Principal Medical Writer

Site Name: Warsaw, Poznan
Posted Date: Apr 24 2024

Principal Medical Writer

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 would be expected to drive and coordinate the process to draft, review and approve written assignments including marketing application submission documents. He/she has the ability to plan and prioritize without supervision. This role requires extensive clinical document expertise and will support continuous improvement and the implementation of best practices.

• Author and lead the preparation of 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 and ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements
• Contribute significantly in planning and production of clinical dossier documents for regulatory submissions worldwide
• Assess and interpret complex clinical and statistical data, and effectively organizes content and messages in clinical reports and summary documents.
• Manage projects of increasing scope and complexity ; apply scientific, operational, and submission development knowledge and implement effective plans for solutions
• Understand the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome)
• Review reporting and analysis plans and provides critical input on the content and display of tables
• Familiarity with approaches to expedite document preparation such as automation and review tools
• Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas)
• Effectiveness in both oral and written communications

• PhD or master's degree in Life Science field or equivalent expertise
• Preferably at least 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)

• 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).
• Extensive support of work life balance (flexible working solutions, min. 2 days/week working form the office, health & well-being activities).
• Life insurance and pension plan.
• Private medical package with additional preventive healthcare services for employees and their eligible.
• Sports cards (Multisport).
• Possibilities of development within the role and company's structure.
• Personalized learning approach (internal trainings, mentoring, access to online training' platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training).
• Supportive community and integration events.
• Modern office with creative rooms, fresh fruits every day.