- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data management expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… more
- Merck & Co. (Rahway, NJ)
- …reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking ... sites in a country.Under the oversight of the CRA manager or CRD, the person ensures compliance of study...allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships with external partners relevant to the planning and implementation of clinical trials improvement /innovation projects for NACD and Novo Nordisk ... with multiple internal stakeholders relevant to the planning and implementation of clinical trials improvement /innovation projects for NACD and Novo Nordisk (eg,… more
- Catalent (St. Petersburg, FL)
- …as well as support the clients with products that have technical opportunities for improvement . The QA Manager will act as an initial escalation decision maker ... Manager , QA (Product Development)Position SummaryThe Quality Assurance Department...Master Shipper Labels, Process recipes, various technical protocols (Pre-Commercial Clinical Packaging Protocols, Process assessment, Method Validation, Bulk Mfg… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety,… more
- Eisai, Inc (NJ)
- …Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' ... is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Catalent (San Diego, CA)
- …, Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a ... member of the Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ... records. Implement and lead CAPA site governance program. Drive continuous improvement of quality systems processes. Implement processes to ensure compliance with… 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 ... reported to management. Perform proper root cause analysis, identification, documentation , correction, corrective and preventive action, as appropriate Supports… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and ... delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ... Business Units. Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of R&D QA. Within assigned… more
- Catalent (Manassas, VA)
- …2nd Shift is responsible for creating and maintaining the Quality System documentation . Communicate any deviations to management. Assist the Quality Assurance team ... is a site based positionThe Role:Support the creation and maintenance of all documentation related to the Quality System utilizing technical writing skills to ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP environment. Reviews, ... inspection plan and record results to complete receipt process. Reviews inspection documentation (C of A or other Material Certifications) for inbound materials.… more
- University Medical Center of El Paso (El Paso, TX)
- …in implementing and supporting hospital information systems. Under Systems Manager ' supervision, provides guidance to team members on task prioritization, ... planning, and issue resolution. Assists manager in the assignment of daily work and projects...assists in addressing or escalating accordingly. Identifies opportunities for improvement to increase team's effectiveness and efficiency and develop… more
- Integrated Resources, Inc (Atlanta, GA)
- Job Title: Senior Quality Improvement RN Location: 100% Remote Duration: 3-6 months (possibility of extension) Full Remote, must work M-F 8:00 AM to 5:00 PM PST. Job ... key quality strategies that require a component of near real-time clinical decision-making. These activities may include initiation and management of interventions… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …Springs, North Carolina, United States. External US About This Role The Manager , Bioassay/Virology is responsible for contributing to key functional, tactical, and ... of the QC group at Fujifilm Diosynth Biotechnologies. The Manager , Bioassay/Virology is accountable for GMP compliant laboratory operations...is maintained in a state of GMP compliance, all documentation is in accordance with GMP, and that all… more
- FFSS- FUJIFILM Sonosite (Bothell, WA)
- Overview Senior Program Manager - Bothell, WAFUJIFILM Sonosite, Inc. -- If you are looking for work that matters, you'll find it at FUJIFILM Sonosite. As the creator ... to be confident that they are making the best clinical decisions for any patient, anywhere, anytime. Members of...more than 100 countries. External US Summary:The Senior Program Manager leads the planning, execution, and delivery of multiple… more
- University Hospital New Jersey (Newark, NJ)
- Responsibilities The primary purpose of the Revenue Cycle Training Manager position is to plan, develop, and implement educational programs, training, practice ... standards and quality improvement programs for all University Hospital Revenue Cycle Services'... and workflow redesign strategies. Collaborates and interacts with Clinical , Business, and Information Services personnel to optimize workflows… more
- OU Health (Oklahoma City, OK)
- … improvement activities and supports the Quality and Safety Manager , Medical Directors, and Administrative Director in meeting regulatory and accreditation ... laboratory quality activities including quality monitoring and auditing, occurrence/deviation documentation and performance improvement . Documents deviations in… more
