Medical Writer II

🔥 0 minutes ago

🗣️🇯🇵 Japanese Required

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Logo of Parexel

Parexel

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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

🎯 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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