現在の求人検索条件でメールをお届けします。

利用規約に同意する

※希望条件に合致した求人が掲載されましたら、1日1回メールにてお知らせいたします。

※希望求人メールの解除はこちら

NEW 2017年11月15日 ID:YFMW21

メディカルライター

  • 企業名非公開
  • 株式会社メディサーチ
  • 株式会社メディサーチ
会社情報
業種 製薬企業
会社概要 革新的新薬の創出に特化した外資系スペシャリティファーマ
基本情報
募集職種 開発企画/メディカルライター
仕事内容 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 ●●KK and GRD 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.
応募資格 必要な知識/スキル
・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 lead
勤務地 東京都
年収・給与 前年収考慮の上、社内規定により決定

担当コンサルタントより

  • 藤川 靖宏
  • 株式会社メディサーチ 藤川 靖宏

この求人へ問い合わせ

注目のキーワード

ページの
上部へ