- Legend Biotech USA, Inc. (Raritan, NJ)
- …and complex projects, provide status reports, and coordinate with cross-functional departments. Support Document Management system users with workflow handling ... for procedures, as needed.Issue batch related documentation and labels in support of GMP manufacturing.Reconcile GMP documentation following document lifecycle… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …distribution license applications and renewals and acting as lead paralegal support and coordinator of legal matters, under attorney supervision, on ... matters, and various other related projects (litigation readiness, e-discovery, document collections, etc.)). This position is also responsible for providing… more
- Merck & Co. (Durham, NC)
- …System.Provide guidance to staff for the implementation, management, and enhancement of document control systems on the global and local level and ensure consistent ... document management processes across all control documents.Coordinate responsibilities between...the Site Quality Council Meeting per the QC standard.Direct support of regulatory inspections and audits; presents Change Management,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against ... Study Oversight Plan (CSOP).Responsibilities Prior TMF experience required!- Reconcile the TMF document trackers generated by the CRO with the document archive.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Landscape Develop and maintain overview of Development SOP and associated document landscape including planned new documents, changes, and retirements. Create ... to ensure SOP updates are coordinated across functions and/or initiatives to support timely implementation while minimizing change. Identify, escalate, and plan and… more
- Genmab (Plainsboro, NJ)
- …and Development.Conduct current-state analysis, gap analysis, capability analysis, and document reference architecture for various R&D systems and functions.Provide ... data architecture skills to support core solution architecting and integration of data sources,...with other architects and IT&D functions to design and document innovative and optimal solutions for the R&D space.Evaluate… more
- Aequor (Swiftwater, MN)
- …of word processing software, strong writing and analytical skills to document software capabilities and functionality. Document programming standards and ... regarding quality standards. Be able to establish working relationships with other support and production areas in order to gather all the necessary information… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to another. This position involves collaborating with various teams to gather, document and implement solutions across various HRIS technologies, ensuring a focus on ... HRIS system (ie, SAP SuccessFactors).Lead respective workstream(s) to gather, document , implement and validate all system requirements for associated module(s).Serve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other ... of data outputs for collection of specific data, and support the authoring of documents for filings or responding...with a Bachelor's degree in a relevant science fieldSubmission document writing experience required Travel Ability to travel up… more
- Shimadzu Scientific Instruments (Houston, TX)
- …one's career and personal development ADDITIONAL COMPENSATION: For Service, Technical Support , Marketing & Sales Roles: Additional compensation is available through ... our team and play a key role in providing exceptional service and support for our physical measurement instrumentation. In this position, you will be responsible… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Reliability Engineer will be responsible for ensuring equipment/systems required to support an expanding Cell Therapy facility is appropriately purchased, qualified, ... an integral part of the CAR-T Equipment team in support of on-going clinical and commercial manufacturing as well...this. You have strong knowledge of cGMP requirements. You document proposals to reach a solution with relevant stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... problems related to publication projects, processes, or tasks, with management support as needed Exercises judgment within defined procedures and policies Acts… more
- Lundbeck (Bothell, WA)
- …opportunity to gain hands-on experience in analytical development to support drug development from early to late-stage clinical programs.ESSENTIAL FUNCTIONS: ... routine sample analysis Conduct routine LC-MS sample analysis to support characterization, stability, formulation development, and comparability studies by following… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... Works (SOWs). The AD will be responsible for providing supplier management support and oversight to the North America CMR Organization. Additional responsibilities… more
- Legend Biotech USA, Inc. (Charlotte, NC)
- …and Physician's Assistants to drive positive patient experiences. Legend CTCE's support a patient experience that focuses on the whole patient, addressing ... trends, and compliantly collaborate with internal/external partners to build/execute plans that support the education needs.The CTCE will also play a key role in… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Paralegal, Patent Prosecution Support (Hybrid) The Office of General Counsel is seeking a Patent Prosecution Paralegal to ... provide global patent prosecution support to the Intellectual Property (IP) organization. This position...are properly named and saved in the IP Group's document management system Review contents of patent application files… more
- Merck & Co. (North Wales, PA)
- …to support vaccination funding and reimbursement.Implements research programs to document the burden and cost of diseases, unmet medical need, barriers to ... including methodology to assess the value of vaccines, research to support vaccination policy initiatives, research on vaccine acceptance, and related cross-cutting… more
- Merck & Co. (Rahway, NJ)
- …and Clinical Finished Goods). Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain ... documentation to support critical CMC activities . Responsible for authoring the Clinical Supplies section of the study protocol as well as preparation and… more
- Merck & Co. (Rahway, NJ)
- …able to influence to gain alignment with stakeholders through use of data and logic. Support creation and management of all aspects of a given project, accountable to ... deliverables in Jira project with clear dependencies for accurate reporting, support business case creation, and implementation.Identify and manage dependencies of… more
- Merck & Co. (North Wales, PA)
- …of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of ... clinical trials and their results, document disclosure, and data sharing with external researchers.The Senior Director of Global Health Literacy & Health Equity is… more
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