メディカルライター(FSO Medical Writer/ IQVIA Services)
On-siteOsaka, Osaka, Japan
Osaka, Osaka, JapanOn-siteFull TimeSenior LevelSmall
Full TimeSenior LevelSmall
Job Summary
Create clinical trial documents including protocols, summary reports, and common technical documents, ensuring Japanese regulatory compliance for global trials. Develop post-marketing surveillance materials such as periodic safety reports and reapplication dossiers. Author clinical study reports and manuscripts, while performing quality control on various documents. This role supports diverse therapeutic areas within IQVIA's Medical Writing department, leveraging expert guidance from internal medical and regulatory specialists. Work remotely from Osaka with a hybrid schedule.
Required Qualifications
- 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
Desired Qualifications
- 臨床薬理の知識、経験がある方
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.