- 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
- 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)
- …etc.)-Ensure operational study-level timeline, budget, deliverables and quality management -Facilitate escalation and resolution of issues with CRO/ vendors/ ... the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery-Lead...with the CRO, feasibility team and the study team.-Assist Data Management with development of the clinical… 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …maintaining compliance and quality .Must be able to discern the criticality of issues and to communicate to management regarding complex issues .Ability to ... inspection readiness within facility.Perform internal housekeeping audits.Perform analysis on quality indicating data and identifying trends.Provide oversight… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …this leader.Key Responsibilities Lead and oversee all engineering management including asset/reliability, data systems/automation and ... a change agent to promote flexibility, creativity, and accountability.Advanced project management skills, responsiveness to issues , and demonstrated passion for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be responsible in handling day-to-day activities inclusive of execution, protocol management , vendor management , issues , deviations, corrections and ... outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required… 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)
- …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)
- …change controls, document control, process improvement, process validation and data management .Partners with Operational Excellence to implement ... experience ownings SOPs, change controls, investigations, CAPAs and other quality system actions.Ability to engage all levels of the organization,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …equipment and capital expenditures (CapEx), ensuring alignment with business objectives, quality , compliance, and cost optimization. The role will work closely with ... cross-functional stakeholders including Manufacturing, Facilities, Maintenance, Engineering, Quality , Finance, Supply Chain and Global Procurement to meet site and… 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)
- …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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …Instrument data , Spotfire, Thoughtspot, data lakes, dashboards, data models, etc.).Proficiency in portfolio management software such as Planisware, ... execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational… more
- Merck & Co. (Rahway, NJ)
- …creative, and resourceful in finding solutions to user problems.Maintain detailed and accurate data management practices, adhering to quality and compliance ... a pivotal role in supporting our IT processes and ensuring seamless service management and delivery. We are looking for a dedicated professional who can effectively… more
- Merck & Co. (Rahway, NJ)
- …quantitative systems pharmacology, model-based drug development (MBDD), or scientific data management .- Proven experience leading cross-functional teams to ... Sciences, Process Leadership, Product Management , Rapid Prototyping, Risk Management Framework, Scientific Data Management , Scientific Software… more
- Merck & Co. (Rahway, NJ)
- …collaborate closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success ... to ensure compliance with industry regulations.- Able to report any recurring issues or trends to management for further investigation.Cleanroom Environment:… more
