メディカルライター, FSO Medical Writer
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Job Description
Medical Writer creating clinical trial documents and quality control for pharmaceutical firms in Japan. Collaborating with teams to meet Japanese requirements for global studies.
Responsibilities:
- 臨床試験関連文書(治験実施計画書、治験総括報告書、コモンテクニカルドキュメント等)の作成
- グローバル試験の治験実施計画書に対して日本要件を満たすための修正版の作成
- 製造販売後調査関連文書(安全性定期報告、再審査申請資料等)の作成
- 臨床研究報告書・論文の作成
- 各種文書のQC
Requirements:
- Medical Writing実務経験がある(翻訳のみの方は対象外)
- 理系大学、大学院卒
- 薬学・医学的な基礎知識を有する
- 医薬品開発全般、GCP、ICH関連ガイドライン、国内薬事規制(GPSP等)を理解している
- 英語の読み書きが可能(辞書を使って英文書の添削や和文英訳が可能なレベル)
- Fluency in Japanese would be required
- 臨床薬理の知識、経験がある方歓迎
Benefits:
- 法定内(社会保険制度)・法定外(IQVIA独自制度)の両面から充実した福利厚生制度あり
- 受動喫煙対策:あり
- 年次有給休暇、夏季休暇、病気休暇、特別休暇、女性特別休暇、育児介護休暇、看護休暇·など
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