- Legend Biotech USA, Inc. (Raritan, NJ)
- …as well as other microbiological assays.Utilize electronic systems (LIMS) for execution, documentation , review of testing.Perform tasks in a manner consistent ... in the treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role OverviewThe… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …periodic review process for procedures, as needed.Issue batch related documentation and labels in support of GMP manufacturing.Reconcile GMP documentation ... Document Control Specialists to meet goals and deadlines.Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with… 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)
- …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)
- …for Changes and process improvements. Provide oversight, Manage Implementation and documentation of PV Safety systems Change Request supporting documents and ... evidence. Review of Change Request, impact analysis, supporting documents and...tracking and investigation of quality and compliance issues- Other Review and update of DMA Procedures. Maintain compliance with… 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)
- …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)
- …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)
- …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)
- …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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …GMP decisions.Lead the establishment and improvement of QA practices to ensure accurate documentation of all review and release activities for drug products, ... Responsibilities Manage the team responsible for drug product batch record review and drug product release practices.Develop positive relationships with the QA… more
- 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
- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …/approval of laboratory data.Utilize electronic systems (LIMS) for execution and documentation of testing.Create, review and approve relevant QC documents, ... SOP's and WI's.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Other duties will be assigned, as necessary.Job duties performed routinely require exposure to and handling of biological materials and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …efficiently.Oversee change management procedures, including business engagement, impact analysis, documentation review and approval, user testing reviews, ... ensuring smooth and controlled changes to minimize risks and disruptions associated with GMS activities.Identify opportunities for process improvement and optimization within the MDG areas, leveraging SAP functionalities and best practices to drive efficiency… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …integrityExecutes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentationParticipates in authoring ... and 600, 601, and 610 is preferred. Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV… more
