- Bristol Myers Squibb (Indianapolis, IN)
- …cGMP regulations and guidance. + Knowledge and proven experience in FDA , EMA, or other regulatory authority. + Demonstrated leadership, interpersonal, communication, ... + US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to...160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays… more
- ZOLL Medical Corporation (Boston, MA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... and billing requirements. You will also be working closely with an Associate Territory Manager (ATM) to help sell and grow the ZOLL CMS products. This individual… more
- Taiho Oncology (Princeton, NJ)
- …Objectives: + Coordinates cross functional study team meetings and supports study manager with meeting minutes for assigned studies. + Updates internal study ... site-related documentation, and inspection readiness. + Collaborates closely with study manager to align expectations and study priorities for support. + Manages… more
- HCA Healthcare (Port Charlotte, FL)
- …+ Communicates all protocol-related issues to appropriate study colleagues or manager + Attends study specific on site meetings, investigator meetings, conference ... Apprises principal investigator, Research Operations Director and Regional Site Manager of all study specific medical issues for guidance...medical issues for guidance + Assists sponsor and US FDA audit teams + Reviews and responds to any… more
- Conagra Brands (Indianapolis, IN)
- …You will need a sound knowledge of product types, department rules, GMP's, FDA , OSHA, Safety, Quality and technical skills relative to plant equipment. You are ... a professional manner. You will report to the Maintenance Manager and work at our Indianapolis Bakery plant. You...You will coach maintenance employees and, if needed, involve manager for support. + You will guide BDA, MPS,… more
- University of Pennsylvania (Philadelphia, PA)
- …various sponsors. This position will report directly to the Airways Program Manager and work directly with Physician Investigators ("PI") on clinical research ... with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is… more
- Trinity Health (Maywood, IL)
- …and repair of clinical equipment as assigned by Clinical Engineering (CE) Manager . Resolves sensitive or complex problems with supervision. Orders parts and ... test equipment and spare equipment parts to the CE Manager . Responsible for coordinating repairs with vendors and users...understanding of OSHA, NFPA, The Joint Commission, , EOC, FDA and other specific regulations and standards pertaining to… more
- PCI Pharma Services (Madison, WI)
- …+ Establish all required preventive maintenance plans utilizing the Regulatory Asset Manager (RAM) System. + Ensure preventive maintenance work plans are current, ... CAPAs completely on time. + In collaboration with Facility Manager , ensure technicians are adequately trained on site facility...of hazardous chemicals and their disposal, OSHA, EPA, and FDA requirements. + Requires in-depth knowledge of cGMPs as… more
- Penn Medicine (West Chester, PA)
- …**Job Summary:** The Clinical Services Associates (CSA) assists the practice manager and physicians in maintaining a patient/customer focus, supports the delivery ... patients regarding patient flow and wait times - keeps manager aware of potential issues as they arise. Issues...federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) Flexible and… more
- Penn Medicine (Somers Point, NJ)
- …. Communicates with patients regarding patient flow and wait times - keeps manager aware of potential issues as they arise. . Issues referrals and obtains ... federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) . Flexible...issues and timely reports problems related to volume to manager . . Follow established downtime procedures for registration .… more