- Novo Nordisk Inc. (Plainsboro, NJ)
- …non-functional business requirements Excellent technical writing, document organization, technical document review and analytical thinking skills are ... Position The Senior Solutions Architect (Commercial Data Mgt & Analytics) is a technical leader with a deep understanding of business goals, business processes and… more
- Aequor (Seattle, WA)
- …Client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting. ... Job Description: Top Skills: - 2&plus years of Document Control & Reporting Experience, - Veeva experience preferred - Technical troubleshooting - Self… more
- Catalent (Manassas, VA)
- …complex formulations to help create engaging new products consumers will love.The Document Control Specialist - 2nd Shift is responsible for creating and maintaining ... and maintenance of all documentation related to the Quality System utilizing technical writing skills to ensure proper formatting, numbering, and organization of all… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …provide oversight of technical operations activities including data or document review , risk assessments, CAPAs, and continuous improvement activities. They ... address and resolve manufacturing issues.Key Responsibilities Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an opening in our Monmouth Junction, NJ facility for an experienced Technical Services (TS) Engineer I. The TS Engineer I provides direct validation support ... and Drug Administration (FDA) requirements. Responsible for assigned aspects of Technical Services activities while complying with cGMPs, SOPs and FDA requirements… more
- Aequor (Seattle, WA)
- …- 2&plus years of experience with SuccessFactors - Excellent communication and technical trouble shooting skills - ServiceNow experience preferred - Excellent time ... Must have basic GMP and Quality knowledge. Intermediate skills to navigate a document management system (DMS) and Learning Management System (LMS). Must be able to… more
- Aequor (New Brunswick, NJ)
- …program in support of the change Perform change control impact assessments and document the stability assessment in change controls. Review and endorse change ... expanded reviewer. Initiate change controls related to stability operations Provide the technical requirements in a Master Stability Protocol, review and approve… more
- Catalent (CA)
- …and influencers.Prepare well for calls/visits, anticipating and addressing barriers. Document and validate customer needs before presenting solutions.In cooperation ... not limited to, pricing, contract extensions/amendments, forecasting, periodic business review meetings, and support of other customer service-related issues.Other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for assigned clinical studies - CTD submissions/Others - May support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist ... - Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance, and patient safety related to managing assigned clinical trials, document management and management of clinical trial management systems and archiving ... to: Management of clinical trial documents, including but not limited to document receipt, distribution, uploading, indexing, archiving and initial quality review… more
- Merck & Co. (North Wales, PA)
- …regulatory success together with risk mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of ... business processes and systems.Collaborate with partner groups in critical review of submissions to ensure compliance, scientific excellence, accuracy and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …supervision/support to resolve some sophisticated issues. He/ She will serve as technical specialist within job function. Thinks logically and acts decisively. Key ... (LIMS). Prepare documents and coordinate Sample shipment (internal and external shipments). Review logbooks and/ or LIMs to align physical quantities of samples in… more
- Shimadzu Scientific Instruments (Tampa, FL)
- …and Culture Employee Resource Groups (ERGs). ADDITIONAL COMPENSATION: For Service, Technical Support, Marketing & Sales Roles: Additional compensation is available ... the regional office is open and functional during business hours. This document attempts to communicate the traditional, physical and environment demands associated… more
- Merck & Co. (Rahway, NJ)
- …and technical writing skillsProficient in MS Office Platform and document storage systemsAn ability to foster innovation, creativity, and self-initiative along ... individual to work in a fast-paced job that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position… more
- BioAgilytix (Durham, NC)
- …professional and technical knowledge by attending educational workshops; review professional publications; establish personal networksAssist in document ... through thorough monitoring and audits. Partnering with the Operations team, you will review key procedures in a GxP environment, highlight any gaps or deviations in… more
- Merck & Co. (Rahway, NJ)
- …and technical writing skillsProficient in MS Office Platform and document storage systemsAn ability to foster innovation, creativity, and self-initiative along ... individual to work in a fast-paced job that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that management can ensure that corrective action can be taken. Assist in the review all technical solution documentation created and maintained by the vendor ... systems and applications. The individual in this role owns the support of technical design / development, testing / debugging, deployment, and manages the ongoing… more
- Merck & Co. (Boston, MA)
- …responsibility will include the clinical pharmacology support of the Common Technical Document (CTD) and label, including relevant compound/program life-cycle ... TMed at governance for the Immunology portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of external-based… more
- Merck & Co. (Rahway, NJ)
- …and technical writing skillsProficient in MS Office Platform and document storage systemsAn ability to foster innovation, creativity, and self-initiative along ... individual to work in a fast-paced job that provides both technical and project management responsibility. The Associate Specialist - Manufacturing Automation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for effective and efficient global processes for labeling development and review , and resourcing that incorporates input from cross-functional subject matter experts ... oversee, and manage implementation of global labeling development and quality review processes, templates, metrics, and systems, while ensuring compliance with FDA,… more
