- Cardinal Health (Harrisburg, PA)
- …hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas, ... of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs. **Responsibilities:** + Collaborate across multiple functions and… more
- Penn Medicine (Yardley, PA)
- …/ Regulatory : Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) ... stock items in appropriate location. CSRs, if applicable as per regulatory guidelines: Maintains medication storage closet inventory and security checks expiration… more
- Penn Medicine (Philadelphia, PA)
- … Regulatory : + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) ... items in appropriate location. + CSRs, if applicable as per regulatory guidelines: Maintains medication storage closet inventory and security; checks expiration… more
- Penn Medicine (Philadelphia, PA)
- …Board of Pharmacy, USP <795>, <797>, and <800>, the Joint Commission, FDA , and OSHA. Assists leadership in maintaining employee education and learning files. ... professional development of staff. -Works with pharmacy leadership to maintain regulatory compliance for education before, during and after surveys and audits… more
- Penn Medicine (West Chester, PA)
- …/ Regulatory : Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) ... stock items in appropriate location. CSRs, if applicable as per regulatory guidelines: Maintains medication storage closet inventory and security; checks expiration… more
- Penn Medicine (Philadelphia, PA)
- …Continuously improve unit/department operations to maintain and exceed internal/external regulatory compliance and achieve clinical excellence. Participates in and ... to capture patient safety trends.Supports the Nurse Manager in ensuring regulatory compliance:(In partnership with Leadership Team) Ensures compliance with all… 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
- University of Pennsylvania (Philadelphia, PA)
- …mission. Prepare draft PS-IDE applications for faculty review and submission to FDA . Draft components of clinical protocols and informed consents documents in ... collaboration with faculty. + Regulatory -Financial-Training/Continuing Education: Negotiate clinical trial agreements and budgets; conduct study initiation;… more
- Sumitomo Pharma (Harrisburg, PA)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… 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