メディカルライター/ Medical Writer

A global pharmaceutical company is looking for a Medical Writer. The selected candidate will develop and manage regulatory submission documents while supporting regulatory strategy and cross-functional collaboration in product submissions. This is a remote role.

Responsibilities:

• Author regulatory submission documents including Clinical Summaries, Clinical Overview Addenda, Briefing Documents, and Tables of Studies
• Review and approve regulatory documents in compliance with internal SOPs and regulatory standards
• Manage regulatory writing activities for local product submissions including NDA and BLA filings
• Lead regulatory writing initiatives within local product teams and contribute to regulatory planning
• Coordinate with CRO partners and freelance writers to support submission deliverables
• Develop document timelines and stay updated on regulatory writing practices and technologies

Requirements:

• Bachelor’s degree or above
• 3-12 years of related experience
• Skilled in analysing scientific data and interpret its significance in practical applications, with limited oversight
• Understanding of scientific/technical writing and editing, and of overall clinical
  development process for new compounds
• Proficient in written and spoken Japanese; professional level English (TOEIC 730+)

Preferred requirements:

• More than 5 years of experience in medical writing in the Biotech/Pharmaceutical industry
• Experience with regulatory documents in Regulatory Affairs, Research, Development, or related area
• Knowledge of principles, concepts, theories and standards of
  scientific/technical field
• Understanding of document management systems
• Familiarity with International Council on Harmonisation (ICH) and
  Good Clinical Practice (GCP) guidance and requirements relevant to regulatory submissions

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:

製薬, メディカル, サイエンス, 求人, 外資系, 大阪 求人

Job Ref: 24PBND