- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of concern and either resolve, propose solutions, or bring to the attention of the operations lead of study team lead . Coordinate and liaise with Daiichi ... involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and vendor selection process ...performance and quality metrics and share with study team, Operations Program Lead , and Sr. Director for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain effective communication ... DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …flow of documents in order to meet submission timelines. The Director will develop the process , tools and systems needed to build a core dossier for global ... and immune disorders.Summary The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier planning team and leading… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies review and ... diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global… more
- Tris Pharma (Monmouth Junction, NJ)
- …Test Results for Pharmaceutical ProductionStrong working knowledge of pharmaceutical investigation process and ability to conduct, lead and/or draft effective ... Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports, oversees… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …demonstrate that processes are in control and ensure required compliance levels. Implement and lead the process to regularly review and assess KQIs at the ... in collaboration with business functions. Support local inspections with adequate systems and process support.Support through open and effective communication… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations . Experience in training, process improvement, and project management ... with process mapping tools (eg, Visio, Power Point), training systems , and metrics dashboarding preferred- Understanding of industry trends (eg, regulatory,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to meet GRA needs and enable visibility across regions and sub-functionsPartner with the Process Excellence Lead and others to identify process improvements ... will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage day-to-day operations of MCT technology/digital projects as business function lead , in collaboration with Digital Strategy & Innovation, to align on goals ... and external customers and contributing to training and knowledge sharing activities- Lead the standardization and improvement of MCT operations ; responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of External Vendors by engaging with key cross-functional stakeholders (Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing data collection, data ... management activities by managing Program / Therapeutic level external data collection process , study requirements as well as the overall process .Accountable for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …external vendors by engaging with key cross-functional stakeholders (Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) for establishing data ... bid defenses and/or vendor selections and work alongside DS Procurement and DM operations to qualify preferred data vendors to ensure DSI data collection and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to experiment with us? The Position The Diagnostics and Precision Health Lead will be responsible for developing and implementing a diagnostics and precision ... to finding patients. Relationships Reports to Integrated TA Strategy Lead . Collaborates closely with cross-functional teams, including therapy area marketing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance and Operations works closely across the organization to guide enterprise-wide...developing IT solutions. In the support role of existing systems , this role provides knowledge, testing, documentation, Service Level… more
- Merck & Co. (Rahway, NJ)
- …the EBRGs globally.- Lead facilitation of the monthly EBRG Infrastructure and Systems Strategy Council and ensure the strategies developed by the Council are ... and inclusive culture.-This role has the following primary roles and responsibilities: Lead facilitation of the monthly EBRG Executive Leadership Council meetings… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Operations Process Trainer (2nd shift) as part of the Technical Operations ... team based in Raritan, NJ. Role Overview Operations Process Trainer will be responsible for performing process training activities for Operations team… more
- Merck & Co. (Rahway, NJ)
- …financials related to project execution and closeout.- The incumbent will also lead the contracting/PO process for goods (software/product licenses) and services ... the EIT SAP Platform Team, the Financial and Budgeting lead will have responsibility to track and manage TCO...external POs in support of SAP Platform initiatives and operations .Managing collection and tracking process for resources… more
- Insmed Incorporated (Bridgewater, NJ)
- …Chemistry) will have responsibility for the management of API/Intermediate/RSM manufacturing operations at Insmed's CMOs including tech transfer, process ... the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic… more
- Merck & Co. (Rahway, NJ)
- …and interfacing with the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Operations ... with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems , etc.Experience working in an environment… more
- Merck & Co. (Rahway, NJ)
- …Company's network of GMP pilot facilities, commercialization facilities, and process development labs, across our research division and manufacturing division, ... the development/commercialization space and an associated standardization of the digital systems and associated support services that enable the execution of these… more
- Merck & Co. (Rahway, NJ)
- …the EIT SAP Platform Team, the EIT Indirect Tax Technical Delivery Lead will assume responsibility for leading a team of Software Engineers, developing ... and build key relationships with the Finance Value Team Lead , and the Tax Management Product and Product Line...will gain a deep understanding of the business processes, systems , and data that support strategic processes and programs… more
