- Merck & Co. (Rahway, NJ)
- …for and support batch processing readiness and execution activities.Prepare, review , and/or approve GMP Documentation as appropriate.Author/Approve Standard ... through participation in equipment design and testing as well as preparation, review , and completion of GMP documentation .Support compliance with Industrial… more
- Merck & Co. (Rahway, NJ)
- …for and support batch processing readiness and execution activities. Prepare, review , and/or approve GMP Documentation as appropriate. Author/Approve Standard ... in equipment design and testing as well as preparation, review , and completion of GMP documentation . Support...as preparation, review , and completion of GMP documentation . Support compliance with Industrial Hygiene (IH) program by… more
- Merck & Co. (Rahway, NJ)
- …and standards.-MAJOR ACTIVITIES AND RESPONSIBILITIES: Major activities and responsibilities include: Review animal health pre-clinical and clinical study reports and ... audit reports.- Reviews audit responses to ensure appropriate actions and documentation has occurred.- Distributes audits to management.Assist in performing facility… more
- Merck & Co. (Rahway, NJ)
- …Post Summary Correction (PSC) requests to brokers, including maintaining required documentation in our Company systems of recordPerform monthly Post Entry ... Review of entries and any follow up needed, including counseling of party responsible for error and management of PSCs with broker, if neededCollaborate with… more
- Merck & Co. (Rahway, NJ)
- …nomenclature data into a centralized databasePerforming data integrity review activities, including proofreadingDeveloping rules to ensure data qualityContributing ... FAIR principles and other standardsExperience writing and maintaining process documentation #eligibleforERPCurrent Employees apply HERE Current Contingent Workers apply HERE… 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)
- …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)
- …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)
- …team adherence to the CSOP and manage the overall implementation and documentation of the CSOP including activities conducted by CROs and vendors.Provide operational ... input into study protocol profiles, final protocols and amendmentsLead document review and coordination for the protocol and amendments. Additional medical writing… 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
- 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)
- …OLT with assessing portfolios, preparing documents and communications, and conducting a final review of materials prior to OLT submission. This position acts as a ... the OEDC Administrative Coordinator in the fulfillment of their duties. This includes review and editing of OEDC communication, including the website, FAQ site, and… 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 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
