- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as external investigators is expectedThe CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and ... and associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... services/tasks in support of the planning and implementation of quality driven clinical trials, in line with...exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records.; May be required to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; ... services/tasks in support of the planning and execution of quality driven clinical trials in line with...Provides system and device expertise to train and support clinical trial sites Ensures ongoing collection and review… more
- Eisai, Inc (NJ)
- …providers and managing service provider business relationships in alignment with global strategies. Review and approve Clinical Quality Assurance audit plans ... to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities...lead and support activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QC Data Reviewer as part of the Quality team based in Raritan, NJ. Role Overview ... The QC Data Reviewer is an exempt level position responsible for reviewing...position responsible for reviewing all data produced by the Quality Control Lab during In-Process and release Drug Product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. Role ... Overview The Lead QC Microbiology Data Reviewer is an exempt level position with responsibilities for...the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of ... clinical trial activities, ensuring adherence to timelines, budgets, project, and quality plans, and relevant ICH/GCP Guidelines Review protocols to ensure… more
- Catalent (Philadelphia, PA)
- …authorities.The Director of Quality is responsible for providing leadership and Quality Management support within each of the Clinical development supply ... and interpretation of regulations/guidelines related to GXPs focused mainly on good clinical trials, as applicable. Writes and approves Quality unit SOPs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... Manage multiple and complex cross-functional projects with many stakeholders. Support other quality systems activities, as needed. Support drafting, review and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan ... with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference ... and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the ... centered around rare diseases and immune disorders. Summary The Manager, Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support and may… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate hasexperience working in an aseptic manufacturing facility, preferably in quality assurance,manufacturing compliance, clinical quality , or cell ... of corrective and preventive actions, as necessary. Supports internal/external audits. Supports Quality risk assessment teams. Review /approve documents as a … more
- Novo Nordisk Inc. (South Houston, TX)
- …for the "at risk" diabetes patient population (Eg, providers, care coordinators, quality , population health, clinical pharmacy) Educate providers on strategies ... Diabetes Education Program strategy. Interacting with health system KOLs, providers, quality , care coordinators, advanced practice providers, and the like to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … support in clinical manufacture or NPI is preferred. Experience in clinical quality , method development, cell banking, or Research & Development is ... Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role Overview The...materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , MSAT or ... seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview The...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... Lead (2nd or 3rd shift) as part of the Quality team based in Raritan, NJ. Role Overview The...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …must have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... QA Investigations Supervisor (2nd shift) as part of the Quality team based in Raritan, NJ. Role Overview The...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Merck & Co. (Rahway, NJ)
- …role is accountable for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, company policies ... and procedures and-with quality standards internally and externally.Under the oversight of the... standards internally and externally.Under the oversight of the CRD( Clinical Research Director) / Director, Clinical Research,… more
