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Nathalie Ross, Ph.D. RAC, has been a freelance writer since 1997. She offers bilingual services in medical, regulatory, and scientific writing. • EXPERIENCE AND EXPERTISE • Managed a large number of clinical trial applications and new drug submissions for Health Canada and the Food and Drug Administration, mainly in the therapeutic areas of gastroenterology and oncology / Prepared applications for new medical device licences and investigational device exemptions for orthopaedic, cardiovascular, dental, and plastic surgery medical devices / Communications include over 100 scientific articles, conference proceedings, posters and presentations, radio interviews, trade and consumer magazines articles, and technical publications. • SERVICES • Medical and Regulatory Writing: investigator’s brochures, product monographs, clinical trial applications, new drug submissions, new substances notifications, requests for orphan drug designation / Scientific Writing: grant proposals, literature search, research papers, book chapters, course notes. EDUCATION AND CONTINUING EDUCATION: - B.Sc.A., Food Sciences, Université Laval (Quebec, Canada) - M.Sc.A., Food Sciences, Université Laval (Quebec, Canada) - Ph.D., Civil Engineering (Environmental Biotechnology), École Polytechnique de Montréal (Montreal, Canada) - Certificate, Pharmaceutical Regulatory Affairs and Quality Operations, Seneca College (Toronto, Canada) - Regulatory Affairs Certified (RAC), Regulatory Affairs Professionals…