- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions to Health ... for QA activities for internal and external oversight.Manage and/ or guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs,… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …(User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the assessment ... medications when neededAddresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as neededStudy-specific subject… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes associated with legal and financial requirements including handling internal audit . Work closely with IT regarding implementation and utilization of new ... and resolving matters of confidentiality. Coordinating a budget planning and review meeting with Finance Business Partner, Function Head and stakeholders. Partner… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …document management and data integrity. The incumbent is responsible for authoring, review and manage the development of internal procedures to ensure adherence to ... and regulatory requirements for GMP area. Responsible for the creation and review Quality Assurance Agreements with contract organization and to manages a Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and forecasting for commercial and IMP relevant activities and QA batch review and release process as necessary.Complaint and Recall Programs Establishment: Manages ... external stakeholders to complete deviations in a timely manner.Development and Review of Standards and Procedures (SOPs) and Training Activities: Responsible for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strategy, comparability plans and data governance initiativesProvide critical input and review for validation master plans, PPQ and comparability protocols and ... reportsServe as reviewer /author of a variety CMC sections or regulatory submissions,...and contributes to follow-up actions as part of an audit response teamDevelop and align a variety of process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Successfully support the implementation, execution, and improvement of the internal audit process.Support the planning and execution of internal audits for all ... quality system areas for the manufacturing site; write audit reports, issue audit observations and follow-through...team, ad hoc, for activities such as annual product review , site risk register, or internal quality agreements.Develops and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Standard Operating Procedures (SOPs) for equipment operation.Conduct regular reviews of system audit trails / periodic review to ensure data integrity and ... compliance.Manage equipment access rights and perform periodic reviews to maintain security protocols.Maintain high level of familiarity with GMPs, CFR Part 11, and current regulatory guidelines related to instrument calibration and CSV (eg, GAMP 5, USP… 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
- Zelis (Morristown, NJ)
- Position Overview: At Zelis, the Itemized Bill Review Facility Reviewer is responsible for analyzing facility inpatient and outpatient claims for Health Plans ... overall claims progression + Complete claims processing after the Clinical Bill Review and Audit analysis is completed. + Assist in appeals process as necessary… more
- City of New York (New York, NY)
- …participate in all medical record reviews /audits following established ACS medical audit protocols. The Nurse Reviewer will also conduct targeted, unannounced ... and initiatives that support best case practice agency wide. The Medical Review Authorization and Monitoring Unit (MRAM) reviews foster care medical records and… more
- Zelis (Morristown, NJ)
- Position Overview: The Nurse Reviewer is primarily responsible for conducting post-service, pre or post payment in-depth claim reviews based on accepted medical ... billing and coding rules, plan policy exclusions, and payment errors/overpayments. Conduct review of facility and outpatient bills as it compares with medical… 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)
- …accuracy of benefits issued and compare to State Quality Control error findings or to the month under review in the EQAS audit . - Audit for the EQAS QC on 16 ... as a Quality Control Case Reviewers, who will: - Review POS, HRA One Viewer of imaged/scanned documents, Welfare...in Order to obtain critical information. Complete a desk audit to secure documentation pertinent to quality control eligibility… more
- City of New York (New York, NY)
- …legal and federal, state and city regulatory requirements. The Process Evaluation Review Team (PERT) is tasked with aggressively monitoring program compliance with ... Assurance & Fiscal Integrity (OQA&FI) / The Process Evaluation Review Team (PERT) is recruiting for (2) one Principal...(Reynolds, Lovely H., MKB, Dajour, Davila, Brown, etc.). Convert audit findings into reports that will be presented to… 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
- Citigroup (New York, NY)
- …product line at the regional or country level including a portion of the annual audit plan + Review and approves the Business Monitoring Quarterly summary and ... The Audit Manager is an intermediate level role responsible for managing...serve as lead reviewer for various tasks + Collaborate with teams across the business… more
