Principal Medical Writer
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Warsaw • 🇵🇱 Poland
Visit company websiteSalary
💰 PLN 229,500 - PLN 382,500 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Proven experience writing a wide range of clinical and regulatory documents (protocols, CSRs, CTD/NDA/MAA sections, IBs, briefing docs, regulatory responses).
- Work effectively in matrix teams to deliver high-quality, fit-for-purpose documents meeting GSK and global/local regulatory standards.
- Major contributor to planning and producing clinical dossiers for international regulatory submissions.
- Managed projects of increasing scope and complexity with demonstrated effectiveness.
- Understands cross-functional interdependencies (e.g., clinical pharmacology, biomarkers, health outcomes).
- Quickly assesses complex situations and implements practical scientific, operational, and submission solutions.
- Strong technical, statistical, and IT skills with ability to interpret complex clinical data.
- Synthesizes trends in text and statistics to organize clear content and messaging in reports and summaries.
- Reviews analysis and reporting plans, advising on table content and display; familiar with review tools and automation to speed document preparation.
- Mentors junior writers, adapts to changing priorities/therapeutic areas, and communicates effectively both orally and in writing.
Requirements
- PhD or equivalent expertise (e.g., a master’s degree with relevant experience).
- 5 years clinical regulatory writing experience in the pharmaceutical industry.
- Possesses a good understanding of drug development.
- Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research.
- Clear demonstration of understanding of how to interpret, describe and document clinical data.
- Possesses working knowledge of International Committee for Harmonization (ICH)/Good Clinical Practice (GCP).
- Possesses necessary computer skills and general computer literacy.
- Excellent English language skills (verbal and written).
Benefits
- Career at one of the leading global healthcare companies.
- Contract of employment.
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit).
- Life insurance and pension plan.
- Private medical package with additional preventive healthcare services for employees and their eligible counterparts.
- Sports cards (Multisport).
- Possibilities of development within the role and company’s structure.
- Personalized learning approach (mentoring, online training platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training).
- Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).
- Supportive community and integration events.
- Modern office with creative rooms, fresh fruits every day.
- Free car and bike parking, locker rooms and showers.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical writingregulatory writingstatistical analysisdata interpretationdocument preparationproject managementscientific methodologyclinical research designdrug developmentregulatory submissions
Soft skills
communicationmentoringadaptabilityteam collaborationproblem-solvingorganizational skillscritical thinkingattention to detailtime managementinterpersonal skills
Certifications
PhDmaster’s degreeICHGCP