- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author ... approvalsEnsure documentation of compliance with authorship and publication guidelines as...input to ensure availability of necessary datao Coordinate author review /approval & internal review approvalo Abstract/manuscript submission… 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)
- …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)
- …leadership.Collaborate on the development of monitoring plan templates including review and annotation of monitoring-related documentation .Contribute to and ... study/CRO plans across the portfolio.Ensure study-specific monitoring plans meet the above standards. Review quality oversight plans that CRO CRAs have in place to… 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)
- …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
- Merck & Co. (New York, NY)
- …product workshops and conferences, as well as consistent and ongoing review of our company's promotional materials.Regularly monitoring their business performance ... and comply with legal and ethical standards.Maintain accurate and timely documentation of customer interactions and adhere to reporting requirements.Stay informed… 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)
- …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
- Merck & Co. (Rahway, NJ)
- …submissions/variations, 510(K)s, CE markings. - Lead the development, communication, and review of Regulatory Strategies and execute on various deliverables for ... to device and combination productsSupport device design control activities and documentation reviewsProvide evaluations of regulatory state of affairs of any devices… 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
- 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 (1) one Principal Administrative Associate II to function as a Quality Control Case Reviewer , who will: - Ensure the accuracy of the review sample by ... conducting preliminary WMS inquiries and case review ; utilize reports to verify that sample is auditable;...case records requested by external auditors and identify missing documentation and processing errors that could result in negative… 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
- 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
- Mizuho Corporate Bank (New York, NY)
- …and enhance Credit Review 's Risk Assessment process. + Draft potential review issues for discussion with relevant Reviewer -in-Charge, Credit Review ... About the Team Credit Review provides the Board and bank management with...to opine on the adequacy of facility underwriting and documentation , including, but not limited to, collateral, repayment sources,… more
