- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …logbooks, and records. Utilization of electronic systems (LIMS) for execution and documentation . Create, review , and approve relevant QC documents, SOP's and ... multiple myeloma.Legend Biotech is seeking a Sr. QC Data Reviewer as part of the Quality team based in...operations in a controlled GMP environment.Key Responsibilities Perform peer review /approval of laboratory data including but not limited to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …lead and biostat to ensure availability of necessary dataCoordinate author review /approval & internal review approvalSubmit abstract/manuscripts with vendor ... supportFacilitate response to journal reviewer comments/requestsTrack publication tracking and announcements, in coordination with MI/ELeads the planning and… 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)
- …procedures, training, and process controls to identify, track, and maintain documentation around privacy requirements and data breaches. Conducts and maintains data ... privacy implications of business initiatives, product development, and marketing campaigns. Review relevant data protection agreements in coordination with Legal and… 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 ... input into study protocol profiles, final protocols and amendmentsLead document review & coordination for the protocol and amendments. Additional medical writing… 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)
- …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
- 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)
- …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)
- …strategy, comparability plans and data governance initiativesProvide critical input and review for validation master plans, PPQ and comparability protocols and ... reportsServe as reviewer /author of a variety CMC sections or regulatory submissions,...response teamDevelop and align a variety of process validation documentation templates ranging from control strategies to PVP and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Conference on Harmonization (ICH), and other applicable regulations. This includes preparation, review , and approval of CMC documentation for BLA Supplements ... Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation is complete, well organized, scientifically sound, of a high quality,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders.Summary This position is responsible for contract creation and review including: (A) overseeing the day-to-day operation of contract management ... clients (varying levels) and external vendors. Works with company attorneys to review legal language for company agreements. As necessary, negotiates with opposing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …RD/PV QA relevant activities including Business Plan, QQR, team building and management review .Involve and attend the Global QA relevant meeting and create the draft ... training, CVs, JDs- Collect, store and maintain all auditable documentation as per DSI Internal control- Support the Head...to the system and information to do that work.- Review the QA onboarding business slides edits and updates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the appropriate SME and follow up on the requests/escalation as needed. Process Documentation and ImprovementSupport review of study documents that pertain to ... and inbound sample shipment manifests,and tracking ad hoc shipments in trackers) Review the CRO partner Sample Management Plan, to document cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Business Process Procedures, functional specifications, test scenarios, end-user documentation and user manuals. Provide documented technical specifications of ... 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)
- …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
