BACKGROUND
FOCUS AREAS
Over 20 years of experience in medical writing and clinical development planning
- Medical writing
- Preparation of CSRs, CTDs, clinical study protocols, IBs, and responses to HA questions
Chio Takahisa has more than 15 years of experience in medical writing, covering Clinical Study Reports (CSRs), clinical portion of Common Technical Documents (CTDs), Clinical study protocols, Investigator’s Brochures (IBs), and Responses to the Health Authority (HA) questions. She also has 5 years of experience in various aspects of drug development, with main focus on clinical development planning and HA consultations.
She has extensive experience in medical writing, preparing a number of CSRs, CTDs, clinical study protocols, IBs, and responses to HA questions at 2 global pharmaceutical companies. She also has experience in clinical development planning and has participated in a dozens of HA consultations.
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EDUCATION:
- Bachelor of Technology, at Tokyo Institute of Technology
- Master of Science, at Tokyo Institute of Technology
- Master’s degree in Medical and Pharmaceutical Research, at Brussels Free University
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PROFESSIONAL EXPERIENCE:
- Senior Manager, Product Development, Clinical, at Eliquent Japan (3 years)
- Medical Writer / Lead Medical Writer / Group Manger, at Nippon Boehringer Ingelheim (9 years)
- Senior Manager, Product Development Planning, at IDEC Inc. (3 years)
- Medical Writer / Senior Medical Writer / Project Manager, at Novo Nordisk Pharma (7 years)
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