- CoxHealth (Lake Spring, MO)
- …to work with others and communicate effectively ▪ Ability to build presentations/present Clinical Documentation Improvement to providers fluently ▪ Ability ... to work with others and communicate effectively ▪ Ability to build presentations/present Clinical Documentation Improvement to providers fluently ▪ Ability… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Clinical Trial Manager will be responsible for the management and oversight of phase I-IV ... clinical trials, with a key focus on Phase 1-2a,...CSR including, but not limited to, development of project documentation , training project staff, monitoring study progress, assessing protocol… more
- Insmed Incorporated (NJ)
- … Clinical Supply Chain to ensure compliance with eTMF documentation and audit readiness activitiesSupport regulatory filings (IND/CTA/IMPD), act as SME ... the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning and… more
- Merck & Co. (Rahway, NJ)
- …program cost estimates requested by Product Development Teams. Responsible for authoring clinical supply documentation in support of labeling and packaging ... approach to identify process inefficiencies, develop solutions, and drive continuous improvement initiatives within the clinical supply planning function. Proven… more
- Stanford Health Care (Palo Alto, CA)
- …or + Certified Outpatient Coder - COC required within 180 Days or + CDIP - Clinical Documentation Improvement Practitioner required within 180 Days or + CCDS ... requires strong clinical acumen, a strong understanding and application of clinical documentation standards, coding, and regulatory requirements, as well as… more
- Merck & Co. (Rahway, NJ)
- …#VETJOBS Required Skills: Adaptability, Adaptability, Change Control Processes, Change Management, Clinical Development, Clinical Documentation , Clinical ... (Bulk Drug Product and Clinical Finished Goods). Responsible for authoring clinical supply documentation in support of labeling and packaging activities as… more
- Genmab (NJ)
- …Then we would love to have you join us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of Study Data ... practices, as well as global agency regulations/guidance's Creates any needed documentation and training for standard processes, change control management and tools… more
- Boost Home Health (Frisco, TX)
- …and enforce Boost HHC policies to ensure regulatory compliance and accurate clinical documentation . Engage in performance improvement initiatives and ... continuous improvement . Lead QA/PI activities to maintain and elevate clinical standards. Manage patient care assignments and oversee staff performance, stepping… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … operations, medical affairs, and regulatory affairs Maintain training assignments on clinical research documentation , regulatory requirements, Good Clinical ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...programs meet regulatory audit requirements and maintain comprehensive training documentation Support preparation for regulatory inspections by ensuring all… more
- Bethesda Health (Kirkwood, MO)
- …and department goals. Is proactive in identifying key strategies for improvement . Empowers staff by promoting accountability, responsibility and authority to enhance ... Prevention Control Committee. Develops action plans to address opportunities for improvement . Participates on the facility's QAA Committee. Implements an annual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of GxP documentation to verify compliance and identify areas for improvement or corrective actions Collaborate with cross-functional teams to ensure that GxP ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...against established metrics Prepare and present regular reports on documentation compliance, audit results, and improvement initiatives… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... operations, process development activities, compliance investigations/change management, authoring of GMP documentation , and lead other staff in the pilot plant as… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- LE Cox Medical Centers (Lake Spring, MO)
- …for following up of patients, educating patients and/or caregivers, and documentation . Dietitians will assist in quality assessment audits, in-service and community ... well as participate in interdisciplinary team for care planning and quality improvement as required by regulatory bodies. May advise patients on health maintenance… more
- Insmed Incorporated (NJ)
- …compliant state throughout their lifecycle a plus .Familiarity with validation of documentation , audit readiness, and continuous improvement of CSV processes. ... compliance with GxP regulations and industry standardsFamiliarity with validation of documentation , audit readiness, and continuous improvement of CSV processes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality Indicators (KQIs). Identify and drive initiatives for continuous quality improvement .Deputize for the Sr. Director, Medical Affairs QA as needed. ... Quality representatives across the organization Quality Management and Continuous Improvement :Lead effective communication efforts within the Medical Affairs team,… more
- Formation Bio (New York, NY)
- …review and approval of batch records, release testing, and other quality-related documentation . Foster a culture of continuous improvement and development within ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the development of manufacturing processes including appropriate documentation .Drive continuous improvement of manufacturing operations leveraging ... operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This ... Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Support manufacturing activities for cGMP compliance through spot… more
