Purpose Statement:

• Prepare high-quality and accurate Japan-specific regulatory and clinical documents in accordance with regulatory requirements based on policies of Global R&D including Global SMW, and Japan Development.
• Provide project management for all projects for assigned team.
• Serve as local coordinator to streamline the communication between Japan project team and all global stakeholders including global medical writing team (Strategic Medical Writing [SMW]).
• Liaison activities with medical writing vendor in Japan as needed regarding preparation of regulatory and clinical documents.

Major Responsibilities:

• Provide effective leadership of assigned work to support smooth progress of each project in accordance with pharmaceutical regulations, SOPs, manuals, etc.   Primary remit includes but is not limited to:
• Briefing books including those for PMDA consultation/pre-meeting
• Request form for PMDA consultation/premeeting
• Responses to PMDA/MHLW for (s)NDA, PMDA consultation, and CTN, including being part of the Rapid Response Team (RRT)/Labeling Subteam (LST) Responses to Agency Questions including ad hoc requests including those for PMDA consultation/premeeting documentation
• J-CTD Module 1 to include Japan package insert
• Japan s(NDA) application form
• Orphan Drug Designation request form, briefing book, application form
• Sakigake Designation request form, briefing book, application form
• Specific Use designation request form, briefing book, application form
• Japan Package Insert Maintenance, including update of side effect sections, assessment description based on CCDS revision
• Japan CTD updates during (s)NDA
• Post-submission safety updates
• Advise on the document structure and content based on medical writing industry best practices and experience in medical writing.
• Formulate assignment plan and timeline for responsible cross-functional team members to each project, collecting the inputs from Japan project team and managing the project to completion.
• Build cooperative relationships with all cross-functional stakeholders both local and global (Global R&D, Development TA, Data & Statistical Sciences, Global Regulatory Strategy, Global SMW, Clinical Sciences, Japan Project Team, TAG, JDSSG, vendors)

• etc.) and effectively represent SMW at assigned meetings, as necessary.
• Prepare/update appropriate procedures when using a medical writing vendor.
• Ensure that appropriate quality control (QC) checks are performed on medical writing deliverables, as required. Ensure authoring and review with the electronic document management system.