Us To Help Unite Science Technology
Healthcare
PrincipalMedicalWriter
Neural analysis suggests this role is
optimal for Senior candidates.
“Principal Medical Writer at Us To Help Unite Science Technology. Skills: Clinical regulatory writing, Regulatory submissions, Data interpretation. Write clinical and regulatory documents. Work in matrix teams”
Industry & Context.
Practical problem solving; Problem solving
What They're Looking For.
Must Have
5 years clinical regulatory writing experience, PhD or equivalent expertise, Master's degree with relevant experience, Working knowledge of ICH/GCP, Necessary computer skills, General computer literacy, Excellent English language skills
Nice to Have
PhD or equivalent expertise
What You'll Do.
Write clinical and regulatory documents
Deliver fit-for-purpose documents
Meet regulatory standards
Plan clinical dossiers
Produce clinical dossiers
Assess complex situations
Implement scientific solutions
Implement operational solutions
Implement submission solutions
Interpret complex clinical data
Synthesize trends in text
Synthesize trends in statistics
Organize content in reports
Organize messaging in summaries
Review analysis plans
Review reporting plans
Advise on table content
Speed document preparation
Mentor junior writers
Adapt to changing priorities
Adapt to changing therapeutic areas
Communicate in writing
How You'll Work.
Team & Collaboration
Matrix teams
Communication Scope
Oral communication; Written communication
Process & Methodology
Project management
Full Job Description
You will be a Principal Medical Writer who turns complex clinical and safety data into clear, regulatory-ready documents. You will work closely with clinical, safety, regulatory, statistics and programming colleagues. We value sound scientific judgement, practical problem solving and a collaborative mindset. This role offers growth through exposure to global submissions, process improvement and mentoring opportunities. Join us to help unite science, technology and talent to get ahead of disease together. **Key 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. **Qualifications and Experience** : * 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. * Demon
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