- 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
- 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
- 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
- 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
- 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
- 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)
- …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
- 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …system change control, validation, and upgrade activities Governance & Change Management Support Safety/ Quality /Training leadership in operational and governance ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and works cross-functionally with internal departments on Regulatory Affairs related issues . Essential Functions With direction from management participates on ... emerging issues and proactively developing solutions. With direction from management participates in FDA and HC submission planning meetings to ensure clear… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve as Technical Complaint Processing Team's safety system manager Oversight of quality management : Facilitates and/or participates in regularly scheduled call ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with a focus on corporate functions (eg, Procurement; Real Estate; Digital, Data and IT; Finance and Tax) and complex and high-risk supplier contracting. ... Provide Strategic Legal Counsel Interpret complex internal and external business issues related to contracting and recommend best practices and solutions Proactively… 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
- ValSource, Inc. (Rahway, NJ)
- …Part 11 compliance and latest industry expectations for data integrity. Project Management experience in managing scope, cost, schedule, quality , and risk is ... Requirements Minimum of 7 years’ experience with increasing responsibility in validation/ quality service and project management of life sciences, biotech… 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)
- …the team alignment with functional objectives.Ability to communicate program progress, issues , and mitigation plans to the senior management .Innovative mind-set ... and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The… more
