Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
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...
. Ensure documents comply with company procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices...
Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
preferred Experience utilizing Modernizing Medicine / EMA Electronic Medical Record (EMR) highly preferred. Compensation...
, and aseptic small molecule production to ensure compliance with FDA, EMA, and other regulatory bodies. Review and approve... resolution. Host and facilitate audits from regulatory authorities (e.g., FDA, EMA) and clients, preparing documentation...
Compliance Ensure all CQV activities are executed in compliance with cGMP, FDA, EMA, ICH, and other applicable regulatory... of current Good Manufacturing Practices (cGMP), regulatory guidelines (FDA, EMA, ICH), and industry standards. Experience...
. Use EMR systems efficiently (EMA experience is a plus). Deliver outstanding care for patients of all ages. What We’re...
, HTA Coordination Group JCA Dossier guidance, and EMA's Reflection paper on patient experience data). Proficiency in R...