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 documents, 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. Synthesises trends in text and statistics to organise 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 Ph D 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 Harmonisation (ICH)/Valuable 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. Personalised 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 everyday. Free car and bike parking, locker rooms and showers. Equal Opportunity Employer 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 (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. #J-18808-Ljbffr

📌 Principal Medical Writer (Mississauga)
🏢 Anonymous
📍 Mississauga