Experience with ctd modules and briefing documents
This role leads the preparation of regulatory documents including CTD modules and briefing documents for PMDA consultations
Job Summary
This role leads the preparation of regulatory documents including CTD modules and briefing documents for PMDA consultations.
The position requires strong leadership skills to plan, coordinate, and drive document development while managing external vendors.
Biogen fosters an environment where individual contributions make a significant impact within a global team committed to delivering life-changing medicines.
Matching Summary
This role leads the preparation of regulatory documents including CTD modules and briefing documents for PMDA consultations.
Skills & Requirements
Must-have
Strong experience in clinical medical writing
Proficiency in English and Japanese languages
Experience with CTD modules and briefing documents
Leadership skills for document development teams
Vendor management for translation and editorial services
Nice-to-have
Proactive workstyle incorporating generative AI
Broad understanding of Japan regulatory strategy
Experience with Documentum-based systems
Ability to build diverse effective teams
Key Requirements
Life Science degree required
Approximately 5 years of clinical medical writing experience
Approximately 3 years of nonclinical writing experience preferred