- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, ... New Jersey. Role Overview The Quality Systems Lead role is an exempt level position with...2 years of leadership experience is preferred. GxP Quality System knowledge, including relevant regulations and guidances (eg 21… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary The Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative Clinical Pharmacology ... application of QSP within Oncology/Immuno-Oncology. ResponsibilitiesDevelop and apply Quantitative Systems Pharmacology (QSP) models to address drug-discovery and development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems ... supporting GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review issues log, develop risk mitigations strategies and ensure all systems are operating well as designed. Ensures compliance with internal controls ... and accounting policies. Optimizes Financial Disbursement technology through system upgrades and other proven automation practices to build efficiencies and stay… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the administration and operational support of Daiichi Sankyo's Veeva CRM system within IT. They'll collaborate with various sales and marketing customers to ... API requirements (no development experience required) in and out of Veeva CRM system .- Documentation: Document various system related documentations such as … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Deliver the development and implementation of Research & Development (R&D) informatics systems and programs to support the business functions of Daiichi Sankyo (DS) ... informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver applications solutions to meet business… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... performance leading to sustained right first-time execution Knowledge of LMS system Supports the maintenance and reporting of quality training metrics Support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ManagementAssist the Director in the implementation of new processes, procedures and/or systems , including the current global Learning Management System [LMS], ... they relate to Company-wide trainings and external/global trainings, as appropriate.Maintain systems and document training curricula to ensure that only current… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The incumbent must have understanding of state of the art technology systems necessary to complete tasks and allow decision making.Responsibilities- Support Head, ... ensure New Hire has a sufficient access to the system and information to do that work.- Review the...experience desirable, including oversight and administration of validated electronic systems such as LMS or other quality management … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and maintenance- Evaluate, assess and enhance DSI computing environment system . Responsibilities include: continue assessing DSI new computing environment ... system for programming and analysis efficiency, identify ...structures and set-up preferredDaiichi Sankyo, Inc. is an equal opportunity/ affirmative action employer. Qualified applicants will receive consideration for… more
- Insmed Incorporated (Bridgewater, NJ)
- …and maintenance. The Manager will also serve as business owner for all computerized systems and will serve an active role in CSV activities including, but not ... protocols and reports).Serves as the analytical development business owner for computerized system . As the AD Business owner, responsibilities will include, but not… more
- Lundbeck (Philadelphia, PA)
- …In collaboration with Payer Account team, discuss payer coverage policies and system protocols with key stakeholders within Health Systems /IDNs, bringing in ... and monitor strategy for identified strategic accounts (eg, health systems , IDNs, academic institutions, fellowship programs). The key external stakeholders… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to the QC laboratory and ability to identify gaps in processes or systems . Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) ... and lab management software system (LIMS). Prepare documents and coordinate Sample shipment (internal...reviews and regulatory inspection processes. Working knowledge of Quality systems . Experience in management of retain samples using electronic… more
- Insmed Incorporated (Bridgewater, NJ)
- …support and promote collaboration internally and externally to ensure all systems , processes and their outcomes comply with applicable international and national ... the following:Facilitate and maintain a risk-based and scientific-based quality system to support Good Pharmacovigilance Practice (GVP).Establish and maintain… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …and replenishment. This individual will also work with inventory management systems and execute cycle count and reconciliation activities to ensure inventory ... guidelines. Experience using material handling equipment, SAP, or similar inventory management system is required. Cold supply chain knowledge and fork lift truck… more
- Detroit Medical Center (Detroit, MI)
- …Type: Staff DMC University Laboratories (DMCUL) is a regional, integrated laboratory system providing services to the eight hospitals of Detroit Medical Center. DMC ... patient service centers, remote ambulatory laboratories, marketing staff, courier system and billing department. The DMC University Laboratories service area… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on request.Assist in ad hoc monitoring activities as required to ID appropriate systems , data sources, and reports that can aid in overall analysis to determine ... tables, graphing, macros, etc.)- Strong ability to ID critical systems related to the engagement of and payments to...and the provision of grants and charitable contributions- Strong system knowledge of the communication tools used by the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will provide strategic direction and leadership for the investigations management system . Working closely with the Quality Senior Manager, this position will ... for providing oversight and co-leadership of the investigation management system , including technical and performance oversight, co-managing investigation teams in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …scientific / technical problems Develops and evaluates quality processes and system standards to ensure compliance with applicable Janssen standards, industry ... Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements. Drive continuous improvement Other duties may be assigned,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global MCT policies and procedures- Define key reports and insights from MCT systems ; track and communicate key metrics- Proactively identify potential MCT system ... conference and meeting-specific Daiichi Sankyo, Inc. is an equal opportunity/ affirmative action employer. Qualified applicants will receive consideration for… more
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