【astrazeneca】【r&d】clinical Regulatory Writer (crew), 研究開発本部 薬事統括部 薬事オペレーション部 クリニカル レギュラトリー ライティング スタディドキュメントグループ

astrazeneca

Medical writing skill/experience
Drug development processes knowledge
Gcp, ich gls knowledge
Clinical Regulatory Writer (CReW) is responsible for the authoring of clinical-regulatory documents that communicate the evidence base of product knowledge in a credible, consistent and compliant way

Job Summary

  • Clinical Regulatory Writer (CReW) is responsible for the authoring of clinical-regulatory documents that communicate the evidence base of product knowledge in a credible, consistent and compliant way.
  • CReW leads the authoring of the clinical parts of documents such as CSP / MICF / CSR / IB, in line with the project communication strategy, and ensure quality and efficiency in delivery.
  • AstraZeneca embraces diversity and equality of opportunity and is committed to building an inclusive and diverse team representing all backgrounds.

Matching Summary

Clinical Regulatory Writer (CReW) is responsible for the authoring of clinical-regulatory documents that communicate the evidence base of product knowledge in a credible, consistent and compliant way.

Skills & Requirements

Must-have

  • Medical Writing Skill/Experience
  • Drug development processes knowledge
  • GCP, ICH GLs knowledge
  • Logical thinking/Presentation skill
  • Interpersonal and communication skills
  • Facilitation skill

Nice-to-have

  • Leading documentation strategy
  • Regulatory submissions experience
  • Supervising internal communications
  • Digital tools and technologies

Key Requirements

  • Medical Writing Skill/Experience
  • Knowledge of drug development processes
  • Bachelor’s Degree in Science
  • Native level Japanese
  • Reading & Writing English

Work Rights

Not specified

Tailored Resume

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