- Eisai, Inc (Nutley, NJ)
- …eTMF assist with set-up requests and Assists with filing and archiving project documentation in the eTMF within the defined timelines Performs eTMF internal reviews, ... Performs detailed eTMF CRO quality check reviews with follow-up for missing documentation under the supervision of the COL Provides general enrollment figures to… more
- Eisai, Inc (Nutley, NJ)
- …interruption risks.Change Management: Create a regulatory / non-regulatory change review and change management process.Team Leadership: Lead the global teams ... solution/strategy clearly and concisely in both verbal and written format.Excellent documentation and reporting skills to meet legislative, regulatory, and corporate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Engagement. This position will be responsible for supporting the global Cross Border Engagement Review (CBER) process and will also serve as the initial reviewer ... approvers, and CBER Steering Committee members to coordinate the submission and review of Cross Border Engagements. Additionally, this role will consult with… 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
- Merck & Co. (Rahway, NJ)
- …the Company and compliance with all governing regulations. This may include review of documentation and deviation investigations, ensure permanent inspections ... support and monitoring, change control oversight and management, metric review , and review of annual product reviews. This also includes building effective… more
- Merck & Co. (Rahway, NJ)
- …Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in ... with internal and external reviewers, and guiding the posting through review and approval. Collaborating with clinical teams, including requesting necessary data… more
- Merck & Co. (Rahway, NJ)
- …and/or subsidiaries for all applications and submissions and responsible for regulatory review and final approval for all submissions and associated documentation ... approval according to the committee charters (including therapeutic area Document Review Committees, Product Development Team, Early Development Team, and label… more
- Merck & Co. (Rahway, NJ)
- …agencies and/or subsidiaries for all applications and submissions.Responsible for regulatory review and final approval of all submissions and associated ... documentation .Provides expertise as the Global Regulatory Lead to Product...coordinates cross-functional regulatory support for development programs and marketed products. Review and provide final approval of local registration study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the appropriate SME and follow up on the requests/escalation as needed. Process Documentation and Improvement:Support review of study documents that pertain to ... inbound sample shipment manifests, and tracking ad hoc shipments in trackers). Review the CRO partner Sample Management Plan, to document cross-functional agreements… 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)
- …functional teams for one or more clinical study programs which may include review of vendors agreements and policies, external training materials (eg, CRO training ... study agreements, research collaboration agreements, informed consent forms or other documentation for clinical trials. Works under supervision to: (1) to respond… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Works directly with key business stakeholders & external partners to review , analyze and prioritize business requirements and provides process functional and ... for reviewing unit test plans to ensure all requirements have been met. Review integration test plans and perform integration testing as necessary to ensure that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation or qualification of global GxP and Non-GxP computer systems.Create and review various validation documentation such as Validation Plans, Protocols ... compliance, and global Quality expectations. Partner with global Quality departments to review global policies, inspections and audit CAPAs, and vendor audit … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to shipAssists in ... master label text, translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as the overall process. Accountable for the maintenance, and peer review of key Daiichi Sankyo procedural documents (SOPs/SOIs), including external data ... operating models. Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi… 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)
- …that management can ensure that corrective action can be taken. Assist in the review all technical solution documentation created and maintained by the vendor ... for the EDW, integration, enterprise scheduling, and database environments. Continuously review performance of internal and external monitoring processes and tools… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and resolving matters of confidentiality. Coordinating a budget planning and review meeting with Finance Business Partner, Function Head and stakeholders. Partner ... Tech Unit Regional Function SharePoint site as well as business forms, documentation and other web forms.- Process Improvement- Drives process, efficiency, and… 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
