メディカルライター/メディカルライティング 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2017年 11月 22日

求人情報

メディカルライティング

求人管理No.011856

会社概要

メディカルライター

外資製薬メーカーにてメディカルライテイング業務を担当いただきます。

募集要項

■概要
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 our company to maintain fully integrated and standardized processes and systems.
・Fulfill the role of Japan Documentation Lead.

■役割
・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.

募集条件

  • ■必要な知識/スキル (Required knowledge/skills)
    ・PharmD/PhD/MD in a relevant scientific discipline, or MS/BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent.
    ・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.
    ・Significant 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.

勤務開始日

  • 応相談

採用人数

  • 若干名

雇用形態

  • 正社員

勤務地

  • 東京

転勤有無

  • 当面なし

勤務時間

  • 9:00~17:15 ※フレックスタイム制度あり

給与

  • ご経験に応じての額となります。