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 cycleEnsure timely delivery while maintaining compliance with company SOPs and guidelines

Innovation

Support implementation of new digital technologies and AI solutionsParticipate in process improvements for efficiency gains

Regulatory Expertise

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

Communication

Work effectively with cross-functional teamsUpdate relevant stakeholders on project progress and needsMaintain accurate information in planning, tracking, and reporting tools

Coordination

Oversee writing activities from vendorsReview vendor deliverables

Quality & Training

Ensure consistent document style and adherence to company standardsBuild 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 writerAbility to clearly, accurately, and concisely write/prepare clinical documents in English and JapaneseExperience in preparing clinical documents and regulatory submissions

Clinical Development Knowledge:

Basic understanding of clinical development processesKnowledge of clinical study methodology and basic statisticsFamiliarity with regulatory environment and medical terminologyProficient in document management systems and authoring platforms

Professional Attributes:

Strong attention to detail and deadline managementStrong organizational and follow-up abilitiesAbility to work independently and in global teams

Technical skills:

Proficiency in electronic document management and Microsoft OfficeInterest 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。

Pursue progress, discover extraordinary

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!