of applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, etc.) and global eCTD...
. Thorough working knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA...
with state-of-the-art equipment 2-3 experienced medical assistants assigned per provider EMA software for efficient...
: Practice in a state-of-the-art clinic equipped with the latest tools and technology, including EMA software for streamlined...
but not limited to, FDA, EMA, ICH, USP, EP, JP, and CHP Extensive knowledge of analytical method validations and method transfers...
by experienced medical assistants Practice utilizes EMA / EMR software Visibility factor-participate in professionally produced...
-40 patients per day with experienced clinical and administrative support Fully equipped, modern clinic utilizing EMA...
, robust support staff and efficient EMA software make this an ideal environment for a motivated Nurse Practitioner...
, EMA, Health Canada, PMDA, and other global authorities). Manage submission lifecycle activities, including sequence... and validation software. Strong understanding of global regulatory requirements and electronic submission standards (FDA, EMA...
Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management...