【Purpose Statement】
Mission:
・ Develop the CMC part of Briefing Book (BB) for PMDA consultation and Investigator's
Brochure (IB), and execute IP management for the clinical studies conducted in Japan.
・ Develop CTD CMC parts in collaboration with AST and regulatory CMC, and take a lead to
respond PMDA's inquiries for the registration in Japan.
・ Support of group manager in functional activities to carry out the group's mission
【Major Responsibilities】
1. Report to CMC Group Manager in a timely manner.
2. Prepare documents for clinical studies and for registration in Japan, and respond inquiries
from PMDA and clinical sites. And review such documents prepared by other members and
make advices to them.
3. Directly exchange the relevant information with AST, and advise to AST from the Japanese
regulatory and scientific points of view. Manage communications and collaborations
between JAST and AST to make schedules and plans.
4. Coordinate with JAST/AST for supply of IP, make an implementation plan and execute IP
management. Coordinate plans among projects, if necessary.
5. Provide new idea or proposal regarding CMC strategy or enhancing productivities etc., and
support Group manager.
6. Create and execute the career development plan.
7. Attend external trainings and obtain latest information.
8. Educate and motivate group members so as to achieve the group's goal.