- Merck & Co. (Rahway, NJ)
- … issues (incl. any potential trends) to local country operations management and RCQM.Escalates significant quality /compliance issues and supports ... is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to conduct comprehensive analysis on all GMS material management aspects addressing data creation, data quality , governance needs and dealing with all ... team and collaborate in the design-implementation of Legend's Master Data Management program. We are looking for...MDG Materials, BOM, Recipes, MRP, MPS, Work Centers, Batch Management , Quality Inspection, Costing among others. Collaborate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support DS Program developments. This position provides expertise within the Biostatistics and Data Management teams by having the Medical / Scientific knowledge ... role. In addition, significant experiences in the use of data management systems (EDC, MDR, CDR), knowledge...of data driven methodologies for collection of quality data complying to industry standards CDISC… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … management of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management , lineage capabilities and the data ... cataloging data standards, data quality , and data management .- Develop...provisioning controls- Identify, assess, monitor, document, and communicate potential quality issues in the way data… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management ... principles in the design (and resolution) of key quality management system elements to ensure complianceTracks... quality systems by identifying and proactively resolving quality issues Develops, analyzes and compiles … more
- Merck & Co. (Rahway, NJ)
- …with cross-functional teams located in various geographical locations.Effectively communicate complex issues and challenges to senior management in a summarized ... Global Template asset, delivering enterprise-level capabilities through harmonized business processes and data .- The team is responsible for the operation of all our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QC Specialist, Equipment Management as part of the Quality team based in Raritan, NJ. Role ... QC Specialist, Equipment Management is responsible for equipment lifecycle management and Quality Control (QC) systems administration. Key Responsibilities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …respective CSPV groups, CROs, Affiliates in order to ensure high data quality and proactive detection and resolution of issues .Provide leaderships with risks ... for risk areas/process improvement to stakeholders via the QMS scheme (ie, Quality Management Review, Quality Review Board) across the global CSPV… more
- Catalent (Manassas, VA)
- …adherence to company quality standards procedures and policies. Inform the QA management if any out of specification or any deviations are found. Comply with ... POSITION SUMMARYThe Quality Assurance Specialist I is responsible for inspection...QA Supervisor in complete appropriate details; Report any housekeeping issues that need attention. Document all areas of non-compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and concise manner; must have an ability to see beyond the confines of MR data to broader business issues Demonstrated ability to work on multiple projects with ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Aequor (San Diego, CA)
- …patches and escalating issues to IT Business Partners Conduct source systems data quality analysis as needed Define standard operating procedures and perform ... techniques and evaluation criteria for obtaining results. Works on issues where analysis of situations or data ...job experience may be considered. Required Skills : PROJECT MANAGEMENT DOCUMENTATION DOCUMENTING USABILITY DATA QUALITY… more
- Aequor (Thousand Oaks, CA)
- …lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Quality Management Systems. offers the opportunity to be at the ... expertise in science and risk-based evaluation of complex process and product quality data , including ability to develop patient-oriented strategies that account… more
- Eisai, Inc (Nutley, NJ)
- …Operations Team s. Build s Dev O ps /Automation methods . On-Premises/Storage and Data management design and next generation DC services strategy . Review s ... , the a ssociate provides extensive , broad-based technical architecture , leadership, management experience and expertise to oversee our Amazon Web Services ( AWS )… more
- Eisai, Inc (Nutley, NJ)
- …technical support services for commercial analytics platform.Responsible for data ingestion, data transformations, data quality , data governance, ... digital data is ingested, processed, and delivered with high quality to dashboards, right next engagement platforms, and self-service analytics consumers. This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... and analytics, while partnering with other Enterprise Insights team Enterprise Data & Advanced Analytics function and translating into business impact. Relationships… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and ... updated Core Data Sheets, EU and US Documentation: As the project...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as… more
- Merck & Co. (Rahway, NJ)
- …to the SCIS user community.Runs and reviews publication management reports, identifies data quality issues , and either makes data corrections ... approve related deliverables. In addition, the Systems Coordinator will assist with maintaining data quality within our publication management system. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... integrating insights and analytics, while partnering with other Enterprise Insights, Data & Analytics functions and translating into business impact. Relationships… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …role in ensuring governance and continuous improvement as an enabler supporting product quality , patient safety, and data integrity, and contributes to the ... of industry regulatory changes as it applies to CSV Perform assigned Quality Systems activities including Document Management system, Change Control, Deviations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coding library management .Manages, reviews and approves medical coding of clinical data ensuring high quality ; creates and manages the synonym-lists to ... drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders… more
