- Merck & Co. (Rahway, NJ)
- …execution throughout Global Regulatory Affairs and Clinical Safety through change management .-Develop, implement and report process objectives and key ... process management organization capabilities (eg, lean six sigma, change management , executive-level facilitation, project management , negotiations,… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, project management , change management , and risk management ... reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the relevant support teams for their domain area. This includes managing service contracts, change management , and SLA management . The GSM partners with ... and champion the day-to-day operation of the lifecycle of Incident, Problem, and Change Management . Communicate and interface with matrix teams, IT leadership,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Manager as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe CAR-T Operations Manager is an exempt level position working within...individual will also oversee the hiring, development, and performance management of staff, and assign personnel to execute daily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and escalate significant issues and findings in a timely manner. Study Operations Oversight Management :Contribute to the oversight of Qualification and Training ... to risk-based monitoring (RBM) and Central Monitoring.Responsibilities:CRA Monitoring Oversight Management :Support monitoring oversight strategy to ensure quality and compliance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …maintenance management systems (CMMS)Quality Management knowledge, including Change control, Deviation, and CAPA's.EHS and regulatory standards (eg EPA, ... is seeking a Supervisor, Maintenance (3rd shift) as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Supervisor, Maintenance is an… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to: support to manufacturing equipment projects, cost-improvement initiatives, asset management , reliability, and business operations .Support facility project ... and strong communication skillscGMP manufacturingMaintenance, facilities and utilitiesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a future focused approach, leveraging competencies, tools and technology, and with change management skills. Relationships Reports into NACD Therapy Area Head. ... , team collaboration, training and development, employee engagement, and recognition Change Management : Identifying areas for improvement in operational… more
- Genmab (Plainsboro, NJ)
- …skills and knowledge on process management & improvement, strategic & risk management planning, change management and stakeholder management . Leading ... internal and external stakeholders, including GCDS Operations , GCDS Systems, Development Operations , Portfolio & Project Management , and CMC. You are skilled… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …events including but not limited to Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA's.Ensures regulatory and ... myeloma.Legend Biotech is seeking Facility Engineer as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Investigations (QI's). He/she supports CAPAs (Corrective and Preventive Actions) and CCs ( Change Controls) within quality management systems. You will also write ... an Asset Reliability Engineer as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Asset...work instructions that are part of the QMS (Quality Management System).You combine the knowledge of the employees in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …speakers, and as needed engagements with full speaker bureau Contracted HCP operations management : Manages Speaker Engagement Plans, monitors metrics to identify ... management of non-HCP promotional programs, and overseeing the management of speaker and HCP program operations ...Pharm Field Sales, Managed Care, Trade and Government, Medical, Regulatory , Legal personnel and may advise Global Teams with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …skills in designing and implementing innovation/improvement initiatives, including the required change management We commit to an inclusive recruitment process ... The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations , the Associate Director...(SOWs). The AD will be responsible for providing supplier management support and oversight to the North America CMR… more
- Genmab (Plainsboro, NJ)
- …futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment ... Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS) Operations Team in Princeton or Copenhagen within commute distance from our office… more
- Genmab (Plainsboro, NJ)
- …providers.The focus of this role will include stakeholders in the business domains Field Operations , Medical & Regulatory Affairs and US and Japan Market and ... and Genmab Security Operations TeamBusiness leaders (eg, VP Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers within IT&D, such as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drives the long-term strategic direction of Novo Nordisk Inc. (NNI)/North America Operations (NAO) and leads all US commercial efforts for Novo Nordisk's Rare ... Market Access and Public Affairs (MAPA), Portfolio Strategy, Commercial Excellence, Regulatory Affairs, and other relevant NNI departments to ensure alignment of… more
- Genmab (Plainsboro, NJ)
- …informatics, Research data products, Lab systems automation, Development Operations , Pharmacovigilance, Regulatory , integration and Data visualization.At ... futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drives the long-term strategic direction of Novo Nordisk Inc. (NNI)/North America Operations (NAO) and leads all US commercial efforts for Novo Nordisk's Rare ... Lead will assess the current landscape, develop strategic plans, and drive impactful change to make a tangible difference in the treatment of rare diseases.… more
