Medical Writer

About the jobOur TeamGlobal 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 ResponsibilitiesDocument DevelopmentCreate high-quality regulatory-compliant clinical documents supporting product life cycleEnsure timely delivery while maintaining compliance with company SOPs and guidelinesInnovationSupport implementation of new digital technologies and AI solutionsParticipate in process improvements for efficiency gainsRegulatory ExpertisePrepare clinical documents for registration dossiers and Health Authority responses under guidanceMaintain awareness of regulatory documentation requirementsCommunicationWork effectively with cross-functional teamsUpdate relevant stakeholders on project progress and needsMaintain accurate information in planning, tracking, and reporting toolsCoordinationOversee writing activities from vendorsReview vendor deliverablesQuality & TrainingEnsure consistent document style and adherence to company standardsBuild effective relationships with stakeholders and partners About youCore ExperienceMinimum 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 submissionsClinical Development KnowledgeBasic understanding of clinical development processesKnowledge of clinical study methodology and basic statisticsFamiliarity with regulatory environment and medical terminologyProficient in document management systems and authoring platformsProfessional AttributesStrong attention to detail and deadline managementStrong organizational and follow-up abilitiesAbility to work independently and in global teamsTechnical SkillsProficiency in electronic document management and Microsoft OfficeInterest in implementing emerging innovative digital technologies, including AI-assisted document authoring solutions.EducationAdvanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified.LanguagesIntermediate 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。nullPursue Progress. Discover Extraordinary.Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.