Modernizing Medicine / EMA Electronic Medical Record (EMR) highly preferred. Compensation The position will offer competitive...
of previous experience in dermatology medical office preferred Experience utilizing Modernizing Medicine / EMA Electronic Medical...
with regulatory requirements (FDA, EMA, PIC/S, Annex 1) and sterility assurance initiatives, microbiological oversight collaboration...
, EMA, MHRA, or other regulated industry inspections and compliance programs. Experience supporting regulatory...
, such as ad hoc data mining of FDA FAERS, WHO VigiBase, and EMA EudraVigilance databases. Support exploration of new signal...
Skills/Experience: Experience with FDA advisory committee and/or EMA oral explanation. - Experience working on due...
approval or major submission activity. Experience with FDA advisory committee or EMA oral explanation preparation...
handling. Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data...
including electronic data submissions, especially with FDA, PMDA, EMA, and other global agencies. Experience with integrated...
handling. Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data...