Regulatory Submission

2ヶ月前

Minato, Shizuoka Barrington James

〈必須スキル/経験〉

Regulatory Submission Lead

  • 製薬業界での経験:

  • Sr. Associate:5年以上

  • Consultant:8〜10年以上(薬事オペレーションに特化した経験)

※電子試験データを含む主要申請に対応できること

  • eCTDの作成・提出・文書管理に関する経験:
  • Sr. Associate:5年以上

  • Consultant:8〜10年以上

  • グローバルRegulatory Information Management(RIM)または関連システムの経験:

  • Sr. Associate:3年以上
  • Consultant:5年以上
  • 規制関連のシステム導入支援の経験(例:Documentum、Veeva Vault、Insight Manager / Publisher、docuBridge など)
  • Officeツール(Excel、Word、PowerPoint、Visio)、Adobe Acrobat、Evermap、ISI Toolbox、eCTD Publishingツールの使用が可能
  • 日本語・英語ともに流暢であること

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