- 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)
- … 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)
- …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
- 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)
- …incumbent will be responsible for serving as the point of contact for all alliance management issues related to ongoing GRACS activities. - The Director may also ... overall "big picture" view of projects and strategies. Demonstrated analytical and data management skills.- Experience pulling together abstract milestones and … 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)
- …to the Associate Director, Clinical Trial Central Labs to support high quality sourcing initiatives and procurement category management . Primary Activities ... and contractual decisions/actions as part of a cross-functional team. Appropriately escalate issues and concerns to procurement management and other functional… more
- Merck & Co. (Rahway, NJ)
- … Process, Preparation of Financial Reports, Procurement, Project Human Resource Management , Project Management , Quality Standards, Report Writing ... will be expected to lead small teams of auditors audits with limited management supervision in addition to actively performing audit work.Under the direction of the… more
- Merck & Co. (Rahway, NJ)
- …Development, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Research Management , Clinical Studies, Clinical Testing, Clinical Trials, Data ... Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new… 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)
- …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)
- …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)
- …of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data , developing and ... of multiple myeloma.Legend Biotech is seeking Supervisor, QC Micro as part of the Quality team based in Raritan, NJ. Role OverviewThe Supervisor, QC Micro is an… more
- Merck & Co. (Rahway, NJ)
- …pharmaceutical ingredients (API) process characterization work by learning and utilizing Quality Risk Management methodologies and tools for statistical design ... Quality Risk Assessment, Reaction Engineering, Risk Assessments, Statistical Data Analysis, Technical Writing {+ 2 more}Preferred Skills: Current Employees apply… more
- Merck & Co. (Rahway, NJ)
- …excellence in support of the portfolio of work, including interrogation of the data / science through technical reviews and exploring alternative ways to view and ... introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk mitigation, and risk… 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)
- …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)
- …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
- 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
