Senior Medical Writer

GSK

Poland
Base: pln 166,500 to pln 277,500 gross; bonus/equi...
Clinical trial design understanding
Interpretation of clinical data
Regulatory document authoring
The Senior Medical Writer is expected to work on assignments largely independently or for complex documents, under guidance of a mentor, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content

Job Summary

  • The Senior Medical Writer is expected to work on assignments largely independently or for complex documents, under guidance of a mentor, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content.
  • Authors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
  • You will gain exposure to global teams and complex clinical programs.

Matching Summary

The Senior Medical Writer is expected to work on assignments largely independently or for complex documents, under guidance of a mentor, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content.

Salary

Base: PLN 166,500 to PLN 277,500 gross; Bonus/Equity: potentially eligible for bonus and/or awards for exceptional performance; Benefits: statutory benefits, private healthcare, additional paid days off, life insurance, private pension plan, fully paid parental leave & care of family member leave

Skills & Requirements

Must-have

  • Clinical trial design understanding
  • Interpretation of clinical data
  • Regulatory document authoring
  • Proactive stakeholder coordination
  • High quality document standards

Nice-to-have

  • Ambitious for patients culture
  • Continuous learning environment
  • Global team exposure
  • Accountability for impact

Key Requirements

  • Up to 5 years clinical regulatory writing experience
  • Good understanding of basic drug development
  • Knowledge of scientific methodology and statistical principles
  • Working knowledge of ICH/GCP
  • Excellent English language skills

Work Rights

Not specified

Tailored Resume

Cover Letter