- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the organization and affiliates as appropriate for the area of GxP audits assigned. Support conduct of document audits including eTMF, Clinical Study Reports and ... around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/ Document Audits supports end-to-end audit activities per audit program of GxP… more
- Aequor (Athens, GA)
- … Management (controlled documents, regulatory submission documents): Create and configure document templates and support site users in workflow configuration. ... Provide routine user support . Electronic Document Management (controlled documents, regulatory submission documents): Be the first line of user support for… more
- Eisai, Inc (Nutley, NJ)
- …Management: Assist with creating, updating and maintaining project trackers in EPICProvides support for document preparation and follow-up (eg Informed Consent ... profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, start-up, conduct and close-out)… more
- Eisai, Inc (Exton, PA)
- …of new DS/ADI processes and technologies, working with R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at the ... operations of the Upstream and Downstream Operations groups to support the supply of DS/ADI for pre-clinical and phase...Downstream production staff in the operation of equipment to support preclinical and phase I to III clinical trials.… more
- Repligen (San Diego, CA)
- …worldwide. C Technologies, Inc. (CTI) is a Repligen company. The Laboratory Support Specialist is responsible for providing technical assistance and expertise to the ... in drug discovery and development, manufacturing, and quality assurance. The Laboratory Support Specialist will provide support both at CTI/Repligen and on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Support Specialist, Sun-Wed 2nd Shift as part of the Technical Operations ... team based in Raritan, NJ. Role OverviewThe Operations Support Specialist will be part of the Technical Operations team responsible for the production of a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. SummaryThis position is responsible for the administration and operational support of Daiichi Sankyo's Veeva CRM system within IT. They'll collaborate ... with various sales and marketing customers to identify new and support existing CRM functionality. Primary responsibility will be around supporting our Omnichannel… more
- Merck & Co. (North Wales, PA)
- …the following responsibilities:1.) development of the integrated evidence strategy to support HTA/ reimbursement/ NITAG evaluations; 2.) development of overall Real ... care systems that can enhance value and use of products.Implements programs to document the burden and cost of diseases, unmet medical need, patient reported… more
- Merck & Co. (Rahway, NJ)
- … Document Requests ("IDRs"), gathering information, preparing analyses to support findings, performing tax research, and reviewing IRS transcripts and filed ... gather necessary information.Key ResponsibilitiesPrepare detailed responses to IRS Information Document Requests (IDRs), ensuring all information is comprehensive and… more
- Repligen (Waltham, MA)
- …supplier changes. Nonconforming Material Request (NCMR) Process and AnalysisInitiate and Document NCMRs: Identify and document nonconforming material detected ... Generate trend reports and dashboards to communicate findings and support supplier development strategies.Continuous Improvement and Risk Mitigation: Drive… more
- Aequor (Pearl River, LA)
- …Leverage public omics databases (eg, GEO, ENCODE, UK Biobank, CELLxGENE) to support hypothesis generation and validation. Provides scientific insights to innate and ... from raw data acquisition to data visualization and data analysis. Develop, document , and maintain reproducible computational pipelines and scripts using R and… more
- Merck & Co. (South San Francisco, CA)
- …of Research Laboratories is seeking a Senior Scientist specializing in AI/ML to support efforts in transforming the way PDMB leads the assessment of drug candidates. ... development. PDMB aims to leverage Generative AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory… more
- Formation Bio (New York, NY)
- …within transformation layers-using LLMs for named entity recognition, document summarization, classification, and schema alignment. Write robust, testable, ... frameworks to ensure quality, trust, and reproducibility of datasets. Document transformation logic, assumptions, and data lineage in collaboration with… more
- Twist BioScience (South San Francisco, CA)
- …with diverse internal teams, including engineering, marketing, sales, operations, and customer support , to break down silos, synthesize insights from each group, and ... and in alignment with business needs and strategic objectives.Gather and document detailed business requirements for projects, ensuring clarity and alignment across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process optimization initiatives and implementation of changes and projects. The support of daily operations (incidents, service requests, changes) for the ... for business casesCollaborate with business stakeholders to gather and document requirements, translate business requirements into technical specifications for the… more
- Shimadzu Scientific Instruments (Los Angeles, CA)
- …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
- Aequor (East Syracuse, NY)
- …testing, reference standard qualification, and comparability studies to support clinical and/or commercial GMP manufacturing.Duties / ResponsibilitiesDevelop, ... associated scientific technical documents.Perform testing of study samples to support upstream and downstream manufacturing process development, characterization, and… more
- Merck & Co. (Durham, NC)
- …a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham sites.- This includes Energy Center, Vaccine Bulk and ... Quality Labs, Material Management Storage Facility (MMSF) and projects. At times, support may extend to the Durham-Teknika site when requested. This position will… more
- Genmab (NJ)
- …labeling and labeling trends, proposing content as relevant to support optimized labeling.Ensure proper development, review, approval, implementation, maintenance, ... work instructions, templates, and associated documentsThis position may also support regulatory policy and/or intelligence deliverables:Monitor the regulatory environment,… more
- Merck & Co. (Durham, NC)
- …a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham sites.- This includes Energy Center, Vaccine Bulk and ... Material Management Storage Facility (MMSF) and projects when necessary. At times, support may extend to the Durham-Teknika site when requested. This position will… more
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