- Eclaro (Madison, NJ)
- …Required Qualifications: Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation. Ability to work ... 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches… 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 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)
- …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
- 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
- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Monitor test execution, adjust schedule as needed to address tests failures. Documentation : Maintain detailed documentation of tests schedules, procedures, and ... workload to be evenly distributed amongst all analysts.Audit support: Ensure Good Documentation Practices and lab readiness are upheld for potential support of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Windows, etc).Executes, owns, assesses and participates in the development, revision and review of change controls, SOPs, and other documentation .Participates in ... to identify/remediate gaps in variety of processes.Experience authoring and executing documentation including but not limited to: SOPs, Work Instructions and… 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 ... required and 600, 601, and 610 is preferred.Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions,… 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
