- ZOLL Medical Corporation (Irvine, CA)
- …sleep disorders. Our core product is the WatchPAT(R)️ family, a revolutionary FDA -cleared portable home sleep apnea test device, that is based on proprietary ... utilization and revenue.Essential Functions + Work in collaboration with your Region Sales Manager , Cardio Key Account Manager and VA/Gov't Account Manager … more
- Gilead Sciences, Inc. (Foster City, CA)
- …ensure utility systems operate within validated parameters and comply with cGMP, FDA regulations, and company safety & quality standards. + Ensure system ownership ... + Provide technical support and training for operations and maintenance personnel. ** Project Management & Collaboration** + Manage small to medium projects related… more
- Mentor Technical Group (Millbrae, CA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... expectations, and anticipating possible barriers or obstacles that may impact the project (s) adversely and communicating these on a timely manner. + Guarantee top… more
- BeOne Medicines (Emeryville, CA)
- …Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project /study documents and answer ad-hoc safety queries from ethics committees. + Lead ... (eg, clinical development, medical, regulatory, labeling) and external stakeholders (eg FDA , MHRA, EMA, other regulatory agencies). + Contribute to continuous… more
- Charles River Laboratories (Thousand Oaks, CA)
- …data patterns. + Record, prepare, and analyze data for inclusion in project reports. + With guidance from scientific management, maintain a technical knowledge ... o Necropsy, tissue and fluid collections + Assist Operations Manager and provide coverage for monitor animal health and...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Parexel (Sacramento, CA)
- …(SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for ... (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study...of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Must be fluent… more
- Cardinal Health (Sacramento, CA)
- …(General Data Protection Regulation), CCPA (California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV (Computer System Validation), DSCSA(Drug ... and implement control framework across it + Hands-on experience with GRC platforms, project management tools, and service management systems, with a focus on scaling… more