About Séverine
French
Native or bilingual
English
Fluent
Experience
- INSTITUTdesMICIRédactrice médicaleNovember 2024 - November 2024 (1 month)-Review and writing of all SOPS for clinical department (regulatory, quality)-Creation of new SOPs
- CRO Excelya-Medicalwriter coordinatorJuly 2021 - September 2024 (3 years and 2 months)-Narratives vendor coordinator/Medical writer coordinator for SANOFI-International trials ∗ Project management with CROs international ∗ Vendors oversight (budget, meeting): TCS, Cognizant ∗ Medical writer coordinator: narrative template, narrative writing quality check, study's timelines ∗ Review of narratives document: vendor's quality check of writing versus source documents∗ Review of SOP for medical writing
- CRO Excelya-ClinicalProject ManagerJuly 2018 - July 2021 (3 years)-Global study manager for SANOFI-International trial in Rare Disease-Pediatric Multiple Sclerosis ∗ Project management with CROs international ∗ Vendors oversight: Covance, Neurostatus, Esms, PPD ∗ Data management oversight (eCRF cleaning, Data Base Lock oversight) ∗ Patients profiles-Medical Review
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Education
- Clinical Research Project Manager trainingFORMATIS2016Clinical Research Project Manager training
- DU ExperimentationUNIVERSITY2009DU Experimentation
Skill set
Categories
- Other