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- Management and Leadership: Over 15 years of project management experiences across early-stage, large-scale and Post-Marketing studies, and managed and mentored a dozen to two dozen staff including Clinical Leaders and CRAs, as well as cross-functional department managers
- Pharmacovigilance and Regulatory Oversight: Experiences in Post-Marketing Surveillance, and local pharmacovigilance support to global Medical Directors in clinical trials, with practical knowledge regarding local regulatory requirement, Japan Pharmaceutical and Medical Device Act (PMD Act) and GxPs, e.g. GCP, GVP, GPSP adopted throughout clinical development and product life-cycles
- Japanese Medical Documentation: Quality-assured regulatory and clinical documentations written in Japanese, including English translation, which fully reflects the understanding and interpretation for medical and scientific terminology in both languages
- Financial Management: Keep projects in line with budget and profit expectations, with proven records on the concrete achievement of expected profitability for all involved projects.