Medical Writer

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募集要項

会社概要

同社はアメリカを拠点とする親会社を持つ大手ライフサイエンス企業です。主に医薬品やワクチンの研究開発、輸入、製造、販売を事業として展開しています。人々の健康を守り、豊かな人生を築く手助けをすることで、同社の使命・目標に向かって日々奮闘し、日本の満たされていない医療ニーズにいち早く応えてゆきます。さらに、さまざまなプログラムやパートナーシップを通じ医薬品を必要とする人々への製品寄付や供給を行い、医薬品へのアクセスを推進する活動に積極的に取り組んでいます。

業務内容

• Preparation of investigational drug summary (IB)
• Preparation of a general report (CSR)
• Creation of Approval Application Material (CTD) Clinical Part
• Preparation of draft package insert (clinical part) for development products
• Preparation of face-to-face advice (pre-application consultation) materials
• Creating answers to inquiries regarding clinical parts after application for approval
• Publication of clinical trial results on the clinical trial information registration site

応募条件

Have one of the following experiences:

• Experience in creating CTD clinical part (module 2.5, 2.7.3, 2.7.4, 2.7.6) or clinical pharmacology part (module 2.5, 2.7.2, 2.7.6)

 

• Experience in creating clinical trial implementation plans, clinical trial summary reports, and face-to-face advisory materials
• CRA experience
• Ability to analyze and interpret scientific thinking and clinical trial data
• English ability (TOEIC 730 points or more, you can negotiate without problems at meetings and emails with overseas headquarters)
• Communication skills (have interpersonal coordination and can build good relationships with stakeholders)
• Project management ability (can make execution plans for multiple tasks and control tasks and risks so that the objectives can be achieved with appropriate deadlines and qualities)

給与

800 - 1200 万円

勤務地

東京