through development, database lock, and reporting/submission. Deep understanding of ICH-GCP, FDA, EMA, and other global...
for accuracy, using EMA EMR to document all pertinent elements of a patient exam accurately and thoroughly, and other duties...
Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
integrity in all endeavors. Direct involvement in assisting with the preparation of regulatory submissions to the FDA or EMA...
Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
. Ensure documents comply with company procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices...
of testing services, adherence to regulatory standards (FDA, EMA, ICH), and effective communication with internal teams...
. Ensure documents comply with Company’s procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices...
preferred Experience utilizing Modernizing Medicine / EMA Electronic Medical Record (EMR) highly preferred. Compensation...