Manager, Medical Writing
- Full-time
- Region: APAC
- Department: Research & Development
Job Description
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
?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
Qualifications
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
?Solid experience in medical writing with scientific information in his field
?Communication skill in Englis
Additional Information
Manager, Medical Writing
By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply