- Daiichi Sankyo, Inc. (Bernards, NJ)
- …candidate will provide knowledge-based coordination, authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted ... authoring, revising, and managing the day-to-day activities associated with the Dose Preparation Instructions Pharmacy Manual in support of the DSI portfolio.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and supervise multiple units within the CAR-T process operations (ie component preparation manufacturing, MFG support operations, Mock cell, and CAR-T process) ... responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job… more
- Beckman Coulter Diagnostics (Miami, FL)
- …(ISF) are maintained and kept current; assist in audit readiness and preparation . Support the in-house biorepository by receiving, shipping, and tracking clinical ... to build a meaningful career, be creative, and try new things with the support you need to be successful.Beckman Coulter Diagnostics is proud to work alongside a… 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
- Raytheon (Tewksbury, MA)
- …Raytheon. The department is responsible for the design, development, integration, and support to production builds, and lifecycle support of Raytheon ... products.This position is for a multi-disciplined Senior Hardware Production Support Engineer, capable of solving design and manufacturing problems and providing… more
- Raytheon (Tucson, AZ)
- …coordination, preparation of detailed technical team reports, and proposal support .What We OfferOur values drive our actions, behaviors, and performance with a ... circuit design, CCA assembly, electrical test and production/supplier/sub-tier supplier support of test equipment, test automation scripting, test conduction, sensor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, ... US FDA and EU EMA) for assigned projects with support , on CMC matters. This position supports Health Authority...EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from preparation of the briefing book, to training and preparing… more
- Eisai, Inc (Exton, PA)
- …suites in a cGMP biopharmaceutical pilot plant, including scheduling of staff, preparation and close-out of documentation, manufacture of DS/ADI materials, and suite ... operations of the Upstream and Downstream Operations groups to support the supply of DS/ADI for pre-clinical and phase...Be responsible for the scheduling of staff and facility, preparation and close-out of documentation, and maintenance of the… more
- Eisai, Inc (Boston, MA)
- …Operations and Biostatisticians in the ingestion, streaming and producing dashboards to support projects across various stages of development. This role will be ... Proactively propose alternative solutions to optimize business outcomes.AI-Driven Data Preparation : Skilled in utilizing AI and machine learning techniques for… more
- Merck & Co. (Millsboro, DE)
- …and operation. Performs manual and/or automated operations, general maintenance and support functions Housekeeping in all work areas - Executes facility ... to approved procedures Assist with performing aseptic procedures including media preparation , antigen inoculation and harvest, tissue culture preparation and… more
- Merck & Co. (Rahway, NJ)
- …Present findings and make recommendations as needed. eBilling Oversight and Support : Oversee the eBilling function, ensuring compliance with policies, financial ... practices, and SOX requirements. Provide support and training for legal staff and outside counsel on the eBilling system and developing resources for new users.… more
- Genmab (NJ)
- …following up on action items (meeting schedule and recording, meeting minutes preparation , meeting material filing in the eTMF, etc.)Coordinate logistics for key CTT ... Management:Organize and track clinical trial documentation and reportsAssist in preparation of reports, presentations, and study-related materialsDevelop and maintain… more
- Eisai, Inc (Bethesda, OH)
- …closely with Biostatisticians in the Stat Methodology / Machine Learning group to support projects across various stages of development. This role will be integral ... key trends and patterns, and provide data-driven recommendations that support and guide strategic decision-making.Data Storage & Processing: Extensive experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices ... develop regulatory strategy and provide input on IVDR requirements to enable and support timely registration of both therapeutic and diagnostic products in the EU as… more
- Formation Bio (New York, NY)
- …developing and implementing medical writing strategies and operational plans to support Formation Bio Clinical Development activities. The Medical Writer will have ... meetings). Leads the development of style standards and guidelines for preparation of documents, including those submitted to health agencies, and ensures… more
- Merck & Co. (Durham, NC)
- …and collaboration skills responsible for supporting Operational Readiness projects to support biological processes for a new manufacturing facility or currently ... up and operations, and specific assignments. This position is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Safety (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) ... Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The purpose of this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming ... projects, act as statistical programming subject matter expert (SME) to support outsourced programming activities and be responsible for the programming technical… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …IQ, OQ, PQ, requalifications, cleaning, sterilization and utilities. This position will support the day to day execution of validation activities, and related ... documentation/technical writing overseen by support of more senior Validation Engineers. This is an...OQ, PQ & PV), data analysis and final report preparation for utilities, equipment and instrumentation Maintain effective communication… more
- Merck & Co. (Rahway, NJ)
- …in our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- ... Positions will support development and clinical manufacturing and supply, as part...processing activities that include room setup, equipment and material preparation , equipment assembly and disassembly, cleaning, and processing of… more
