Main responsibilities

Document Development

Create high-quality regulatory-compliant clinical documents supporting product life cycle under supervision

Ensure timely delivery while maintaining compliance with company SOPs and guidelines

Innovation

Learn and adopt new digital technologies, AI solutions, and efficient processes

Regulatory Expertise

Prepare clinical documents for registration dossiers and Health Authority responses under structured guidance and close supervision of senior medical writers

Maintain awareness of regulatory documentation requirements

Communication

Work effectively with cross-functional teams

Escalate complex issues to senior team members

Report progress of document preparation to the supervisor

Update relevant stakeholders on project progress and needs

Maintain accurate information in planning, tracking, and reporting tools

Coordination

Support coordination with vendor medical writers under supervision

Quality & Training

Ensure consistent document style and adherence to company standards

Build effective relationships with stakeholders and partners

Knowledge And Skills:

Ability to clearly, accurately, and concisely write/prepare all types of clinical documents in English and Japanese, e.g. scientific authorship experience, editorial experience, etc.

Former experience as a Medical writer or in a position in Clinical Research

A basic understanding of, preferably also experience in basic statistics and experimental research.

Intermediate or higher English skill including writing, reading, listening and speaking.

Respect of guidelines and internal processes

Ability to work effectively in a multicultural, multilingual setting is required.

About you

Core Experience:

Minimum 3 years’ experience in Clinical Development or equivalent, with limited or no prior medical writing experience

Ability to clearly, accurately, and concisely write/prepare clinical documents in English and Japanese

Basic experience in reviewing or contributing to clinical documents

Clinical Development Knowledge:

Basic understanding of clinical development processes

Knowledge of clinical study methodology and basic statistics

Familiarity with regulatory environment and medical terminology

Professional Attributes:

Willingness to learn medical writing principles and practices

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。

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!