- Legend Biotech USA, Inc. (Raritan, NJ)
- …projects.Support the enhancement and Global harmonization of the supplier qualification program , including management of the electronic systems for this ... Management Review (QMR).Support management of the Quality Management Review (QMR) program .Support continuous improvement efforts through the monitoring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to drug product manufacturing required to deliver time, cost, quality, and risk management to teams.Experience with Healthy Authority requirements and regulatory ... management and delivery of the integrated project and program plans, ensuring alignment in support of the overall...guidance to leadership including trade-off and implications assessment (value, risk , cost, time) to the project or program… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to support global process validation activities in support of the commercial Carvykti program both within Legend but also externally with our program partner ... partners to track changes to our material/ raw material program and develop best practices for evaluation of changes...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)
- …and budget related activities.Process-oriented with strong analytical skills for risk identification and management .Ability to translating complex analytics ... contributor in the reporting, forecasting, and budgeting cycles for the CARVYKTI manufacturing program (US & EU). This role will be responsible for partnering with… 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 ... across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.Key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards ... in fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to realize your potential? The Position The Director of Alternative Models Program Management is responsible for ensuring the timely execution of ... By driving the collaboration among teams and key stakeholders, the Director of Program Management oversees the coordination and execution necessary to design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams.Ensure consistent and proactive representation of Quality at all stages of the program management process.May Interact with management at all levels ... access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems and processes of the Daiichi Sankyo's GxP group.Together with regional management teams plans, will support, conducts and reports internal systems and ... for the area of GxP audits assigned.Responsibilities:Execute the audit program for internal systems as applicable for the area...in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary point of escalation for ... end-to-end processes and resourcing for case processing. This role leads the Case Management Activities and oversight of case Intake, Triage and case processing. The… more
- Merck & Co. (Rahway, NJ)
- …Drug Development, Logistics, Multiple Therapeutic Areas, Process Optimization, Publications Management , Regulatory Compliance, Risk Management , Sourcing ... and the operational/executional arms within the business.- - The Program Clinical Supplies Project Manager ( Program CSPM)...(ie Bulk Drug Product). Oversees all bulk drug supply management and ensures proper allocation of drug product as… more
- City National Bank (New York, NY)
- …projects Maintain awareness of current regulatory/industry trends impacting the Bank's operational risk management program or practices. Maintain familiarity ... RISK FRAUD OVERSIGHT MANAGER II WHAT IS THE OPPORTUNITY? Operational Risk Management (ORM) is responsible for providing independent and objective oversight of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …can clearly convey the status of security and related issues surrounding enterprise risk management decisions to all levels of the organization including ... US Ops position has responsibility for the development, implementation and management of security policies, standards, evaluations, roles and corporate awareness.… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to developvalue-added ... Development and Technology Organization. Thisposition is responsible for providing strategic program leadership, technical expertise, and project management in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Real Estate; Digital, Data and IT; Finance and Tax) and complex and high- risk supplier contracting. Relationships This job reports to the Managing Assistant General ... contracting and recommend best practices and solutions Proactively conduct comprehensive risk assessments to identify potential legal and operational risks within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory submissions to FDA and Health Canada. Relationships Reports to Management in Regulatory Operations and works cross-functionally with internal departments ... on Regulatory Affairs related issues. Essential Functions With direction from management participates on cross-functional teams focused on the planning and execution… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Manager, Employee Relations, is pivotal in ensuring consistent and thorough management of Employee Relations processes (including corrective action) across the ... business areas of support. They are responsible for consulting with management on best practices for coaching, performance and behavioral concerns while ensuring… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary point of escalation for Medical ... the Medical Review Team. Relationship Reports directly to Head of PV Case Management . This role involves the oversight of case handling activities across the… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Management , Pharmaceutical Process Development, Process Scale Up, Program Risk Management , Project Planning, Protein Characterization ... for biologics pipeline programs. Strong capability in managing evolving timelines, program risks and mitigation strategies. In-depth knowledge in upstream cell… more
