シニアメディカルライター – IQVIA Services
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Job Description
Senior Medical Writer creating and reviewing clinical trial documents at IQVIA. Involves managing projects and guiding junior staff in the medical writing team.
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)の作成およびレビュー業務
- 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およびレビュー業務
- 臨床研究・PMS関連文書(実施計画書、安全性定期報告書、論文など)の作成およびレビュー業務
- プロジェクトの進捗管理、人員管理、予実管理、顧客対応
- 後輩スタッフの指導、他
Requirements:
- Medical Writing経験5年以上(翻訳のみは不可)
- 理系大学、大学院卒
- 医薬品開発全般、GCP、ICH関連ガイドラインを理解している
- 国内の薬事規制に関する知識を有する
- 薬学・医学・統計学の基礎知識を有する
- 英語スキル:読み書きができる(英文書Review・添削ができる、英文和訳ができる、英文レポート作成ができる)、目安:TOEIC 730以上、会話は日常会話程度
- Fluency in Japanese would be required
- 臨床薬理の業務経験があればなお可(自身で解析していなくても可)
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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