Job Level
Lead
About the role
- Create/revise medical related high quality documents such as CTD and CSR in accordance with regulatory guidance
- Verify documents meet high quality standards and match original source documents
- Establish and maintain relationships with relevant departments in Pfizer Japan and Global for JMT/JVT activities
- Collaborate with Global Medical Writing Group and contribute to Global NDA and JNDA submissions
- Respond to PMDA queries by creating high-standard documents to reduce review time
- Draft disclosure documents and prepare redacted CTD; create parts of PMS documents
- Handle publications and maximize use of outsourcing while sharing knowledge with partners
- Attend MW industry activities to influence MW-related guidelines and support line manager to ensure smooth MW operations
Requirements
- Create/revise medical related high quality documents such as common technical document (CTD) and clinical study report (CSR) in accordance with various regulatory guidance and SOPs
- Verify documents meet high quality standard (contents match original source documents and texts are logically described) and confirm no errors
- Collaborate with Global Medical Writing Group and relevant departments in Pfizer (Global and Pfizer Japan)
- Contribute to Global NDA submissions and JNDA submissions; support PMDA queries
- Create parts of PMS documents, draft disclosure documents and prepare redacted CTD
- Handle publications and manage outsourcing partners; share knowledge and skills with outsourcing
- Improve medical writing skills through discussion, review comments, and supporting line manager
- Participate in MW industry activities and contribute to MW-related guideline drafting
- Strong communication and cross-functional collaboration skills; ability to work on global simultaneous development projects