- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies to identify, track, store, and disseminate critical CMR training documentation Ensures training and compliance to FDA Regulations, ICH Guidelines, and ... Accountable for budget records and prepares documents required for the budget review processes Develops requests for proposals; evaluates and provides input into… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …promptly in the MKC Support both clients and the management team with documentation and any additional requests to ensure seamless event execution. Relationship This ... outcomes Ensures consistency in support provided by the team through continuous review and improvement of existing processes Interprets and communicates goals and… 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)
- …in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author ... approvalsEnsure documentation of compliance with authorship and publication guidelines as...input to ensure availability of necessary datao Coordinate author review /approval & internal review approvalo Abstract/manuscript submission… more
- Tris Pharma (Monmouth Junction, NJ)
- …Legal team.The Contracts Manager/Paralegal supports the Legal department in the review , drafting and compilation of varied and complex business contracts across ... licensing and compliance requirements, including preparing and filing necessary documentation Manages company's IP portfolio, including trademark and copyright… 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
- 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
- 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)
- …to successfully transfer process to cGMP facility to manufacture products.Create, review and approve relevant QC documents, SOP's and WI's.Ensure microbiological ... key critical inputs to site environmental monitoring program.Perform peer review /approval of laboratory data.Utilize electronic systems (LIMS) for execution and… 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)
- …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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Under the direction of the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and modify Structured Product ... listing, track and archive affiliate labeling for global products and review proposed labeling from affiliates. Responsibilities Provide Regulatory support in the… 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
- 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
- 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
- Merck & Co. (New York, NY)
- …product workshops and conferences, as well as consistent and ongoing review of our company's promotional materials.Regularly monitoring their business performance ... and comply with legal and ethical standards.Maintain accurate and timely documentation of customer interactions and adhere to reporting requirements.Stay informed… 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
