Medical writer

• Lead the development and execution of medical writing strategies for clinical research projects
• Own medical writing deliverables and apply expertise to complex challenges
• Prepare, review, and edit clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions
• Collaborate with clinical research, biostatistics, regulatory affairs, and medical affairs teams to interpret clinical trial data and summarize scientific findings
• Participate in planning and executing clinical development programs
• Provide strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives
• Develop publication plans, abstracts, posters, and manuscripts for peer-reviewed journals and scientific conferences
• Mentor and coach junior medical writers
• 治験実施計画書の作成
• 治験総括報告書の作成
• 医薬品の承認申請資料（CTD：コモンテクニカルドキュメント）の作成（非臨床または臨床パート）
• 治験薬概要書の作成
• 上記作成ドキュメントのレビュー
• 当局対応（臨床パートのドキュメント作成、レビューまたはコンサルティング等）
• 規制要件を満たす文書作成全般のコンサルティング
• 経験の浅いメンバーへの適切な指導、及びメンバーの成長への貢献

Explore Senior Medical Writer at ICON plc. Review requirements and application details.

Medical writer jobs in Japan

Senior Medical Writer

Medical Writer II, 在宅勤務可