Naoto Kotani

• Project Coordination: Managed support services for pharmaceutical development projects using a specialized expert platform
• Conducted comprehensive client meetings to assess requirements and identify the appropriate subject-matter experts. Conducted approximately two new client meetings per week to discuss potential projects.
• Negotiated contract terms, including Statements of Work (SOW), costs, and timelines, by acting as an intermediary between clients and experts.
• Business Development: Contributed significantly to team revenue goals
• In the first year, my work on key large-scale projects helped the team achieve its sales targets
• In the second year, I consistently exceeded individual client meeting targets, reinforcing outstanding team performance
• Key Projects:

　- Supported investigator-initiated clinical trials in oncology

　- Managed non-clinical trial projects for university startups

　- Developed comprehensive regulatory requirement reports for quasi-drug development

　- Coordinated clinical development support for medical devices and regenerative medicine products

• Operational Excellence: Demonstrated strong project management with minimal disruptions and achieved the highest rate of repeat business within the team

• Dual Role: Simultaneously served as a Reviewer and a Clinical Trial Consultant, ensuring comprehensive evaluation from both regulatory review and consultation perspectives
• Reviewer Responsibilities: Reviewed application materials for anti-cancer drugs with a focus on biostatistical evaluation
• Collaborated with clinical and cross-departmental teams to formulate inquiry items and responses
• Drafted detailed review reports, contributing to the annual evaluation of approximately 20–30 new drug submissions
• Clinical Trial Consultation Responsibilities: Analyzed consultation materials for anti-cancer drug development, extracting key insights on trial design and statistical planning, handling approximately 40–50 cases annually
• Articulated agency opinions and participated in face-to-face consultations
• Delivered training sessions on clinical trial design and biostatistical methods