- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and WHO Drug Coding dictionaries) including dictionary support documentation . Collaborates cross-functionally with the Medical, Clinical Development, Clinical ... of the coded data and adherence to regulatory requirements. Develops and maintains documentation of items on medical coding, including but not limited to Daiichi… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with ... the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to...new and updated Core Data Sheets, EU and US Documentation : As the project lead, Independently or through direction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with ... the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to...new and updated Core Data Sheets, EU and US Documentation : As the project lead, Independently or through direction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …EU. Preparation of updated Core Data Sheets, and EU and US Documentation : Independently manages, prepares and implements regulatory documents (eg, USPI, annotated ... CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports ... PV relevant contracts. Oversee and set standards for PV contract management. Review contribute to revision of DSI contracts (eg development, license, distribution… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Under the direction of the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and modify Structured Product ... listing, track and archive affiliate labeling for global products and review proposed labeling from affiliates. Responsibilities Provide Regulatory support in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents.Manage external vendors and ensure accurate and high-quality deliverables. Ensure documentation and consistent maintenance of code, logs and output within ... as per CDISC SDTMIG. Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams. Develop,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position oversees the creation of SAE Flow Plans and may perform final review . This position provides input on electronic data capture (EDC) Safety report outputs, ... and provides input to SOPs, SOIs, and process guides.Clinical Study Start-Up Documentation : Reviews all clinical study protocols to ensure consistency in safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management and to external party for the collaboration program. Participate in the review and analysis of quarterly financial results against plan and monitor key ... management.Special Projects/Change Management - Create and maintain up-to-date process documentation for all tasks; recommend and implement process improvements, as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development project meetings. Conduct completeness, scientific accuracy, and ease of review of the submissions. Provides guidance to peers and cross-functional team ... Joint-GPT as applicable.Supervises the identification and compilation of required documentation for submission. Prioritizes workload as necessary.Keeps current with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external vendors/partners to execute responsibilities.- Responsible for review , approvals, categorizing, prioritizing, of change requests.- Analyze Service ... team members maintain alignment to standards, following GxP guidelines meeting documentation needs in support of all internal and external audits. Qualifications:… more
- HEPCO, Inc. (Franklin, NJ)
- …responsible for tracking program progress, reporting on production, updating program documentation , and ensuring effective use of program resources. This role ... and maintain all program manuals, guidelines, FAQs, and internal/external documents Review and analyze pipeline data and reporting Track, investigate, and resolve… more
- City of New York (New York, NY)
- … Reviewers who will: Facilitate participant intake process, including collection and review of documentation required to obtain approval in education and ... One Viewer system, including data entry and retrieval on computerized systems. - Review records processed by the unit, identifying errors, and indicating need for… more
- City of New York (New York, NY)
- …care (NAMI-Net Available Monthly Income) if institutionalized. - Interview and/or review documentation submitted by applicants/recipients (A/R) or authorized ... seeking (1) Eligibility Specialist II to function as Case Reviewer . The Case Reviewer will: - Respond...to determine eligibility for Medicaid. - Conduct a comprehensive review of applications including financial and legal documentation… more
- City of New York (New York, NY)
- … for both sustainability and resiliency; LEED compliance strategies; and certification documentation . The Sr. Design Reviewer will also be responsible for ... Department of Design & Construction, Public Buildings Division seeks a Sr. Design Reviewer to join the Sustainability Unit. The selected candidate will serve as one… more
- City of New York (New York, NY)
- …Quality Control Case Reviewer , who will: - Conduct the preliminary monthly review of MICSA and HCSP cases selected from a sample of activated, recertified, ... from the State On-Line Query (SOLQ) databases. - Ensure the accuracy of the review sample by conducting preliminary WMS inquiries and case review ; utilize… more
- City of New York (New York, NY)
- …care (NAMI-Net Available Monthly Income) if institutionalized. - Interview and/or review documentation submitted by applicants/recipients (A/R) or authorized ... representatives, to determine eligibility for Medicaid. - Conduct a comprehensive review of applications including financial and legal documentation , as well as… more
- City of New York (New York, NY)
- …third-party contacts to clarify and identify any variances, discrepancies or inadequate documentation discovered during the review of State Quality Control ... II to function as a Quality Control Case Reviewers, who will: - Review POS, HRA One Viewer of imaged/scanned documents, Welfare Management System (WMS) data… more
- VNS Health (Manhattan, NY)
- …with high volume providers for compliance with HEDIS/QARR standards. Evaluates documentation discrepancies identified during initial review and advises on ... healthcare facilities on the retrieval of medical records for review and abstraction pertaining to HEDIS/QARR and other focused...corrective actions as appropriate. Reviews and enters documentation findings into a database. + Manages and organizes… more
- City of New York (New York, NY)
- …by the New York State Office of Temporary and Disability Assistance (NYSOTDA). Review the corrective action memorandums and supporting documentation on State ... Associate III to function as a Quality Control Case Review Supervisor who will: - Supervise and provide guidance...Monitor the preparation and submission of detailed correspondence and documentation to be sent to New York State Quality… more
