Medical Writer

Company Overview
■世界ランキング上位に入る米国製薬メーカー
■成長性のある多くの新薬パイプライン保有
■福利厚生充実、安定して働ける環境

Job Description
- A senior level scientific writer who creates basic clinical/regulatory documents (e.g. CTD M2.7.6), complex clinical/regulatory documents (e.g. CTD M2.7.3/2.7.4, CSR) and high level clinical/regulatory documents (e.g. CTD M2.5, responses to Health Authority) independently, ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members.
- Coordinate translation of IBs to Japanese.
- Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for clinical/regulatory documents of assigned projects.
- Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
- Review and edit other clinical/regulatory documents as required.
- Supervise other scientific writers and improves their capabilities in creation of clinical/regulatory documents for Japan.
- Maintain document prototypes and shells.

Requirements
- Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.
- Demonstrated strong writing skills both in Japanese and in English, preferably in authoring and leading the production of clinical/regulatory documents for submission to PMDA.
- Ability to analyze and interpret complex data from a broad range of scientific disciplines.
- Experience in authoring clinical/regulatory documents, including high‐level CTD Module 2 clinical summaries, and participation in at least one major JNDA filing.
- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
- Working knowledge of a document management system.
- Skills to appropriately manage CROs or translation vendors.
- Skills to read scientific documents in English and communicate with the global members.
- MS/BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent.

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