We are seeking an experienced professional with advanced medical writing expertise who can independently manage complex regulatory writing projects.
This role demands a deep understanding of clinical trial designs, statistical analysis interpretation, and clinical document processes.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK
In this role you will
Author and deliver high‑quality clinical regulatory documents, including protocols, Clinical Study Reports (CSRs), Investigator’s Brochures, briefing documents, CTD submission documents, and responses to regulatory authority questions.
Lead and contribute to the planning, development, and delivery of clinical dossier documents for global regulatory submissions, ensuring quality, consistency, and timeliness.
Partner within cross‑functional, matrix teams to produce fit‑for‑purpose documents that accurately reflect clinical and statistical data and comply with GSK standards and regulatory requirements.
Manage complex writing projects, coordinating multiple contributors and adapting plans to address evolving priorities, therapeutic areas, and submission needs.
Interpret complex clinical and statistical information, identify key trends and messages, and translate data into clear, well‑structured regulatory narratives.
Review reporting and analysis plans, provide critical input on tables and data presentation, and apply efficient document development approaches, including review tools and automation.
Why you?
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
PhD or equivalent relevant experience within the life sciences.
Advanced experience in clinical regulatory medical writing within the pharmaceutical industry.
Demonstrated ability to independently author complex regulatory documents and lead or significantly contribute to CTD submission dossiers, including Module 2 documents.
Strong understanding of clinical trial design, regulatory requirements, statistical concepts, and interpretation of clinical data.
Proven leadership capability with experience influencing and collaborating effectively in global, multicultural, and matrixed environments.
Working knowledge of ICH guidelines, Good Clinical Practice (GCP), and strong written and verbal English communication skills.
Closing Date for Applications – 2nd July 2026
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
As a focused biopharma company, we discover, develop and deliver medicines and vaccines to create value for patients and shareholders. We are on track to make a positive impact on the health of 2.5 billion people by the end of the decade. In R&D, we combine the science of the immune system with advanced technologies to develop new medicines and vaccines that can help transform people’s lives. We focus on four areas – respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – where we have the strongest expertise and significant patient need remains. By developing differentiated medicines and vaccines across these areas, we can deliver patient benefit at scale and generate value for people, health systems, shareholders and society.
Find out more:
Our approach to R&D .
#LI-GSK
Skills
Clinical Development, Clinical Trial Designs, Communication, Customer Service, Decision Making, Emotional Intelligence, Influencing Without Authority, Learning Agility, Literature Reviews, Medical Writing, Pharmaceutical Industry, Presentation Techniques, Regulatory Submissions, Scientific Writing, Strategic Thinking
In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD118,000 to CAD168,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [email protected] where you can also request a call.
Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide.
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