募集要項

仕事内容: CSLベーリング株式会社での募集です。
臨床開発メディカルライターのご経験のある方は歓迎です。
The Senior Medical Writer is responsible for planning preparing and managing medical writing projects as well as creating and reviewing documents in some instances.

Reporting to the Head of Clinical Development Japan the Senior Medical Writer is responsible for the creation and maintenance of document/presentation templates and the assembly and quality control review of medical writing projects related to clinical development as well as regulatory submissions.

■Key Roles Responsibilities
Responsible for planning and preparing high quality medical writing deliverables that support the clinical development and regulatory requirements for Japan:

・Develops medical writing project timelines in collaboration with relevant functions and global counterparts
・Responsible for ensuring the appropriate plan process and tools are in place for content editing formatting quality checking and publishing
・Creates and reviews documents according to the plan<…

応募資格

必須: ■Qualifications Skills Experience
・An undergraduate degree in pharmacy biological sciences or related disciplines is essential post graduate qualifications desired
・Prior experience of working in the role of medical writer within the CRO/Pharma/Biotech industry
・A minimum of 5 years Clinical experience in the role of medical writer
・At least one experience as a lead writer for J CTD
・Experience in developing clinical study reports in English is preferable
・A solid understanding of the Clinical Development Process including the documents that are required at each stage of development
・Excellent writing and oral communication skills （clear and logical） in both English and Japanese
・Strong interpersonal skills and time management skills
・Expert MS Office ski…

フィットする人物像: JAC Recruitmentでは、担当コンサルタントが直接企業へ訪問。だからお伝えできることがあります。
面談の際に、採用担当者からお聞きした情報やコンサルタント自身が感じた選考のポイントを皆さまへお届けします。

休日休暇: 【有給休暇】初年度 16日 1か月目から（入社月によって異なります）
【休日】完全週休二日制
土
日
祝日
夏季休暇
年末年始
年間休日は年度により異なる：126 日（2025年）、128日（2026年）
その他会社の定める休日（5/1）、有給休暇使用推奨日など

会社概要