- 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
- Charles River Laboratories (Ashland, OH)
- …or basic knowledge of data collection systems. Introduction to protocol development, regulatory compliance and internal systems utilized in the conduct of a study. ... of Project Scientist. + Interact regularly with sponsors: send amendments and regulatory forms for signature, respond to sponsor-requests for information and tables,… more
- Penn Medicine (West Reading, 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
- Radformation (New York, NY)
- …devices, so you will ensure that testing provides products that are high quality , supporting patient safety and regulatory compliance. With your technical ... faster, safer, and more consistently, so patients everywhere can receive the same high- quality care. Our software focuses on three key areas: * Time savings through… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …products by closely working with MTP internal colleagues in various functions ( Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, ... + Collaborates effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs, Finance, etc. of Tanabe Pharma… more
- HCA Healthcare (Dallas, TX)
- …employee conduct. + Contribute to achievement of department goals for service, quality , regulatory compliance, financial performance, and patient and employee ... and non-technical resources and operations to meet organizational and regulatory requirements. + Execute programs for staff hiring,orientation, training, competency… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …regulatory requirements, operational efficiency, and alignment with corporate quality objectives. The position drives governance, technology enablement, and ... within the Learning Center of Excellence (CoE) under Global Quality . This role is responsible for overseeing the end-to-end...teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.).… more