- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documentation.Vendor Management -supports Person in Plant (PIP) activities when packaging operations for DSI are in- process . Supports investigational product ... with CSO project Management LeadResponsible for the Clinical Label Development process which includes creation of master label text, translations, and label… more
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …their parts of the Research & Development division.The Associate Director, PMO People & Process Lead , is a unique role that will be heavily client-facing, ... to the PMO/ IPP resources, while identifying improvements to existing available resources. Lead for user experience / process improvement initiatives across PMO… more
- Merck & Co. (Rahway, NJ)
- …significant depth and breadth of scientific, technical, and operational experience to lead and support facility operations , process development activities, ... is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain...drive overall success of the pilot plant. The Facility Lead position reports to the Director of Operations… more
- Merck & Co. (Rahway, NJ)
- …achievement of immediate and future state business objectives.The SAP Material Handling IT Lead will play a critical role in the delivery and global design integrity ... deliver SAP solutions across the organization.As the SAP Material Handling IT Lead you will be responsible for:Managing Material Handling solutions through all… more
- Merck & Co. (Rahway, NJ)
- …at a global scale, supporting our business in over 130 countries.The Technical Lead role will provide solution architecture and technical leadership for a team of ... will:Build key relationships with Facilities Management leadership and IT colleagues to lead the delivery of our business solutions.Gain a deep understanding of the… more
- Merck & Co. (Rahway, NJ)
- …you will:Build key relationships with Global Security leadership and IT colleagues to lead the delivery of our business solutions.Gain a deep understanding of the ... business processes, systems , and data that support strategic processes and programs...areas of growth and technical development.Key Responsibilities:As the Technical Lead , assess the current state solutions and develop a… more
- Merck & Co. (Rahway, NJ)
- …data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations , ... inspection management activities. The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic… 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
- Merck & Co. (Rahway, NJ)
- …teams to integrate the file transfer system with other applications and systems . Develop and maintain documentation related to the file transfer system, including ... industry trends and best practices related to file transfer systems . Provide technical support and training to end-users and...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- …are incorporated in vendor roadmap that not only supports current process /needs but also future vision and innovative technology options.-Manage platform demand ... during the release lifecycle by bringing users during planning phase of the process , understand end user needs and day in life.Oversee and help to complete… 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
- Merck & Co. (Rahway, NJ)
- … systems and associated infrastructure.- Responsibilities include the following:The process /facility engineer role at the Associate Director level will serve as ... critical activity workstreams to enable facility startup. The selected candidate is expected to lead and mentor a team of process /facility engineers and foster a… 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
- 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
- Eisai, Inc (Nutley, NJ)
- …security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution for the ... incidents.Conduct annual tests and address vulnerabilities.Analyze threat data and lead hunting efforts.Deploy standards, conduct training, and track KPIs.Define… 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
