- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …key focus will be the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and ... objectives set forth by the Study team.The Clinical Study Manager role is primarily a tactical study delivery role,...functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, ... and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and successful ... procurement activities.- Contract Management for contracts requiring internal approval and/or external approval (CMO, requests over $100k) is required. A full… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, ... to Clinical Operations on site issues. Contributes to development of CSR. External collaboration: Consults with internal experts and external KOLs for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development ... and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... optimizing the defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... define priorities.Anticipate upcoming tasks based on the submission timelines.Perform quality control checks and coordinate comment resolution with publishing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …batch records, forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, ... an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Operations Supervisor / Sr. Operations Supervisor (2nd shift) as part of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management, will be ... as appropriate.Work with the Global Training Office to create a CRO Alliance Manager account within our learning management system (LMS) and maintain the curriculum… more
- Insmed Incorporated (Bridgewater, NJ)
- …of raw materials, components and services consistent with specified levels of quality , delivery, price and total cost. This position will support the Associate ... Director, Supply Chain & Logistics in managing a network of external manufacturers, maintain plan/schedules, conduct supplier meetings and managing inventory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in ... effort will have a focus related to industry available cell therapy unit operations to be incorporated with an automation platform that integrates with MES systems… more
- Merck & Co. (Rahway, NJ)
- …our Research & Development Division -Scientists, Maintenance, Automation, Plant Operations and Safety), Engineering Firms and Vendors to progress deliverables. ... will function as the technical/engineering process lead engineer/project design manager with prior experience supporting Biologics, Vaccine and/or Sterile Projects.… more
- Merck & Co. (Rahway, NJ)
- …(SCIS) Systems Coordinator is a project and system management role within SCIS Operations that reports directly to the Director of SCIS Business Systems. The Systems ... In addition, the Systems Coordinator will assist with maintaining data quality within our publication management system. The ideal candidate will possess… more
- Merck & Co. (Rahway, NJ)
- …of the SDLC, excellent communication and collaboration skills, and a focus on quality and customer satisfaction.The Release Manager is responsible for the ... SAP Platform team has an opening for a Release Manager with experience in coordinating and managing releases, knowledge...solution being released is reliable and meets the necessary quality standards adhering to the IT release calendarSupport all… more
- Merck & Co. (Rahway, NJ)
- …of the following: leading distributed teams which are comprised of both internal and external resources located on and offshore; manager project in Agile (Scrum) ... with project plans and mitigate risks.Facilitate cross-functional work teams including external vendors to define project scope and objectives, develop preliminary… more
- Merck & Co. (Rahway, NJ)
- …include: Key Responsibilities PMO owner and steward of "Development Project Manager " user persona; accountable for defining business process user stories and ... process.PMO owner for the training forum; accountable for curating and defining a quality annual calendar of topics that achieve the purpose and goals of the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple functions, multiple locations and across 2 companies. Internal: QC Team, Quality Team, Deviation Investigations Team, Raritan SLT. External : Global MSAT ... to Vein Time Reduction as part of the Technical Operations team based in Raritan, NJ Role Overview The...to vein time and work closely with internal and external stakeholders. Key Responsibilities Strategic Process Improvement Planning: Develop… more
- Amazon (New York, NY)
- …The Principal Program manager will be interfacing with the Finance, Procurement, Operations , Supply Chain and Transportation teams and External as well as ... millions of items every day across the globe. Amazon External Fulfillment in AFT Organization provides fulfillment technology services...while continuously innovating new solutions. As a Principal Program Manager , you will have a dual role. On one… more
- Kelly Services (Warren, NJ)
- …We are proud to offer a **direct hire** opportunity to work as a ** Quality Operations Manager ** located in **Warren, NJ** . **Shift: Monday-Friday, ... onsite** **Pay: $90k max (salary dependent on experience)** The Manager of Quality Operations leads...in escorting and providing information to Regulatory officials during external audits. Support supplier and internal audits, as needed.… more
- Bausch Health (Bridgewater, NJ)
- …regulated environment. Reporting directly to the Senior Manager of Quality , this position collaborates closely with External Manufacturing Organizations ... lives with our health care products. The **Senior Specialist, External Manufacturing Quality ** plays a crucial role...with the Document Management system for the EMQA US Operations . + Assist quality management in all… more
