- BeOne Medicines (San Mateo, CA)
- …guidelines. **Essential Functions of the job:** + Oversees the regulatory review process for promotional materials in conformance with local regulatory requirements ... representative on various cross-functional teams, including promotional and medical review committees. Supports direct reports who may attend cross-functional team… more
- AMETEK.Inc (Depew, NY)
- …Key Responsibilities + Participate in daily/weekly shift communication meetings to review line performance (safety, productivity, scrap, customer concerns, 6S). + ... and resolution of CAPAs stemming from customer complaints. + Review and disposition of returned materials associated with customer...Experience in a regulated industry such as medical or pharmaceutical is preferred. + Green Belt in Six Sigma… more
- US Tech Solutions (New Albany, OH)
- …data and reports (eg lot track/trace, incidents). Will also assist with document review and initiate incidents, as well as coordinate and compile general documents ... inspection.; Skills: ; quality assurance or manufacturing experience in the pharmaceutical or medical device industry **Key Responsibilities:** + Provide daily… more
- Amgen (Washington, DC)
- …and compliance expertise to the Global Patient Safety (GPS) organization. + Review adverse event data, literature, and other safety-relevant data for the purpose ... recommendations on safety issues to cross-functional decision-making bodies. + Author and review portions of periodic aggregate safety reports (eg PBRERs, DSURs). +… more
- Cambrex High Point (High Point, NC)
- …that are validatable . Maintain laboratory notebook and perform data review . Maintain lab instrumentation. Conduct method development and optimization on LC/MS ... optimize analytical methods for intermediates and final product. + Maintain and review notebook and data entries. + Write analytical procedures, protocols, reports… more
- Charles River Laboratories (Cleveland, OH)
- …Chemistry Team at our Safety Assessment site located in Cleveland, OH. Perform QC review of study data and perform inspections. Monitor and track common errors and ... accomplished) include, but are not limited to, those listed:_ + Efficiently review all procedures, materials, and results in compliance with applicable regulatory… more
- Contract Pharmacal Corp (Hauppauge, NY)
- …required + Identify and report any non-conformances/discrepancies to management if applicable + Review general SOPs are being met by production + Assist in employee ... air sampling) + Provide additional QA technical support to Coating Department + Review batch record documentation + QMS form issuance as required to production +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …investigator questions, safety monitoring, and ensuring high data quality through data review as part of a cross-functional team + Provide scientific and clinical ... /products + Lead or support clinical development contributions in the preparation/ review of regulatory documents, investigator brochures, and development plans +… more
- Sanofi Group (Morristown, NJ)
- …drug discovery, drug safety, marketing. + Advance the CDP through internal management review . + Leads a clinical subteam to design clinical studies and to create ... with internal SOPs, GCP, ICH guidelines and other regulations. + Review documents supporting clinical development such as Investigator's brochure, regulatory… more
- Mount Sinai Health System (New York, NY)
- …reports as requested for departments and individual researchers + Grants Specialist Review approximately one thousand grant applications per year for all pre-award ... and routing to the Institutional Animal Care and Use Committee, Institutional Review Board, Bio-Safety Officer and Financial Conflict of Interest in Research… more