Lead and support the development of regulatory documents, including CTD modules and briefing documents, for Biogen programs from early development to J-NDA submission
Job Summary
Lead and support the development of regulatory documents, including CTD modules and briefing documents, for Biogen programs from early development to J-NDA submission.
Collaborate closely with global teams, manage external vendors, and contribute to Japan regulatory strategy.
Biogen fosters an environment where individual contributions make a significant impact, offering unparalleled opportunities for learning, growth, and skill expansion.
Matching Summary
Lead and support the development of regulatory documents, including CTD modules and briefing documents, for Biogen programs from early development to J-NDA submission.
Skills & Requirements
Must-have
Clinical and regulatory document preparation
CTD modules and briefing documents
PMDA consultation support
English and Japanese writing proficiency
MS Word, Adobe Acrobat, Documentum
Vendor management experience
Nice-to-have
Proactive workstyle with emerging technologies
Global team collaboration
Pioneering spirit and commitment to excellence
Inclusion and belonging culture
Key Requirements
Approximately 5 years clinical medical writing experience
Approximately 3 years nonclinical writing experience preferred