Join to apply for the Principal Medical Writer role at GSK

Site Name: Warsaw, Mississauga Milverton Drive

Posted Date: Sep 11 2025

The Principal Medical Writer is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trial designs and interpretation of statistically analyzed research data. He/she is expected to drive and coordinate the process to draft, review and approve written assignments including marketing application submission documents. The role requires extensive clinical document expertise and will support continuous improvement and the implementation of best practices.

Key Responsibilities include, but are not limited to:

• Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
• Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect data and align with GSK standards and global, regional and/or local regulatory requirements.
• Experience as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
• Demonstrated effectiveness in managing projects of increasing scope and complexity.
• Understanding of interdependencies of contributing functions (e.g., clinical pharmacology, biomarkers, health outcomes).
• Ability to assess complex situations, apply scientific, operational, and submission development knowledge, and implement effective solutions.
• High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
• Assess trends and patterns in text and statistical data, and effectively organize content and messages in clinical reports and summary documents.
• Review reporting and analysis plans and provide critical input on the content and display of tables.
• Familiarity with approaches to expedite document preparation such as review tools and automation.
• Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., support documents in different therapeutic areas).
• Effectiveness in both oral and written communications.

Required Qualifications:

• PhD or relevant working experience within the life sciences space.
• Clinical regulatory writing experience in the pharmaceutical industry.
• Demonstration of leadership.
• Experience in multicultural settings (to reflect external customers/clients and diverse environments with respect to dynamics of human interaction, including working with remote teams).
• Ability to interpret, describe and document clinical data.
• Working knowledge of ICH/GCP.
• Computer skills and general computer literacy.
• Excellent English language skills (verbal and written).

Why GSK?

• Career at one of the leading global healthcare companies
• Contract of employment
• Hybrid working model (GSK sites in Poland)
• Extensive support of work-life balance (flexible working solutions, min. 2-3 days/week in the office, short Fridays option, health & wellbeing activities)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services
• Sports cards (Multisport)
• Opportunities for development within the role and company structure
• Personalized learning approach (internal trainings, mentoring, access to online trainings and platforms)
• Supportive community and integration events
• Modern office with creative spaces

Inclusion at GSK: As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, pregnancy, gender identity, sexual orientation, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.