Fsp Medical Writer

IQVIA Inc

Japan
Fully remote
Clinical trial documentation
Regulatory submission documents
Post-marketing surveillance documents
IQVIA Inc is seeking a Fsp Medical Writer for their Japan branch, focusing on creating clinical development documents while ensuring compliance with various regulations. The ideal candidate should have a solid background in medical writing and relevant scientific knowledge, with fluency in both Japanese and English

Job Summary

  • IQVIA aims to realize a society where everyone can live healthier and more fulfilling lives by supporting those advancing healthcare with innovative solutions.
  • As a Medical Writer, you will be responsible for creating various clinical trial-related documents, including protocols, CSRs, and CTDs, following client SOPs.
  • This position offers the opportunity to gain experience in a wide range of development items across pharmaceuticals, medical devices, and regenerative medicine, with advice available from internal medical and regulatory experts.

Matching Summary

Match Score: 85

IQVIA Inc is seeking a Fsp Medical Writer for their Japan branch, focusing on creating clinical development documents while ensuring compliance with various regulations. The ideal candidate should have a solid background in medical writing and relevant scientific knowledge, with fluency in both Japanese and English.

Skills & Requirements

Must-have

  • Clinical trial documentation
  • Regulatory submission documents
  • Post-marketing surveillance documents
  • English reading and writing
  • Japanese language fluency

Nice-to-have

  • Clinical pharmacology knowledge
  • PMDA interaction experience
  • Global team collaboration

Key Requirements

  • 4+ years of Medical Writing experience
  • Bachelor's or Master's degree in a science field
  • Understanding of drug development, GCP, ICH guidelines, and domestic regulations
  • Ability to proofread English documents and translate Japanese to English

Work Rights

Not specified

Tailored Resume

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