- 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)
- …required- People Leadership skills preferred- Demonstrated ability to recommend and lead process improvement and innovation initiatives preferred Licenses and ... This position is accountable for comprehensive Payroll Management with a focus on Systems and Process Enhancements/Innovation and relies on deep expertise in… 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 a ... 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)
- …(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)
- …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)
- …CRO study close-out. Liaise with internal Functions to ensure drug destruction process is implemented. Liaise with CRO to support database lock and review ... TLG before and after database lock.Ensure DS internal tracking systems are updated (eg Global Project Management System, GPMS)....resolve or bring to the attention of the Delivery Lead . Coordinate and liaise with Daiichi Sankyo QA on… 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)
- …existing diversity and patient voice related portfolio of platforms, tools and systems .Design, lead and implement the GCO delivery framework for diversity ... new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to...key responsibilities are within and for GCO to: 1) Lead and implement the establishment and oversight of an… more
- Aequor (New Brunswick, NJ)
- …to, those identified during the annual strategy/portfolio planning and integration process . Key Responsibilities: Lead and ensure successful deployment of ... onsite Position: Project Manager, Global Supply Chain Strategy & Business Operations , Strategic Initiatives Location: New Brunswick, NJ preferred (but flexible to… 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)
- …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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to experiment with us? The Position The Business Knowledge Management Lead will be responsible for the development of a robust knowledge management system ... for sustained organizational benefit. Relationship Reports to Business Excellence Lead . Collaborates with cross-functional teams, including marketing, analytics, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the people who need them most. The Position As the Manager, Content Operations , you will support Novo Nordisk's strong commitment to its Omni-channel Customers ... them with optimal solution options. Through this role, the Manager will lead definition of business requirements and technical implementation plans in collaboration… 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)
- Job DescriptionAs a Site Reliability Engineer (SRE) Architecture Lead , you will drive the technology strategy, architecture, and operational excellence of critical ... key responsibilities of the Site Reliability Engineer (SRE) Architecture Lead , highlighting their role in driving technology strategy, implementing SRE… 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)
- …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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Manufacturing Lead Operator as part of the Technical Operations team based in ... purification, aseptic processing, and cryopreservation using appropriate techniques. Perform process unit operations according to standard operating procedures… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Key Responsibilities Lead and supervise multiple units within the CAR-T process operations (ie component preparation manufacturing, MFG support operations ... standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of… more
