Principal Medical Writer Job – at GSK, Apply Now!
Are you a seasoned medical writer ready to make a global impact? GSK is hiring a Principal Medical Writer across locations in Poland, India, and Canada. This role requires advanced regulatory writing experience and a deep understanding of clinical trial designs. Join one of the world’s leading healthcare companies and be part of a diverse, supportive, and innovation-driven environment where your expertise helps shape life-saving therapies.
Job Title: Principal Medical Writer
Multiple Locations: Warsaw, Poland; Bengaluru, India; Mississauga, Canada
Categories: Medical and Clinical
Req ID:419843
The Principal Medical Writer at GSK is an expert contributor responsible for independently executing complex writing assignments related to clinical trials and regulatory documents. The ideal candidate will have advanced experience in regulatory medical writing, a strong background in oncology, and a deep understanding of clinical pharmacology concepts.
Key Responsibilities for Medical Writer:
- 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 associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
- Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
- Demonstrated effectiveness in management of projects of increasing scope and complexity.
- Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome).
- Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions.
- High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data as Medical Writer.
- Assess trends and patterns in text and statistical data, and effectively organizes content and messages in clinical reports and summary documents.
- 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 review tools and automation.
- 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 preferred for Medical Writer.
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 our external customers/clients [health authorities/patients] and diverse environments with respect to dynamics of human interaction (including working with remote teams)
- Ability to interpret, describe and document clinical data required for Medical Writer.
- Working knowledge of International Committee for Harmonisation (ICH)/Good Clinical Practice (GCP).
- Computer skills and general computer literacy.
- Excellent English language skills (verbal and written)
Why GSK?
- Career at a leading global healthcare company.
- Attractive reward package and benefits.
- Hybrid working model.
- Support for work-life balance and well-being.
- Opportunities for career development and personalized learning.
Keywords: GSK job, Principal Medical Writer, clinical regulatory writing, pharmaceutical industry, GSK recruitment
