- Lilly (Indianapolis, IN)
- …ensuring regulatory compliance in creative production, including OPDP and FDA submissions. + Critical thinking skills; comfortable with ambiguity. + Team ... for OPDP submission processes for consumer campaign materials, ensuring regulatory compliance from development through execution. Campaign Execution + Lead… 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) ... and physicians in maintaining a patient/customer focus, supports the delivery of high- quality care, shares a passion for patient and customer centered care, and… more
- Penn Medicine (Berwyn, PA)
- …/ Regulatory + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... and physicians in maintaining a patient/customer focus, supports the delivery of high- quality care, shares a passion for patient and customer centered care, and… 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) ... and physicians in maintaining a patient/customer focus, supports the delivery of high quality care, shares a passion for patient and customer centered care, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …qualification of thermal protection systems, collaborating with internal stakeholders (eg, Quality , Regulatory , Supply Chain, Analytical Ops.) and external ... + Experience with temperature-controlled shipping container qualification and the corresponding product quality testing. + Strong understanding of FDA , EMA, and… more
- Caris Life Sciences (Tempe, AZ)
- …trial master files. + Contribute to and/or lead process improvements. + Socialize regulatory requirements and standards (eg, FDA , ICH GCP, ISO 20916, IVDR, ... Companion Diagnostics Specialist will collaborate with Clinical Research, QA, Regulatory Affairs and other study stakeholders to coordinate study-related activities… more
- Ascendis Pharma (Palo Alto, CA)
- …(Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Working knowledge of FDA safety regulations, ICH ... the oversight of the PV Vendor processing ICSRs for Ascendis Products. + Performs Quality Checks of processed ICSRs and provides feedback to PV Vendor as applicable.… more
- Penn Medicine (Cherry Hill, NJ)
- … Regulatory : . Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) ... and physicians in maintaining a patient/customer focus, supports the delivery of high- quality care, shares a passion for patient and customer centered care, and… 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) ... and physicians in maintaining a patient/customer focus, supports the delivery of high- quality care, shares a passion for patient and customer centered care, and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …of commercial products and lifecycle management. + Collaborate closely with R&D, Quality , Regulatory , Procurement, and External Supply Teams to support seamless ... drug delivery devices. + Engage actively with Product Operations, Quality , Regulatory , and External CMO Operations &...and manufacturing. + Strong understanding of design control and regulatory requirements ( FDA , EMA, ISO, USP) for… more
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