- Eisai, Inc (Nutley, NJ)
- …collating information and providing updates to the CRO Initiates, tracks and collates clinical trial documentation related to CSR appendices. Act as central ... clinical team for designated projects, communications, and associated documentation Document Creation and Management: Assist with creating, updating and… more
- Merck & Co. (North Wales, PA)
- …Engineering or related field with a minimum of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.MS (preferred) in ... or related field with a minimum of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. Required-Experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …recommendations for Changes and process improvements.Provide oversight, Manage Implementation and documentation of PV Safety systems Change Request supporting ... This position is also responsible for the delivery of systems , configuration and associated validation activities of Daiichi Sankyo...cross-functionally and be the voice of CSPV on key system and business process decisions, informed by a deep… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems engineering team. This role will require ... of the employees in the maintenance process, the information from SAP, the technical documentation and other data systems . With this information, the Asset /… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... for the financial management and budget development of North America Clinical Operations (NACO). Responsible for driving financial oversight across trial portfolios… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ... ensure compliance within the document management system , document storage and retention, and document issuance and reconciliation.Key Responsibilities Day to day… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of safety data between partners in relation to marketed and clinical products.Strategic Partner Management:Oversees Local/Global PV service providers responsible for ... with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs. Facilitate operational meetings… more
- Eclaro (Whitesboro, NY)
- …; make medication sheet for each client that gets injections Complete clinical documentation that meets compliance standards, medical necessity guidelines, and ... agency standards as to timeliness and accuracy of documentation Perform home/community visits as needed For client's on...work on spreadsheet Submit lab work into the REMS system If clients are overdue, reach out Fax lab… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology, immunology, or complex disease therapeutic area is a must. Working knowledge of Clinical trial data systems and/or EDC and related applications is a ... end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sterility, growth promotion, as well as other microbiological assays.Utilize electronic systems (LIMS) for execution, documentation , review of testing.Perform ... exempt level position with responsibilities for reviewing microbiology data and documentation generated from the Environmental Monitoring program, drug product and… more
- Aequor (Athens, GA)
- …in accordance with study protocols, completes and maintains appropriate documentation associated with all job assignments, and provides equipment sanitation ... enrichment materials. Maintains, adjusts, and repairs animal pens, feeders, drinking systems , and livestock handling equipment. Performs cleaning and sanitation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Exchange, and Dashboards. And in the R&D space including but not limited to clinical trial management system , drug labeling, and learning management system ... the ongoing production support of Commercial and R&D IT systems and applications. The individual in this role owns...contact of R&D areas including but not limited to clinical trial management system , drug labeling, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Inspections for QC.Perform peer review/approval of laboratory data.Utilize electronic systems (LIMS) for execution and documentation of testing.Create, ... management or leadership experience is required.Experience working with Quality systems is required.Experience with quality support in clinical /commercial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …area readiness activities/processes, aiming to support start of a personalized clinical cell therapy site meeting cGMP requirements. This individual will serve ... and will assist with utilization and improvements of Legend's ERP system .Key Responsibilities Distributes process materials (raw materials, kits, etc) to the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes ... GMP decisions.Independently resolves problems through the use of quality systems .Develop improvement ideas and independently implement associated solutions.Support QPIP… more
- Merck & Co. (Rahway, NJ)
- …company's biologics pipeline. We work closely with colleagues in Discovery, Pre- clinical and Early Development to rapidly develop manufacturing processes for diverse ... biotherapeutics, and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and the development and… more
- Genmab (Plainsboro, NJ)
- …purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both ... responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice ... information in a clear, concise, format according to Good Documentation Practices (GDP).Perform tasks on time in a manner...tasks on time in a manner consistent with quality systems and cGMP requirements.Work in a team based, cross-functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …improvement projects within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ... drafting of standard operating procedures, change controls and other documentation .Manage cross-functional projects with many stakeholders.Perform tasks in a manner… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be ... management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production… more
