Medical Writer

1. About the job

Our Team:

Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing.

Main responsibilities:

Document Development

• Create high-quality regulatory-compliant clinical documents supporting product life cycle
• Ensure timely delivery while maintaining compliance with company SOPs and guidelines

Innovation

• Support implementation of new digital technologies and AI solutions
• Participate in process improvements for efficiency gains

Regulatory Expertise

• Prepare clinical documents for registration dossiers and Health Authority responses under guidance
• Maintain awareness of regulatory documentation requirements

Communication

• Work effectively with cross-functional teams
• Update relevant stakeholders on project progress and needs
• Maintain accurate information in planning, tracking, and reporting tools

Coordination

• Oversee writing activities from vendors
• Review vendor deliverables

Quality & Training

• Ensure consistent document style and adherence to company standards
• Build effective relationships with stakeholders and partners

2. About you

Core Experience:

• Minimum 5 years’ experience in Clinical Development or equivalent, with minimum 1‑2 years as medical writer
• Ability to clearly, accurately, and concisely write/prepare clinical documents in English and Japanese
• Experience in preparing clinical documents and regulatory submissions

Clinical Development Knowledge:

• Basic understanding of clinical development processes
• Knowledge of clinical study methodology and basic statistics
• Familiarity with regulatory environment and medical terminology
• Proficient in document management systems and authoring platforms

Professional Attributes:

• Strong attention to detail and deadline management
• Strong organizational and follow-up abilities
• Ability to work independently and in global teams

Technical skills:

• Proficiency in electronic document management and Microsoft Office
• Interest in implementing emerging innovative digital technologies, including AI-assisted document authoring solutions.

Education:

• Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified.

Languages:

• Intermediate or higher level in written and spoken English. Native Japanese.

Selling Point:

私たちはメディカルライティングのプロフェッショナルとして、医薬品の承認申請資料を中心に、科学的正確性や規制要件を満たしたさまざまな臨床文書の作成を通して患者さんに新薬をいち早く届けるため、日々真剣に業務に取り組んでいます。

グローバル組織の一員として、国内のみならず世界中のさまざまなバックグラウンドや専門性を持つメンバーと協働することにより、グローバルな医薬品開発に貢献しています。

AIツールの活用をグローバル全体で推進し、メディカルライティングの効率と品質の向上とともに、個人のスキルアップも積極的に支援しています。