Description
PROFESSIONAL SUMMARY * BS in Pharmacy, PhD in Pharmacology, Habilitation in Experimental Medicine. * Over 10 years regulatory writing experience, developing high quality, consistent and harmonized documents under tight timelines focusing on content, presentation, and structure of the documents following legal and regulatory requirements, SOPs and company policies. * Clinical Study Reports, all phases including exploratory clinical pharmacology studies * Investigator Brochures * Narratives