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メディカルライター(FSO Medical Writer/ IQVIA Services)

IQVIA · Tokyo, Japan +1 more

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Medical AffairsFull-timeCompany career page

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Role summary

IQVIA seeks a medical writer to develop clinical trial documents, post-marketing reports, and regulatory submissions across diverse therapeutic areas. The role involves creating and reviewing pharmaceutical documentation while collaborating with internal medical and regulatory experts in a global environment.

What they're looking for

  • Practical medical writing experience (translation-only background excluded)
  • Bachelor's or master's degree in science discipline
  • Foundational knowledge of pharmaceuticals and medical science
  • Understanding of drug development, GCP, ICH guidelines, and domestic pharmaceutical regulations
  • English reading and writing capability for document review and translation
  • Fluent Japanese language skills
  • Non-clinical (pharmacology, toxicology, ADME) or clinical pharmacology knowledge (preferred)

What you'll be doing

  • Create clinical trial-related documents including protocols, summaries, and technical dossiers
  • Adapt global trial protocols to meet Japanese regulatory requirements
  • Develop post-marketing surveillance and re-examination application materials
  • Write clinical research reports and manuscripts
  • Conduct quality control reviews of various documents

Privacy & handoff

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What RoleLantern checked

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RoleLantern checkedNeeds clarity
Date posted16 days ago
Last source check1 day ago
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