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Medical Writing Manager

年収:800万 ~ 1000万

ヘッドハンター案件

部署・役職名 Medical Writing Manager
職種
業種
勤務地
仕事内容 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 our programs

・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
応募資格

【必須(MUST)】

Life science degree

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/her field
・Communication skill in English
・Knowledge of regulatory filing strategy in Japan
・A talent of writing sense in English and Japanese
・Skill of time management
・Skill of vendor management

更新日 2019/02/14
求人番号 902095

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