- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the drug development process.- Collaborates within the function and cross-functionally to resolve issues pertaining to data management in clinical trials and ... to ensure data quality /integrity and regulatory compliance- Ensures that Data Management Plans are consistent and regulatory compliant across studies and… more
- Merck & Co. (Rahway, NJ)
- …submission standards (eCTD etc)Experience with data governance frameworks and data quality management tools.Familiarity with Agile methodologies and ... to gather requirements, test new features, and trouble shoot data related issues . Support user onboarding and...Data Lineage, Data Management , Data Modeling, Data Quality Control,… more
- Eisai, Inc (Nutley, NJ)
- …and inspection management , issue management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) ... inspection management , issue management , and oversight of the quality management system).Conduct complex audits of sites, vendors and internal… more
- Merck & Co. (Rahway, NJ)
- … quality activities within the assigned therapeutic area.- This includes operational quality management and inspection management activities.The CQOM will ... sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.The incumbent will be...knowledge of Good Clinical Practice with respect to digital data management (ie use of novel technology… more
- Aequor (Golden Valley, MN)
- …sample preparation techniques and delivery details into the Laboratory Information Management System (LIMS) software. Meet department Quality expectations ... by due date by completing the analysis of chromatography, data interpretation, titration methods, ELISA kits, manual calculation or...ISO 17025 quality requirements Identifying and addressing quality control issues Completing quality … more
- Merck & Co. (Lower Gwynedd, PA)
- …vaccines and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data . -A combination of molecular (eg, ... sample management -Partner with IT on interfacing sample management automation data and systems into LIMS...other stakeholders to ensure effective communication of plans and issues -Strong attention to detail with the ability to multi-task… more
- Repligen (Waltham, MA)
- … quality assurance. Proven experience with ISO 9001 audits and supplier quality management . Strong problem-solving skills, including root cause analysis and ... Monitoring and ReportingCollect, analyze, and report on monthly supplier performance data , including quality , delivery, and service metrics.Prepare and… more
- Petco (Irondequoit, NY)
- …metrics such as revenue, customer satisfaction, and partner productivity, analyze data to identify areas for improvement, and develop action plansCollaborate with ... store management to achieve sales targets and salon objectives, implementing...report any concerns to pet owners and store managementPerform quality checks to maintain a clean and safe grooming… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to ... standardize, optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …resources.Plan, allocate, and utilize resources and prioritize assignments. Contribute to management and escalation of issues for resolution.Coordinate vendor ... quality and adherence PV Regulatory Intelligence:Contribute to the management of PV Regulatory Intelligence and dissemination across CSPV stakeholders for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implementing study/program-specific quality plans for proactive quality management .Collaborate with the audit function, Data Management teams, MA ... Medical Affairs to facilitate the implementation of a risk-based quality management process fully embedded through trial...stakeholders and CROs to ensure high data quality , proactively identifying and resolving issues throughout… more
- Merck & Co. (Rahway, NJ)
- …workplace.Commitment to driving process robustness, reproducibility, and scalability through data -driven risk management and continuous improvement initiatives. ... Sciences, Biotechnology Manufacturing, Chemical Engineering, Coach Development, Collaborative Communications, Data Analytics, Deviation Management , Driving Continuous Improvement,… more
- Aequor (Minneapolis, MN)
- …updates.Responsibilities: VMS Management & Support: Maintain the VMS, ensuring data integrity and accuracy. Troubleshoot system issues , identify root causes, ... Job Title: Vendor Management System (VMS) Analyst - Temporary Contingent Worker...process improvements to enhance efficiency, reduce costs, and improve data quality . Invoice Support: Provide invoice validation… more
- Merck & Co. (Durham, NC)
- …and key performance indicators. Benchmark performance indicators against industry data . Look for continuous improvements opportunities RESOURCE MANAGEMENT : ... site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of ... maintaining compliance and quality .Must be able to discern the criticality of issues and communicate to management regarding complex issues .Ability to… more
- Merck & Co. (Lower Gwynedd, PA)
- …vaccines and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data . -A combination of molecular (eg, ... Department is seeking a Senior Specialist SOPs & Training Management to join our Integrated Logistics & Sample ...utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility… more
- Insmed Incorporated (San Diego, CA)
- …development and implementation of EDC systems to support clinical trials, ensuring data quality , compliance, and efficiency throughout the study lifecycle. The ... EDC systems to ensure data integrity and accuracyImplement and monitor data quality checks to identify and resolve discrepanciesCollaborate with partners… more
- Aequor (Thousand Oaks, CA)
- …to report onsite if systems go down and manual processes required. Experience with Quality Management Tracking Systems (QMTS) is preferred but not required - ... MS suite skills, with an emphasis on Outlook and Teams Experience with Quality Management Tracking Systems (QMTS) Smartsheet and SharePoint knowledge General… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical project management competencies within Clinical OperationsWork in collaboration with Quality Management and Quality Assurance to develop and ... Clinical Operations staff and to project teams for Vendor evaluation, selection , management and quality based oversightProvide guidance and training to Clinical… more
- Merck & Co. (Rahway, NJ)
- … Process, Preparation of Financial Reports, Procurement, Project Human Resource Management , Project Management , Quality Standards, Report Writing ... will be expected to lead small teams of auditors audits with limited management supervision in addition to actively performing audit work.Under the direction of the… more
