- University of Pennsylvania (Philadelphia, PA)
- …and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing ... Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory Affairs Specialist-CC will, with minimal supervision, prepare… more
- Kedplasma (Altoona, PA)
- …Responsible for registering and screening donors under the direction of the Center Manager . Operates within the scope of EU Guidance on Good Manufacturing Practice ... and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...donors. + Assists qualified donors in completing the screening process . + Assesses the self-administered health history, refers donors… more
- Kelly Services (Malvern, PA)
- …regulatory compliance and technical feasibility of proposed changes. + Serve as project manager for the change process and provide coordination to ensure timely ... Serve as a SME during internal and external regulatory audits including FDA , EMA . + Extract process data from SCADA and Delta-V servers for use in databases… more
- CSL Plasma (Philadelphia, PA)
- **The Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance ... the development and implementation of continuous improvement plans + Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during… more
- Kedplasma (Pittston, PA)
- …suitability and handling donor reactions under the direction of the Center Manager , Physician Substitute Supervisor and Center Medical Director. Operates within the ... scope of EU Guidance on Good Manufacturing Practices and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...suitability. + Promotes donor education of the plasma donation process to encourage a positive donor experience. + Answers… more
- Highmark Health (Pittsburgh, PA)
- …and testing processes in partnership with the pharmacy benefits manager . The successful candidate will possess excellent communication, analytical, and ... a fast-paced and collaborative environment. **ESSENTIAL RESPONSIBILITIES** + Monitor FDA -approvals, drug manufacturer pipelines, assess drug utilization reports, and… more
- Bayer (Philadelphia, PA)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... and collaboration with territory cross-functional stakeholders (ie Area General Manager , Area Business Unit team, Field DGOS, etc.) as...or equivalent experience is preferred; + Working knowledge of FDA , OIG requirements; + A minimum of 1 year… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …+ Demonstrates knowledge and experience working with: + Various regulations (HIPPA, EU-MDR, FDA 21 CFR Part 803, 806, 820) + Various standards (GCP, ISO 13485, ... ISO 14971) + Regulatory filings ( FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs) +...with disabilities are provided reasonable accommodations for the hiring process . If reasonable accommodation is needed, please contact ###@olympus.com.… more
- Penn Medicine (Philadelphia, PA)
- …Full-Time** **Job Summary:** The Patient Services Coordinator (PSC) assists the manager and/or physicians in maintaining a patient/customer focus, supports the ... expectations are communicated and met. In the absence of the manager , the PSC may take on additional responsibilities. **Accountabilities:** **Coordinator… more
- Penn Medicine (Philadelphia, PA)
- …- Full Time Summary: + The Patient Services Coordinator (PSC) assists the manager and/or physicians in maintaining a patient/customer focus, supports the delivery of ... performance expectations are communicated and met. In the absence of the manager , the PSC may take on additional responsibilities. Responsibilities: + **Coordinator… more