※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
Contribution as a medical writer in his/her expertise mainly clinical parts for all regulatory documents (CTD, briefing document for consultation, etc.) and positive involvement in strategic regulatory discussion during entire drug development process and also J-NDA from submission to approval for company's programs
- Preparation of CTD in module 2 (clinical parts) and module 5 as well as parts of module 1
- Preparation of briefing document (BD) for PMDA Consultation regardless informal and formal
- Preparation of response documents to PMDA questions during approval review, PMDA consultation, etc.
- Communication with global teams to get necessary information and supports
- Vendor management necessary for all document preparation including translation and edition
- Intermediate experience (around 5 years) of medical writer in global drug development including submission/approval and launch of new products
- Life Science bachelor degree
- Solid experience in medical writing with scientific information in his field
- Knowledge of regulatory filing strategy in Japan
- A talent of writing sense in English and Japanese
- Computer literate
- Skill of time management
- Skill of vendor management
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.