Sr. Medical Writer at Top Global Biopharma (Tokyo or Osaka)

東京23区 外資系企業 年収 1000万円 - 1500万円 外資系企業 在宅可・ハイブリッド勤務可
  • One of the top global biopharma supporting various unmet medical needs
  • Lead in authoring clinical regulatory documents and submissions successfully

企業情報

  • One of the largest leading biopharmaceutical company in the industry
  • Rich development pipeline specialising in oncology, immunology, vaccines, CNS, etc. for unmet medical needs
  • Highly patient-centric focused for new drug development to deliver cutting edge products/therapies
  • Global working environment with continuous interactions with global stakeholders
  • Hybrid working style

職務内容

  • Take lead in authoring essential clinical regulatory documents for submission effectively obtain/maintain product development approval
  • Take charge in documents such as CTD, IB, CSR, CSP, MICF, and other critical documents to align business objectives
  • Ensuring overall quality of documents are up to company standards to help support for PMDA consultations
  • Review other essential documents such as translation to product labels and other overall communication

理想の人材

  • University degree in a scientific or related area
  • Medical writing experience in the pharmaceutical industry
  • Ability to translate documents successfully
  • Deep knowledge of overall drug development process and up to date regulations/guidelines
  • Exposure to regulatory submissions to PMDA/MHLW as well as responding to inquiries
  • High fluency in English or Japanese (Non-native level speakers will not be selected)

条件・待遇

  • Competitive salaries and benefits
  • Global working environment
  • Great work life balance
  • Amazing career progression in medical writing
  • Work with industry leaders who are solving various unmet medical needs
コンタクト
Zach Itozu
求人番号
JN-092023-6189318
電話
+813 6832 8683

求人情報

分野
ライフサイエンス
職種
製薬
業界
ヘルスケア・製薬
勤務地
東京23区
雇用形態
正社員
担当コンサルタント
Zach Itozu
担当コンサルタントの電話番号
+813 6832 8683
求人番号
JN-092023-6189318
企業タイプ
外資系企業
勤務形態
在宅可・ハイブリッド勤務可

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