Principal Medical Writer

Mississauga Milverton Drivelead

Medical WriterLaboratory & Life Sciences

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Quick Summary

Key Responsibilities

Independently lead preparation of complex clinical and post-market safety documents (e.g., DSURs, PSURs/PBRERs, ACOs, PADERs/PAERs, RMPs, and responses to regulatory authority questions),

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Medical WriterLaboratory & Life Sciences

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
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Our approach to R&D

Position Summary

The Principal Medical Writer is a seasoned expert who owns complex safety writing deliverables end-to-end. In this role, they independently lead the authoring of high-impact safety documents—such as aggregate reports and Risk Management Plans (RMPs)—translating complex safety data and analyses into clear, compelling outputs. They are accountable for driving timelines, managing stakeholders, and ensuring the quality of safety deliverables that address important safety issues. Beyond day-to-day delivery, this role is a key champion for continuous improvement, best practices, and the smart adoption of new tools and technologies in the safety writing space.

Responsibilities

~2 min read

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

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Independently lead preparation of complex clinical and post-market safety documents (e.g., DSURs, PSURs/PBRERs, ACOs, PADERs/PAERs, RMPs, and responses to regulatory authority questions), with strong hands-on experience across all key aggregate safety documents.
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Operate effectively within a global, complex matrix organization, working autonomously and confidently influencing stakeholders on process discipline, quality standards, and “how” work should be done.
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Lead cross-functional teams to develop content strategy, coordinate contributions, manage review schedules and timelines, and ensure high-quality, fit-for-purpose documents that accurately reflect safety, clinical, and statistical data and meet GSK and global/regional/local regulatory requirements.
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Provide oversight to co-authors, vendor writers, and teams of writers—serving as a mentor/buddy, ensuring the quality of contributions, and leading initiatives to improve medical writing processes, including effective use of authoring/review tools and other automation/AI-enabled technology platforms.

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.

This role is hybrid. You will work on-site in Canada part of the week and remotely the remainder. Exact on-site days will be agreed with your manager.

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. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.