Medical Writer II
Location
Japan
Posted
2 days ago
Salary
0
Seniority
Senior
Job Description
Medical Writer II
Parexel
• 医薬品開発における各種ドキュメントの作成・レビューを担当いただきます。 • 定期安全性報告書(DSUR関連文書)、治験実施計画書(Protocol)、同意説明文書( ICF)、治験総括報告書( CSR)などの作成 • 規制当局提出用文書のための資料作成 • プロジェクトリーダーとしての役割 • ジュニアメディカルライターのトレーニングとサポート
Job Requirements
- 日本の定期安全性報告書(特にDSUR別紙様式及び未知非重篤副作用報告書)作成経験1年以上
- メディカルライティング経験 3 年以上
- ビジネスレベルの英語力
Benefits
- フレキシブルな働き方が可能な環境
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