Principal Medical Writer

GlaxoSmithKline

Poland
Base: pln 229,500 to pln 382,500 gross; bonus: eli...
Hybrid
5 years clinical regulatory writing experience
Phd or equivalent expertise required
Knowledge of ich/gcp guidelines
This role involves turning complex clinical and safety data into clear, regulatory-ready documents for global submissions

Job Summary

  • This role involves turning complex clinical and safety data into clear, regulatory-ready documents for global submissions.
  • The company offers a comprehensive reward package including annual bonuses, private medical coverage, and flexible working solutions.
  • Candidates will work closely with cross-functional colleagues including clinical, safety, regulatory, statistics, and programming teams.

Matching Summary

This role involves turning complex clinical and safety data into clear, regulatory-ready documents for global submissions.

Salary

Base: PLN 229,500 to PLN 382,500 gross; Bonus: Eligible for annual bonus based on criteria; Benefits: Private healthcare, pension plan, paid parental leave

Skills & Requirements

Must-have

  • 5 years clinical regulatory writing experience
  • PhD or equivalent expertise required
  • Knowledge of ICH/GCP guidelines
  • Experience with CTD/NDA/MAA sections
  • Ability to interpret complex clinical data

Nice-to-have

  • Collaborative mindset in matrix teams
  • Mentoring opportunities for growth
  • Familiarity with automation tools
  • Adaptability to changing therapeutic areas

Key Requirements

  • PhD or Master's degree with relevant experience
  • Minimum 5 years pharmaceutical industry experience
  • Working knowledge of International Committee for Harmonization (ICH)
  • Excellent English language skills verbal and written

Work Rights

Not specified

Tailored Resume

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