- Daiichi Sankyo, Inc. (Bernards, NJ)
- …epidemiological data , and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter expert ... all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily...evaluation, and if applicable, proposed actions (eg, changes to product information and/or other risk minimization measures)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director, Clinical Safety MD, will lead the development and implementation of integrated project/ product risk management strategies aimed at achieving the ... but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of events that occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate for this role demonstrates ... Actions (CAPA's) are developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible in handling day-to-day activities inclusive of execution, protocol management , vendor management , issues, deviations, corrections and remediation ... program to enable robust production, testing and release of product to patients.Key Responsibilities Executes the commissioning, qualification, requalification,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cell therapy product in the Multiple Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes working on ... for evaluation of changes to the same and their impact on the Carvykti product . Stakeholder management is required to drive and implement documentation template… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …tracking of quality metrics while ensuring high quality and complaint product supply.Key Responsibilities Support compliance activities for site Quality Operations ... within facility.Perform internal housekeeping audits.Perform analysis on quality indicating data and identifying trends.Provide oversight for trending of quality… more
- Terumo Medical Corporation (Somerset, NJ)
- …(CEP, LRP, LRR, CER). + Contribute to Hazard/Harm list creation as a part of Risk Management per product . + Research, create, and edit assigned clinical ... a high degree of independence + Ability to evaluate data and maintain in-depth understanding of product ...data for clinical/therapeutic area. + Working knowledge of data management (eg, data review… more
- Terumo Medical Corporation (Somerset, NJ)
- …Perform clinical evaluations. + Assist QS and engineering department in creation of risk management documents and IFU review. + Participate "subject matter ... Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: Scientific Data & Communication **Job Summary** The Sr. Medical Science Liaison (MSL)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... tracked, archived, searchable and accessible. Enters and tracks project and submission data in Regulatory Information Management system (Vault RIM). With… more
- Merck & Co. (Rahway, NJ)
- …etc.Material characterization and failure mode analysis and integration with combination product risk management .Stress-strain testing of different materials ... development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …authority and trust Serve as the expert on social media channel performance, risk management , competitive analysis, and emerging best practices to inform ... corporate channels to create engaging content journeys that support commercial priorities, data announcements and product launches Acts as primary content… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… more
- Merck & Co. (Rahway, NJ)
- …Database Management , Data Integration, Detail-Oriented, IT Infrastructure Management , Marketing, Procurement, Product Lifecycle, Product ... seeking an experienced professional with a strong background in Product Management to shape the vision and...standards, partnering with compliance and quality teams as needed. Risk & Issue Management Capture and manage… more
- Merck & Co. (Rahway, NJ)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for… more
- Merck & Co. (Rahway, NJ)
- …framework with all levels of management .Must have strong understanding of product management systems and tools, strong business and financial skills, ability ... Process, Manufacturing Scale-Up, Process Improvements, Product Commercialization, Product Lifecycle, Product Management , Regulatory Requirements,… more
- Merck & Co. (Rahway, NJ)
- …drug product , finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... and external stakeholders. Required Skills: Biopharmaceutics, Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness, Data… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Rahway, NJ)
- …NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions ... and knowledge capture of processes, which could include providing feedback on product and process development.These roles require adherence to GMP procedures, strong… more
- Merck & Co. (Rahway, NJ)
- … Management , Customer Experience Management , Management Process, Management System Development, Product Management , Requirements Management , ... with privacy, consent, and targeting frameworksEnsures cross-functional consistency with tech, data , and risk /legal functions on experience and regulatory… more
- Merck & Co. (Rahway, NJ)
- …executing analytical methods to release clinical drug substance and drug product and support both non-sterile and sterile manufacturing.- This role contributes ... a state of inspection readiness. Performs proactive resourcing planning and risk assessment strategies. Advances a culture of scientific excellence, GMP compliance… more
