- 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
- 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)
- …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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations and root cause analyses on any supply disruptions or material quality related issues .Support Quality , Regulatory and Financial audits.Provide ... accuracy and compliance by maintaining Info records, source lists, material management , RFQ and contracts.Meet assigned data maintenance timelines and special… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …automation and controls system software, hardware and associated interfaces inclusive of data management , issues , deviations, corrections, remediation and ... will be responsible in handling day-to-day activities inclusive of life cycle management , issues , deviations, corrections, remediation and improvement efforts of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support specific and real-time floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample management and data ... according to standard operating procedures and batch records, while recording production data and information in a clear, concise format.Perform tasks on time in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations and root cause analyses on any supply disruptions or material quality related issues .Support Quality , Regulatory and Financial audits.Provide ... as supporting Procurement execution activities, cost analysis, inventory and vendor management - in accordance with company policies and site-specific procedures.The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …stakeholders including but not limited to Operations, MSAT, Facilities, C&Q, Project Management , and Quality .Work closely with Sr. Manager, Strategic Initiatives ... but not limited to IQ/OQ/PQ, EMPQ, APS, PPQ, preferred.Experience with change management /change control and quality systems.Experience with FMEA and risk… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …drives and manages an effective, holistic continuous improvement, problem solving and management program to improve process execution and system utilization of the ... and to avoid duplication of efforts across sites.Apply and teach change management methodology in all aspects of the plant operational excellence effortsIdentify,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with multiple internal and external stakeholders to optimize intake workflows, enhance data quality , and drive continuous improvement Develop, maintain, and ... Submissions and Compliance and the centralized teams (eg, Training and Documentation, Quality , Supplier and Contract Management and Digital Enablement). The… more
- Merck & Co. (Rahway, NJ)
- …in future SAP module implementations and other system changes 2. Reporting and Data Analytics Dashboard Management : update and maintain dashboards for monthly ... Excel capabilities, and digital collaboration tools (Teams, SharePoint, Power BI) Data Analysis and Performance Management : -Strong analytical skills with… more
- Merck & Co. (Rahway, NJ)
- …Content Management , Content Management Systems (CMS), Cross-Cultural Awareness, Data Management , Data Quality Assessments, Documentation Review, ... questions and issues related to submission content management , quality and standards complianceEngage across functional...process requirementsDevelop and evaluate metrics as part of a data quality monitoring plan to determine where… more
- Merck & Co. (Rahway, NJ)
- …value chains and related business processes. Proficiency in project and portfolio management tools and techniques. Strong data analysis skills with competence ... , Commercial Strategies, Communication, Cross-Cultural Awareness, Cross-Functional Communications, Customer-Focused, Data Analysis, Driving Continuous Improvement, Financial Risk Management… more
- Avet Pharmaceuticals Inc (East Brunswick, NJ)
- …and logistics to support manufacturing operations while partnering with Manufacturing, Quality , Sales, Marketing, and Finance. Leads the monthly S&OP processes ... * Oversee the timely validation, analysis and publishing of operational data and executive-level reports that monitor end-to-end supply chain performance against… 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)
- …capital projects. This role includes project procurement planning, supplier management , contract negotiations, and ensuring compliance with company policies and ... category strategy alignment, sourcing and contracting execution, contract and claims management , project and risk management practices, and supplier relationship… more
- Merck & Co. (Rahway, NJ)
- …teams. Problem Solving: -Remove roadblocks, resolve conflicts, and escalate issues when needed. Communication: -Foster collaboration, ensure transparency, and engage ... governance bodies. - Excellent interpersonal and communication skills Project Management : -Drive project schedules, set clear priorities, and monitor performance… more
- Merck & Co. (Rahway, NJ)
- …and late-stage transfers, SoftMax Pro template validation, analytical life cycle management , and release and stability testing. The successful candidate must be ... various stakeholders, including Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to… more
- Merck & Co. (Rahway, NJ)
- …validation, early and late-stage analytical transfers, analytical life cycle management , and release and stability testing. The successful candidate must ... closely with various stakeholders, including Analytical Development, External Capabilities, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to… more
