大手外資系製薬会社

＜Overview＞
- Lead the authoring of clinical/regulatory documents and support the performance goals (including quality and timeline) for filing regulatory dossiers in Japan as planned by the R&D Development Teams.
- Establish cooperative partnership with other functions within BMKK and GRD to maintain fully integrated and standardized processes and systems.
- Fulfill the role of Japan Documentation Lead.

＜Roles & responsibilities＞
- 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.

＜役割＞
-日本法人、グローバルHQ、共同開発会社の医薬品開発チームと協業し、得られた専門的なコメントやアドバイスを元に、臨床試験の結果に科学的・医学的解釈を加えながら、CTD M2.5、M2.7.3/2.7.4、M2.7.6等の薬事文書を作成する。
-上記文書作成に際し、スケジュール作成・管理を行う。
-必要に応じ、他の関連文書（機構相談資料、治験実施計画書、治験総括報告書等）をレビューする。

- 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.

-製薬企業 開発部門において、3～5年以上の臨床又は薬事関連文書の執筆経験（臨床試験の立案、機構相談資料作成、１つ以上の申請業務等）、若しくは同等の知識・経験を有する者
-国内外の規制要件やガイドラインに関する知識
-英文リーディング及びライティング・スキル
-海外の開発スタッフとのメールや電話会議でのコミュニケーション
-臨床試験の結果（データ）の分析・解釈
-クロスファンクショナルなチームメンバーとの協働に必要な、プランニング、タイムマネジメント、コーディネーション等のスキル
-CROや翻訳ベンダーのマネージメント経験