Main responsibilities
Document Development
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Create high-quality regulatory-compliant clinical documents supporting product life cycle under supervision
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Ensure timely delivery while maintaining compliance with company SOPs and guidelines
Innovation
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Learn and adopt new digital technologies, AI solutions, and efficient processes
Regulatory Expertise
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Prepare clinical documents for registration dossiers and Health Authority responses under structured guidance and close supervision of senior medical writers
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Maintain awareness of regulatory documentation requirements
Communication
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Work effectively with cross-functional teams
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Escalate complex issues to senior team members
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Report progress of document preparation to the supervisor
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Update relevant stakeholders on project progress and needs
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Maintain accurate information in planning, tracking, and reporting tools
Coordination
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Support coordination with vendor medical writers under supervision
Quality & Training
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Ensure consistent document style and adherence to company standards
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Build effective relationships with stakeholders and partners
Knowledge And Skills:
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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.
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Former experience as a Medical writer or in a position in Clinical Research
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A basic understanding of, preferably also experience in basic statistics and experimental research.
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Intermediate or higher English skill including writing, reading, listening and speaking.
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Respect of guidelines and internal processes
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Ability to work effectively in a multicultural, multilingual setting is required.
About you
Core Experience:
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Minimum 3 years’ experience in Clinical Development or equivalent, with limited or no prior medical writing experience
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Ability to clearly, accurately, and concisely write/prepare clinical documents in English and Japanese
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Basic experience in reviewing or contributing to clinical documents
Clinical Development Knowledge:
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Basic understanding of clinical development processes
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Knowledge of clinical study methodology and basic statistics
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Familiarity with regulatory environment and medical terminology
Professional Attributes:
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Willingness to learn medical writing principles and practices
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Strong attention to detail and deadline management
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Strong organizational and follow-up abilities
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Ability to work independently and in global teams
Technical skills:
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Proficiency in electronic document management and Microsoft Office
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Interest in implementing emerging innovative digital technologies, including AI-assisted document authoring solutions
Education:
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Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified.
Languages:
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Intermediate or higher level in written and spoken English.
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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。
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