- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global PV regulations for individual case safety reporting, periodic reporting and risk management . Develops and implements strategic initiatives for global ... address, escalate issues requiring attention or resolution, and proactively drive operational excellence and continuous improvement. Oversees the management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs), ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...the BPQLs and relevant business partners.Support the R&D Quality Operational Excellence activities, which prioritize and focus on the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …availablePerform work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and ... Out of Tolerance (OOT) situations and other technical documentationConduct basic risk mitigation options and advanced troubleshooting to identify root cause and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational ... Research, Research, Informatics Services, Project Management and Operational Management . The...architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& compliance objectives Works collaboratively with NNI's cross-functional ethics and compliance risk management stakeholders to develop healthcare ... risk mitigation efforts in alignment with the E&C's risk assessment, management and mitigation program. The...E&C and leadership regarding the progress and effectiveness of risk mitigation plans Delivers ethics & compliance … more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management ...systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Risk Evaluation and Mitigation Strategy (REMS) including the management and oversight of systems supporting these processes. It involves coordinating and ... the Department At Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest… more
- Genmab (Plainsboro, NJ)
- …their skills and knowledge on process management & improvement, strategic & risk management planning, change management and stakeholder management . ... the team that is in the leading role in the planning of operational excellence, strategic planning, and innovation implementation for the Global Clinical Drug Supply… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …completed in compliance and meets Novo Nordisk's business standards Risk Management : Assessing and mitigating risks associated with operations, implementing ... team collaboration, training and development, employee engagement, and recognition Change Management : Identifying areas for improvement in operational processes… more
- Genmab (Plainsboro, NJ)
- …of corresponding actions and processes.Knowledge/SkillsExcellent knowledge of security and risk management frameworks and standards (eg NIST, ISO).Excellent ... having a detailed and thorough understanding of the underlying operational and commercial business processes. The support of our...VP and Global Head of Information Security and IT Risk & Compliance , playing a strategic role… more
- Genmab (Plainsboro, NJ)
- …pipeline candidate drugs. This individual will provide strategic input and ensure operational execution of global (and US) submission activities. The individual will ... Profile). For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health… more
- Merck & Co. (Rahway, NJ)
- …supplier relationship management , to promote continuous improvement in operational efficiency, cost-effectiveness, and risk mitigation across the global ... Diversity and Environmental Sustainability, in alignment with the company's overarching ambitions. Risk Management : Develop and enforce risk mitigation… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... to ensure timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic goals that advance functional impact.The… more
- Merck & Co. (Rahway, NJ)
- …(Planning) organization is the key interface between clinical development teams and the operational /executional arms within the business. - - This role works with in ... the Planning Execution and Inventory Management Section of the GCS Planning organization.- W orking...Supplies Project Manager ( IM CSPM) creates strategic and operational plans associated with the downstream activities of clinical… more
- Merck & Co. (Rahway, NJ)
- …a core member of the ExM Operations team, which includes senior and operational leaders, the Associate Director will provide financial analyses and guidance to ... support decision making across vendor selection, contract negotiation & review and risk assessments and will be the primary point of contact to ensure financial… more
- Merck & Co. (Rahway, NJ)
- …is the key interface between clinical development teams and the operational /executional arms within the business.-- - - Working independently, the Protocol ... Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities associated with clinical supplies for their assigned… more
- Merck & Co. (Rahway, NJ)
- …development through the implementation of the business solution using the Capital Management stage gate process with varying degrees of responsibility and will ... exhibit sound leadership and exemplary partnership, communication, and vendor management skills.- They are expected to develop and maintain advanced technical… more
- Merck & Co. (Rahway, NJ)
- …is the key interface between clinical development teams and the operational /executional arms within the business. The Program Clinical Supplies Project Manager ... independently, the Program Clinical Supplies Project Manager designs strategic and operational plans for all clinical supply activities associated with the clinical… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... launch.- The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build a culture… more
- Merck & Co. (Rahway, NJ)
- …of containment philosophies for potent compoundsExperience with Process Safety Management , Industrial Hygiene/Potent Compounds and Ergonomic Risk Assessment ... development through the implementation of the business solution using the Capital Management stage gate process with varying degrees of responsibility and will… more
