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開発薬事コンサルタント// RA Consultant

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医療業界向けサービス企業にて開発薬事コンサルタントの募集です。オフィス勤務と在宅勤務の両方が可能です。外部企業から受領する医薬品・医療機器などの臨床試験実施計画書を元に、国内での臨床試験実施計画書の作成に携わっていただきます。勤務地は東京都または大阪府です。

職務内容:

  • 日本国内での臨床試験実施計画書をリードし、あるいは中心者をサポートして作成
  • 顧客が考える日本での開発戦略と日本の薬事規制のギャップを分析し、リスク評価・代案・薬事パスウェイ等の提案をリードし、あるいは中心者をサポートしてレポート作成
  • 品質・非臨床試験・臨床試験等に関するPMDAとの事前面談や対面助言を計画し、顧客から提供された資料を基に必要資料をリードし、あるいは中心者をサポートして作成、PMDA相談を実施
  • 治験届に必要なドキュメントをリードし、あるいは中心者をサポートして作成し、PMDAへ治験届を提出
  • PMDAからの照会事項に対する回答書を顧客と相談しながら作成・提出
  • 治験国内管理人業務の一部を遂行

応募要件:

  • 大卒、大学院卒
  • 下記いずれかの経験5年以上
    ‐ 開発薬事業務
    ‐ クリニカルモニタリング業務
    ‐ プロジェクト マネージャー業務
    ‐ メディカルライティング業務
  • ビジネスレベルの日本語力
  • 英語力(TOEIC750点以上もしくは同等のレベル)

会社概要:

医療業界向けサービス企業。グローバル規模で新薬開発に関わる支援サービスを行っている、注目の企業です。積極的な業務展開を目指す社風から、活気あふれた職場環境となっております。

求人番号: 1XYC5H

Contract Type: Perm

Specialism: Healthcare

Focus: Pharmacovigilance

Industry: Medical and Nursing

Salary: Up to ¥10,000,000 per annum

Workplace Type: On-site

Experience Level: Associate

Language: Japanese - Professional working

Second Language: English - Business level

Location: Tokyo

Job Reference: 1XYC5H-87F6BEDD

Date posted: 1 July 2025

Consultant: Norika Basyal