Purpose

・Prepare high-quality and accurate NDA-related documents (CSR, CTD, etc.) in accordance with regulatory requirements based on policies of global R&D and Japan Development.

・Cooperate with the lead-writer for the formulation of strategies such as policy, schedule, budget, etc. for preparation of NDA-related documents as a sub-writer of the project in charge.

Major Responsibilities:

• Prepare NDA-related documents and arrange their quality control as a sub-writer.
• Make every effort to prepare high-quality NDA-related documents in accordance with pharmaceutical regulations, SOPs, manuals, etc.
• Participate in the decision making of the assigned JDT with the lead-writer.
• Cooperate with lead-writer in the formulation of strategies such as policy, schedule, budget, etc. for preparation of NDA-related documents of the project in charge.
• Prepare appropriate procedures for development and maintenance of NDA-related documents.
• Build cooperative relationships with stakeholders in Global MW.
• Prepare/update appropriate procedures for the vendor management.
• Conduct liaison activities with the vendor regarding preparation of NDA-related documents.