メディカルライター/ Medical Writer

A multinational pharmaceutical company is seeking a Medical Writer. The selected candidate will author and manage scientific and regulatory submission documents in compliance with global and local regulatory standards while collaborating with cross-functional teams. This is a full remote setup role.

Responsibilities:

• Author scientific and regulatory submission documents, including Clinical Overview Addenda, eCTD Module 2 summaries, and Briefing Documents
• Conduct formal document reviews and approvals in alignment with standard operating procedures
• Manage regulatory writing activities for local product submissions with supervision
• Serve as functional area lead and provide input to local regulatory plans and team objectives
• Collaborate with CROs and freelance writers to ensure timely and high-quality submissions
• Train and mentor junior regulatory writers and contribute to departmental initiatives
• Generate document timelines and ensure adherence to project schedules
• Stay updated with current professional and regulatory developments

Requirements:

• Bachelor’s degree or above in a relevant scientific or technical field
• More than 5 years of experience in medical writing within the Biotech/Pharmaceutical industry
• Proven experience in regulatory document preparation for product submissions
• Skilled in scientific data analysis, technical writing, and editing
• Knowledge of ICH and GCP guidelines and regulatory requirements
• Proficient in MS Office Suite and document management systems
• Native level Japanese; intermediate level English (TOEIC 730+)

About the Company:

A global pharmaceutical group, this organisation is an internationally recognised name in biotechnology. Responsible for a range of medicines aimed at treating human illnesses, this company supplies medical professionals and patients across the world.

Keywords:

メディカルライティング, 規制文書, 製薬業界, 医薬品開発, 科学的データ分析, 文書管理, 規制当局への申請, 求人, 外資系

Job Ref: Z04H9M