Manager, Medical Writing

Contribution as a medical writer in his 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 Biogen's programs

?Key Responsibility? ?Preparation of CTD in M1, M2 (clinical parts) and M5 ?Preparation of response documents to PMDA questions during approval review ?Preparation of briefing document (BD) for PMDA Consultation regardless informal and formal ?Preparation of response documents to PMDA questions during PMDA consultation ?Preparation of relevant attachments to CTN such as IB, protocol, informed concent and others ?Preparation of response documents to PMDA questions during clinical application (CTN) ?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

?Solid experience in medical writing with scientific information in his field ?Communication skill in Englis

Manager, Medical Writing