submission Knowledge of international regulations (ICH, FDA, EMA) Preferred: Advanced and broad knowledge of Statistical...
but not limited to GMP, FDA, EMA, and ICH guidelines. Collaborate with MSAT, Project Management, Engineering, and other departments...
in a pharmaceutical environment In depth working knowledge and conversant with cGMP guidelines and Health Authority regulations (EMA...
. The position will be primarily focused on research recruitment, acquiring behavioral, app-based, EMA and neuroimaging data...
and EMA regulated environment. Demonstrated proficiency in interpretation of FDA and EMA cGMP regulations...
experience with deep expertise in U.S. FDA, EMA, and international regulations within scientific and commercial contexts...
., ICH or VICH, FDA, EMA, etc.), with direct experience preparing submissions and engaging with health authorities. Highly...
practice required Experience with ModMed (EMA) or similar EMR preferred Must have excellent time management skills...
Ability to post copays into EMA Ability to verify straight Medicare vs Medicare Advantage Plan Distinguish primary insurance... Proficiency in Microsoft Office and EMA software Effective verbal and written communication skillsAbility to maintain...
Well-supported environment with trained medical assistants, front office staff and EMA / EMR Compensation & Benefits...