- Daiichi Sankyo, Inc. (Bernards, NJ)
- … audit process, to ensure information is documented and reported timely.Folder Audit includes: Review HCP Engagements that are considered closed according to ... and Department Head a monthly pass/fail report for performance managementMonthly full file audit includes: Review that all documents are uploaded and in the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …review & material release in SAP for In-house reagents.Support Floor Spot-check, audit trail review .Strive to reduce non-conformances in supported areas by ... provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices… more
- Aequor (South San Francisco, CA)
- Job Title: Senior Taxonomist - Content Review & Management Location: Onsite - South San Francisco (SSF) or Remote Contract Type: 6-Month Contract (with potential ... We are seeking an experienced and strategic Senior Taxonomist to support our Content Review and Management team. This is a 6-month contract role with the possibility… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received ... transfer of PV Business in case of Product Divestment. Collaborate with DSI audit groups to ensure comprehensive auditing of Business Partners as required to assure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality Indicators (KQIs). ... Affairs team, ensuring collaboration with other GxP QA functions (eg, GMP/IMP QA, Audit and Compliance, QMS QA, Development QA, and PVQA) to address GxP-related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Aggregate Spend data and timeliness associated with the reports including the 100% audit of all HCP engagements. Additionally, this position will be responsible for ... with the approved budgets.- Weekly touch base with 3rd party planners to review all aspects of the meeting.- Identifies training sessions for 3rd party vendor… more
- Eisai, Inc (Nutley, NJ)
- …use of funds, and economic trends. Additionally, this individual will review cash requirements, plans and prepare short-term investments/borrowings to optimize daily ... coverage) for a marketed product across all relevant insurance lines; Lead audit calculations for premium adjustments; Manage the end-to-end process of claim… more
- Aequor (Thousand Oaks, CA)
- …with assigned business partners. Case processing point of contact for audit related activities related to case processing. Accountable for measuring quality ... to FDA, EMA and Business Partners. Key Activities - Perform case review . Support the development and delivery of convention-related training material. Ensure… more
- Merck & Co. (North Wales, PA)
- …safety guidelines and company policies and procedures.-May assist with the preparation or review of relevant SOPs or policies relevant to GRACS or partnering our ... Awareness, Detail-Oriented, Global Compliance, Good Clinical Practice (GCP), IS Audit , Issue Management, Knowledge Management, Management Process, Marketing Compliance,… more
- Merck & Co. (Lower Gwynedd, PA)
- …as subject matter expert with internal or external teams and during audit on serology methods and platforms (eg, Luminex) and associated lab ... automation-Accountability for generated data. -May review data generated by others-Understand and apply regulatory/compliance/scientific requirements relative to… more
