, WHO VigiBase, and EMA EudraVigilance databases. Support exploration of new signal detection methodologies, tools, and data...
and maintain a professional demeanor at all times. Some duties include reviewing medical documentation for accuracy, using EMA EMR...
for veterinary biologics and EMA / EU GMP standards. Automation: Experience with PLC/SCADA systems and data historians (e.g., AVEVA...
strategy and execution Data analytics and business intelligence tools Healthcare regulatory compliance (FDA, EMA...
drafts for patent filings, IND (US-FDA) or CTA (EMA) filings is desirable. Johnson & Johnson is an Equal Opportunity...
to health authority questions related to bioanalytical methods and data. Ensure compliance with FDA, EMA, ICH, and other global...
resources EMA electronic medical records Generous benefits package including healthcare coverage, CME, malpractice insurance...
, and relevant FDA/EMA expectations for drug substance development and manufacture.Experience evaluating or implementing...
. Some duties include reviewing medical documentation for accuracy, using EMA EMR to document all pertinent elements of a patient...
to support cleanability and contamination prevention. Ensure compliance with FDA, EMA, GMP, and company quality-system...-cause investigations, and CAPA development. Knowledge of FDA, EMA, Annex 1, and industry guidance related to cleaning...