- Novo Nordisk Inc. (Plainsboro, NJ)
- …(LPPC), Graphic Designers, Marketing and Supply Chain. Relationships Reports to labeling management in Regulatory Operations (RO), engaging with key ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...to final printed pharmaceutical labeling for launch and lifecycle management projects guided by company content of labeling, FDA… more
- 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
- 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)
- …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
- 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
- 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)
- …executiveOncology sales, marketing, or consulting within the biopharmaceutical industry.Project management in commercial operations .Experience leading teams and ... 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
- Genmab (Plainsboro, NJ)
- …and tactical leadership across all clinical pharmacology and quantitative sciences operations including governance oversight, functional risk management , and ... 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
- 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
- Merck & Co. (Rahway, NJ)
- …and keeping abreast of the changing regulatory landscape.Strong leadership, change execution, and financial management skills including budget forecasting ... frameworks such OSHA, OHSAS 18000, EPA, ISO, NFPA, GMP.Strong leadership, talent management , change execution, and financial management skills.Readily and… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence ... sheet, income statement reviews and supplementary information) to the SVP of Finance & Operations and VP of Finance and Supply Chain prior to submission to Danish HQ… 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …calibrations, instrumentation, automation PLCs, VFDs and electrical practicesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg ... myeloma.Legend Biotech is seeking Metrology Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible… 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
- 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
- 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
- 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
