practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines...
Excellent interpersonal, influencing and team building skills Understanding guidelines (FDA, ICH, EMA and GCP) Working...
Administration (FDA), European Medicines Agency (EMA), International Council for Harmonization - Good Clinical Practice (ICH-GCP...
Administration (FDA), European Medicines Agency (EMA), International Council for Harmonization - Good Clinical Practice (ICH-GCP...
, influencing and team building skills Understanding guidelines (FDA, ICH, EMA and GCP) Working knowledge of biostatistics, data...
regulations e.g. ICH/GCP, FDA guidelines, etc. Good computer skills to effectively use automated systems and computerized...
. Collect and submit regulatory/ethics documentation pertaining to the research study. Maintain the FDA 1572 form for assigned...
understanding of ICH-GCP guidelines, FDA regulations, and other applicable global regulatory requirements. Demonstrated leadership...
in spoken and written English Excellent interpersonal, influencing and team building skills Understanding guidelines (FDA...
but not limited to, EU CTR, Health Canada, US FDA IND submissions and/or systems in other regions such as LATAM or APAC. Biotech...