- Merck & Co. (Rahway, NJ)
- …review of batch documentation and deviation investigations.Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint ... management, change control oversight, metric review , and review of annual product reviews. This also includes providing support to build effective quality… more
- Eisai, Inc (Nutley, NJ)
- …track KPIs.Define critical processes and manage recovery testing.Regularly review adherence to standards.Oversee regional security vendors.Prioritize risk-based ... compliance issue resolution.Report compliance risk levels to key stakeholders.Coordinate audit readiness and resolution.Align IT compliance budget with risk appetite… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …design, participate in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review - Conducts clinical data review per Integrated Data Review ... medications when needed- Addresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as needed- Study-specific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …input into study protocol profiles, final protocols and amendments.Lead document review & coordination for the protocol and amendments. Additional medical writing ... bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …input into study protocol profiles, final protocols and amendmentsLead document review and coordination for the protocol and amendments. Additional medical writing ... bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …compliance, and global Quality expectations. Partner with global Quality departments to review global policies, inspections and audit CAPAs, and vendor ... or qualification of global GxP and Non-GxP computer systems.Create and review various validation documentation such as Validation Plans, Protocols (IQ/OQ/PQ), Test… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as the overall process.Accountable for the maintenance, and peer review of key Daiichi Sankyo procedural documents (SOPs/SOIs), including external data ... applicable Daiichi Sankyo and regulatory requirements.Supports any external data related audit requests for assigned DS Programs / Studies; communicates to Vendors… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analytical approaches (eg, identification of outliers to focus monitoring/ audit activities).Responsibilities Compliance Monitoring Responsible for activities related ... all monitoring activities and results.Conduct field-based (live) monitoring, records review , and data-based monitoringData analytics Maintain/revise current monitoring tools/reports,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to dive into different functions of GMP QA Department such as Audit , Quality Management System, Pharma Product, External Supplier Management and Strategical ... collaboration for local SOP's and SOI's.Support Quality personnel as part of audit activities of manufacturing, facility, and quality controls areas and operations.… more
- Insmed Incorporated (Bridgewater, NJ)
- …during regulatory agency inspections and vendor audits.Ensure that a risk-based audit plan is developed, designed and implemented, and that the activities ... Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports along with reviewing and monitoring QE's/CAPAs.CQA representative for… more
- Novo Nordisk Inc. (Stamford, CT)
- …retention targets Participates in the preparation, conduct and follow-up of audit and inspection activities, collaborating with relevant internal and external ... good standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records.; May be required to work company holidays and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …expectations Aligns business teams to timelines, deliverables and expectations. Drives review and approval process with relevant leadership teams Works closely with ... sales in accordance with HQ timelines Own the internal and external audit relationship Assist in the development and improvement of operational systems, processes… more
- Tris Pharma (Monmouth Junction, NJ)
- …Drug Safety activities including, but not limited to: safety data review , signal detection, risk communication including safety information updates, potential risks ... reconciliation of safety data in pharmacovigilance and clinical trial databases Ensures audit and inspection readiness of Drug Safety team at all times; Ensures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …tactics is made available to the field-based Medical Liaison Associate Directors/Directors Review and audit direct report expense reports. Manage direct reports ... sites; ensuring effective coordination and facilitation of studies to ensure timely review , initiation, and completion, as well as publication of study results.… more
- City of New York (New York, NY)
- …Services Program (HCSP) is recruiting for one (1) Accountant II, to function as an Audit Reviewer in the Home Care Contract Management Services Unit, who will: - ... Review audit reports for accuracy and compliance... Review audit reports for accuracy and compliance with prescribed ...Interface with CPA firms to ensure correct resolution of audit discrepancies, review requests for extension of… more
- HSS (New York, NY)
- …our Mission, you too can be part of our transformation across the enterprise. DRG Reviewer Full-Time The DRG Reviewer reports to the Director of Coding, HIM ... (Health Information Management). The DRG Reviewer oversees DRG accuracy. The DRG Reviewer ...+ Monitors coding and documentation accuracy. + Conducts retrospective review of the medical record to increase accuracy, clarity,… more
- City of New York (New York, NY)
- …required, for sample selection revision. Collect all policies and procedures necessary for the audit review and share documents with the Quality Control Case ... Reviewer , who will: - Conduct the preliminary monthly review of MICSA and HCSP cases selected from a...Control Case Review Supervisor. - Prepare case review summaries related to audit findings to… more
- City of New York (New York, NY)
- …(DSS) and Department of Homeless Services (DHS). Within DSS-AO, the Process Evaluation Review Team (PERT) was created as an independent unit within the Office of ... compliance and foster uniform interpretation/application of policy. PERT auditors review cases, monitor application and recertification interviews, check for… more
- City of New York (New York, NY)
- …issued and compares to State Quality Control error findings or to the month under review in the EQAS audit . - Secure collateral information to verify the ... who will: - Be responsible for the EQAS QC audit on 16 cases each month randomly selected from...information in order to determine if discrepancies exist. - Review POS, HRA One Viewer of imaged/scanned documents, Welfare… more
- City of New York (New York, NY)
- …THE PRINCIPAL ADMINISTRATIVE ASSOCIATE CIVIL SERVICE TITLE. The Process Evaluation Review Team (PERT) is tasked with aggressively monitoring program compliance with ... and agreements (Reynolds, Lovely H., MKB, Dajour, Davila, Brown, etc). Convert audit findings into reports that is presented to Family Independence Administration… more
