(ADaM) and summaries (TFLs) in support of clinical study reports and regulatory submissions (FDA, EMA, etc.). Responsible...
development phase, including but not limited to: understanding IND submission requirements of the U.S., China, and EMA;evaluating...
standards like FDA, EMA, and EU Annex 1. Leading innovation efforts by evaluating and introducing new clean utility...
, including having played a lead role in more than one IND/IMPD, BLA/NDA/MAA filing and in Advisory Committee or other PMDA/EMA... major regulatory filings – IND/IMPD, BLA/NDA/MAA. Experience leading preparation of PMDA/EMA/FDA milestone meetings...
technical experience with FDA, EMA, PMDA, CFDA, and global regulations as they relate to analytical methods, control strategies...
, including having played a lead role in more than one IND/IMPD, BLA/NDA/MAA filing and in Advisory Committee or other PMDA/EMA... major regulatory filings - IND/IMPD, BLA/NDA/MAA. Experience leading preparation of PMDA/EMA/FDA milestone meetings...
. Why You'll Love This Position: Work 4-4.5 days per week in a high-volume practice setting with modern equipment and EMA software...
smooth. Cutting-Edge Clinic: Work in a fully equipped, state-of-the-art facility using EMA software for seamless patient...
(preferred) Familiarity with the ModMed EMA EMR (preferred) Thorough understanding of HIPAA law Team player Physical...
team and experienced support staff Average patient volume of 32+ per day with 3-4 fully equipped exam rooms EMA / EMR...