Medical Writer II

This is a fully remote position, open to applicants in Japan.

📋 Description

• You will be responsible for the creation and review of various documents related to pharmaceutical development.

• Preparation of periodic safety reports (documents related to DSUR), clinical trial protocols, informed consent forms (ICF), and clinical study reports (CSR), among others.

• Development of materials for documents intended for regulatory authority submissions.

• Role as a project leader.

• Training and support for junior medical writers.

⛳️ Requirements

• Over one year of experience in creating periodic safety reports in Japan, particularly DSUR appendices and reports on unknown non-serious adverse effects.

• At least three years of experience in medical writing.

• Proficiency in English at a business level.

🏝️ Benefits

• A flexible work environment that accommodates various working styles.