エージェント求人

Medical Writer/ ノンラインマネージャー or スタッフ

700~1200万

日本ベーリンガーインゲルハイム株式会社

東京都品川区

募集要項選考・企業概要

職務内容

職種

医薬品メディカルライター

仕事内容

Basic purpose of the job Independently writes and manages clinical documents, such as clinical trial reports, Investigation Brochures, Protocols and briefing documents, in both local and global cross-functional project- and study teams, as well as local clinical regulatory documents for submission to the Japanese Health Authority (HA) and other documents related to HA interaction. Provide critical input to the analysis and interpretation of clinical data in the assigned writing projects.

求める能力・経験

Skills and Competencies: Ability to independently and effectively communicate complex clinical information in writing for the target audiences; scientific and analytical thinking; understanding of medical concepts, statistics, pharmacokinetics, and pharmacodynamics; ability to comprehend and interpret clinical data; understanding of the clinical development process and relevant global and local regulatory guidelines.