RN specializing in clinical documentation integrity for pediatric patients at Connecticut Children's. Collaborating with healthcare providers to enhance documentation standards and accuracy.
About the role
- Principal Medical Writer at GSK writing clinical documents for regulatory submissions. Collaborating with teams to ensure quality and compliance with global standards.
Responsibilities
- 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.
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