- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming ... reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.Oversees the execution of external… more
- 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
- Formation Bio (New York, NY)
- …the product development lifecycle. Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and ... and sites, providing support during health authority inspections, and offering guidance on quality issues . Ensuring vendors adhere to relevant quality … more
- Terumo Medical Corporation (Somerset, NJ)
- …The Sr. Clinical Quality Specialist collaborates cross-functionally to resolve complex quality issues , develop quality metrics and dashboards, and ... escalation for clinical suppliers Advising clinical teams on handling noncompliance and quality issues during study execution Collaborating with stakeholders to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …their expectations. Quality Assurance Provides secondary support to all USO Quality Management processes, including but not limited to Product Disposition ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR... management of contingent workers. Essential Functions Deviation Management Acts in role of Quality Assurance… more
- Merck & Co. (Rahway, NJ)
- …Compliance (IC), and Policy, Licensing and Evaluation (PEL).Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements ... GMP Auditing, GMP Compliance, GMP Operations, Good Manufacturing Practices (GMP), Inspection Readiness, Quality Auditing, Quality Management , Quality … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders to proactively identify and mitigate potential issues Compliance & Quality Assurance Partner with NNI Patient Safety Management to ensure timely ... and Compliance, Global Safety, and centralized teams (eg, Training and Documentation, Quality , Supplier and Contract Management and Digital Enablement). This… 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)
- …our patients, partners, and colleagues.As a Technical Product Manager for the Compliance, Risk, Quality , & Vendor Management product you will spend a lot of time ... across the organization. Candidate will be accountable for the entire Compliance, Risk, Quality , & Vendor Management product from the prioritization and roadmap… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contract quality and adherence PV Regulatory Intelligence: Oversees the Management of PV Regulatory Intelligence and dissemination across CSPV stakeholders for ... the key DSI contact for PV service providers to address, escalate issues requiring attention or resolution, and proactively drive operational excellence and… more
- Capital One (New York, NY)
- …audits of controls in cloud-based environments 4+ years of experience in risk and data management 4+ years of experience performing data analysis in ... microservices), information security (application security, network security, cyber security, data protection), information systems risk management , information… 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
- Terumo Medical Corporation (Somerset, NJ)
- …Corporate Counsel and Chief Privacy Officer is responsible for managing the privacy, data management , and security program at Terumo Americas Holding, Inc. and ... with effective Legal support and advice on company strategies regarding privacy, data management and security and their implementation while ensuring adherence… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....make a difference? The Position To ensure oversight and management of all contract and vendor related activities in… more
- Terumo Medical Corporation (Somerset, NJ)
- …including authorizations, roles, and data access control. + Ability to lead critical issues involving SAP on GCP, Fiori with S/4hana and SAP HANA. + Knowledge of ... Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for… more
- Terumo Medical Corporation (Somerset, NJ)
- …Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: Field Inventory Management **Job Summary** Field Inventory Specialist will assist in the ... management and control of inventory through various sales and...maximize ROI, as well as review operational processes and data to identify opportunities for improvement. **Job Details/Responsibilities** Manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Management :Develops talent through providing focused career development, performance management and manages retention.Fosters a high- quality culture ensuring ... immune disorders. Job Summary: Provides operational oversight to study management personnel within assigned program(s). Provides managerial oversight to colleagues… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operate PPM systems and processes.- Apply AI tools to automate and improve portfolio data quality .- Onboard new projects and teams to PPM systems.- Assist with ... training modules and support decision-making for global/regional projects Evolve Project Management (PM) Processes: - Contribute to improving project management … more
