Description
We are seeking a Lead Medical Writer to join our Medical Writing department. As a Lead Medical Writer, you will be responsible for creating and reviewing various documents related to clinical trials, including study protocols, reports, and regulatory submissions. You will also manage projects, personnel, and budgets, and provide guidance to junior staff members.
Responsibilities:
- Create and review clinical trial-related documents, such as study protocols, reports, and regulatory submissions
- Manage projects, personnel, and budgets
- Provide guidance to junior staff members
- Collaborate with cross-functional teams, including physicians and regulatory experts
Requirements:
- 5+ years of medical writing experience (not just translation)
- Life science or related field degree
- Understanding of pharmaceutical development, GCP, and ICH guidelines
- Knowledge of domestic pharmaceutical regulations
- Basic knowledge of pharmacology, medicine, and statistics
- English skills: reading, writing, and conversation (TOEIC 730+)
- Fluency in Japanese
Nice to have:
- Non-clinical (pharmacology, toxicology, ADME) knowledge and experience
- Clinical pharmacology knowledge and experience
What we offer:
- Competitive salary
- Comprehensive benefits package
- Flexible working hours
- Remote work options
- Opportunities for professional growth and development