Parexel (Harrisburg, PA)
- …countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, ... for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. +… more
- UPMC (Somerset, PA)
- …basis but is not routinely required. Responsibilities: + Strategizes and carries forward the Patient Safety and Regulatory Plans. + Manages resources to ... UPMC Somerset is seeking a full-time Manager to oversee Regulatory within the...support Patient Safety and Regulatory initiatives. + Assigns … more
