- Merck & Co. (Rahway, NJ)
- …RIM-based global content source management solution and function as BSOLead the Change Management and Business Process activities to drive adoption of the ... of improvement initiatives including business process design, coordination of IT activities, change management and trainingPartner with QA and Standards to… more
- Merck & Co. (Rahway, NJ)
- …knowledge in QbDRequired Skills: Applied Engineering, Applied Engineering, Capital Management , Change Management , Chemical Process Development, ... Manufacturing Scale-Up, Process Improvements, Product Commercialization, Product Lifecycle, Product Management , Regulatory Requirements, Results-Oriented, Social Collaboration, Stakeholder… more
- Merck & Co. (Rahway, NJ)
- …products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. The role will ... continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying process inefficiencies… more
- Merck & Co. (Rahway, NJ)
- … Management and web applications Required Skills: Business Strategies, Change Management , Digital Brand Strategy, Digital Marketing, Direct Marketing, ... supporting m ulti-national corporations- Minimum of 5 years of people management experience required Strong understanding of regulatory requirements and… more
- Merck & Co. (Rahway, NJ)
- …CQV and IT teams.Support establishment of GxP systems in the facility: Change Management , Maintenance protocols, Calibration procedures, Training, and SOPs for ... with flexible operating suites, which can adjust as the clinical pipeline demands change . It is capable of meeting all historic, currently existing, and cutting-edge… more
- Merck & Co. (Rahway, NJ)
- …with internal and external stakeholders.Required Skills: Applied Engineering, Change Management , Combination Products, Compliance Packaging, Cross-Functional ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more
- Merck & Co. (Rahway, NJ)
- …and external stakeholders. Required Skills: Biopharmaceutics, Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more
- Merck & Co. (Rahway, NJ)
- … Management , Analytical Thinking, Benefits Administration, Benefits Planning, Change Management , Compliance Reviews, Financial Review, HR Analytics, ... benefits committee approvals, financial oversight, reporting, plan audit(s) validation, regulatory filings, benefits education/outreach) Primary responsible party for daily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submissions Understand manufacturing changes to ensure compliance with appropriate change control systems/process and support regulatory filing strategy ... rare diseases and immune disorders. We are currently seeking a Technology Management Monoclonal Antibody (mAb) Intern for Summer 2026. This full-time position works… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …where your distinct perspectives and expertise are valued as we work together to change lives for the better. The Position The Associate Director, Media Relations & ... Issues Management is accountable for establishing and leading Novo Nordisk's...Affairs, Legal, Finance and Investor Relations, Clinical, Medical and Regulatory , plus other cross functional teams as needed. Key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …improvement; develop and track metrics to evaluate impact of initiatives; partner with Operational Change Management team to develop change management ... and Care gap. Partner with technology teams on platform management and as pilots become successful, scale up initiatives...of related experience working in data analytics in commercial, regulatory , market access or medical affairs function in a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …medical affairs, market access and policy/advocacy (MAPA), Global Commercial, regulatory affairs, other relevant NNI departments. Essential Functions Identify, ... recommendations for ongoing improvement. Identify and implement actionable improvements Budget Management : Ensure effective management of the marketing budget to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …validate 340B Program processes as well as MFP refund processes, oversee general management , and modifications in the event of regulatory changes. Supports ... as Maximum Fair Price ("MFP") effectuation requirements consistent with regulatory requirements, NNI policies and procedures and Sarbanes-Oxley regulations.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …who are strategic and bold thinkers, passionate and dedicated to driving change in Rare Disease, patient focused, strong collaborators, and inclusive leaders, as ... drive patient initiatives. Requires experience and collaboration with the Medical, Regulatory and Legal review process. Essential Functions Develops a deep… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …processes, including inbound, outbound, storage, and replenishment.Work with inventory management systems and execute cycle count and reconciliation activities to ... the optimization and efficient utilization of the warehouse space. Assist in regulatory inspections, perform safety and quality audits, and answer relevant questions… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the team to be effective.Strong track record in executing effective project management in cross-functional teams within IT, clinical, regulatory , pharmaceutical ... Manufacturing Execution Systems Lead and will be responsible for providing project management support to the development and administration of EBR and digital… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Engineering is a strategic and operational leader responsible for the management , development, and performance of all engineering operations across Raritan Carvykti ... infrastructure, equipment, and systems support business goals and comply with safety, regulatory , and sustainability standards. This position is a key member of the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Actions (CAPA's) are developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting ... in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within facility and serving as… more
