メディカルライティング - バイオ医薬品メーカー

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Company Description]
外資系バイオ医薬品メーカー

  • 神経・血液・免疫の領域に重点を置いており、遺伝的要因で発症する疾患や難病でまだ治療薬がない疾患、に果敢に取り組んでいます
  • 規模が小さい会社なので個人の裁量権が高い・自分で考えて工夫できます
  • 社長と交流の機会が設けられており、和気あいあいな文化です

[Responsibilities]
Contribution as a medical writer in his/her expertise mainly clinical parts for all regulatory documents (CTD, briefing document for consultation, etc.) and positive involvement in strategic regulatory discussion during entire drug development process and also J-NDA from submission to approval for company's programs

  • Preparation of CTD in module 2 (clinical parts) and module 5 as well as parts of module 1
  • Preparation of briefing document (BD) for PMDA Consultation regardless informal and formal
  • Preparation of response documents to PMDA questions during approval review, PMDA consultation, etc.
  • Communication with global teams to get necessary information and supports
  • Vendor management necessary for all document preparation including translation and edition

[Requirements]

  • Intermediate experience (around 5 years) of medical writer in global drug development including submission/approval and launch of new products
  • Life Science bachelor degree
  • Solid experience in medical writing with scientific information in his field
  • Knowledge of regulatory filing strategy in Japan
  • A talent of writing sense in English and Japanese
  • Computer literate
  • Skill of time management
  • Skill of vendor management

[Employment Type]
Full time

[Salary]
8M-14M yen
※Experiences and skills will be considered

[Location]
Tokyo


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