- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond ... we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and...providers for Eisai's R&D functions. This role will ensure compliance with key processes and manage the outsourcing team.… more
- Novo Nordisk Inc. (Atlanta, GA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ownership...services/tasks in support of the planning and implementation of quality driven clinical trials, in line with… more
- Catalent (San Diego, CA)
- Quality Assurance Associate , Clinical ...committed to a Patient First culture through excellence in quality and compliance , and to the safety ... Catalent Pharma in San Diego, CA is hiring a Quality Assurance (QA) Associate , Clinical ...scientific reasoning ability to identify aberrant data and potential quality / compliance concerns escalating to management.Excellent written and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …approach, leveraging competencies, tools, and technology. Maintains responsibility for quality , performance, regulatory compliance , and patient safety related ... Executes all relevant services/tasks in support of the planning and quality delivery of clinical trials in line with established targets and metrics including… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Insmed Incorporated (Bridgewater, NJ)
- …the clinical study team (CST) with the responsibility to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ... the TMF to Insmed at end of study. Partner with Quality Assurance team to help clinical study team with audits/inspections for CRO/vendors in preparation of… more
- Merck & Co. (Rahway, NJ)
- …scientists, engineers, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, ... Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply.-Education Minimum Requirements:- Associate 's Degree in Chemical Engineering,… more
- Catalent (San Diego, CA)
- Quality Assurance Associate I, ManufacturingCatalent Pharma Solutions in San Diego is currently hiring a Quality Assurance Associate I in our QA ... Manufacturing group. A QA Associate I must be familiar with applicable GMPs. This...committed to a Patient First culture through excellence in quality and compliance , and to the safety… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell therapy. A minimum of ... Corrective and Preventive Actions (CAPA) process, and is responsible for ensuring compliance within quality systems processes. Key Responsibilities Lead the CAPA… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP Principles and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …agreements across a broad spectrum of external entities with a focus on budget, quality , compliance and in alignment with business needs Serve as a subject ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Aequor (Thousand Oaks, CA)
- …if going well ** Must be within 1hour away or 30/50 miles MCS Mfg Associate MCS Manufacturing Associate -EW Job DescriptionJob Summary The Associate of ... dynamic production environment at the Thousand Oaks Site supporting development, clinical , and launch activities. Under general supervision, employee will perform… more
- Merck & Co. (North Wales, PA)
- …safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, ... statistical analysis and high- quality data to assist decision making in ...and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance .Strategic thinking - ability… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ... ensure its quality and integrity.- Provide hands-on statistical programming support to...submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory… more
- Merck & Co. (North Wales, PA)
- …success in the assurance of deliverable quality and process compliance .Familiarity with statistics and clinical data management concepts. Preferred ... 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.MS (preferred) in Computer Science, Statistics, Applied Mathematics,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), ... assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company ... in the treatment of multiple myeloma. Legend Biotech is seeking an Operations Associate (2nd Shift) as part of the Technical Operations team based in Raritan,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …gowning training tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company ... in the treatment of multiple myeloma. Legend Biotech is seeking a Operations Gowning Associate as part of the Technical Operations team based in Raritan, NJ. Role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effective, holistic continuous improvement and problem-solving program to improve safety, compliance , cost, process stability building quality and efficiency ... in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Associate OpEx Engineer as part of the Technical Operations team based in Raritan,… more
