- Legend Biotech USA, Inc. (Piscataway, NJ)
- …analysis of tumor samples and tissues from mice and NHPAnalyze, summary, review and present dataParticipate in assay development and qualificationMaintain good ... documentation in ELN, paper notebook and log books.Perform additional exploratory and investigational studies with various techniquesRequirements Ph.D. or Master… more
- Genmab (Plainsboro, NJ)
- …relevant mitigatory actions, to senior leadership and project teams Prepare/oversee/ review /maintain regulatory documentation (eg regulatory sections of clinical ... Participate in the development of and assess the appropriateness of submission documentation to support successful IND/CTAs as well as BLAs/MAAs. Evaluate various… 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Omnichannel Orchestration teams on coordination with agencies for Medical/Regulatory/Legal review planning schedules Best Practice Research and Documentation : ... customer groups. The owner is responsible for coordinating with agencies for regulatory review planning, and ensuring best practices in SEO and SEM. The owner… more
- Merck & Co. (Rahway, NJ)
- …chain deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders. Works directly in the SAP ... Drug Product and Clinical Finished Goods). Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply… 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
- Merck & Co. (Rahway, NJ)
- …and assemble quarterly consolidated Balance Sheet and Income Statement review packages for presentation to Senior Management, highlighting critical financial ... insights and trends.Undertake the preparation and review of supplementary analyses and disclosures related to the Balance Sheet, Income Statement, Cash Flow… 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)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- …submissions/variations, 510(K)s, CE markings. - Lead the development, communication, and review of Regulatory Strategies and execute on various deliverables for ... to device and combination productsSupport device design control activities and documentation reviewsProvide evaluations of regulatory state of affairs of any devices… more
- 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
- 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
- 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)
- …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
- 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)
- …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)
- …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
