• Coordination/writing of regulatory documents according to ICH standards and Sanofi R&D SOPs:
•
o Clinical study reports (CSR)
o Investigator Brochure
o Investigational Medicinal Product Dossier (IMPD)
o Development Safety Update Report (DSUR)
o Narratives
o Orphan drug annual report
• Active collaboration with regulatory, pharmacovigilance, biostatistics and clinical departments in an international environment
• Liaising with publishing and quality control teams
• Timelines management
Medical writer at RPS Research France CRO (formerly THERAPHARM Recherches), Boulogne-Billancourt, Fr
- Rédacteur médical / Medical writer
2005 - 2011Medical writing activities (working within the CRO on client’s projects):
• Coordination/writing of clinical / regulatory documents according to ICH standards and RPS or customer’s SOPs:
o clinical study protocols and clinical study reports
o informed consent forms
o protocol amendments
o case report forms
o narratives
• Review of statistical analysis plan
• External contractor management for writing of publications
• Resources and timelines management
• Responding to queries from regulatory authorities
• Active collaboration with business development, project management, regulatory, pharmacovigilance, biostatistics and clinical departments in an international environment
Main therapeutic area: oncology, gastroenterology, metabolism, nutrition, allergy, and rheumatology
Formations
Faculté De Pharmacie - Université Paris-Sud XI (Chatenay Malabry)
Chatenay Malabry2000 - 2001Post-graduate degree in Pharmacokinetics and Drug Metabolism
