Principal Medical Writer

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About the role

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. Find out more: 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 This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • 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. • 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. • 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. • 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. Why You? 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. Basic Qualifications We are seeking professionals with the following required skills and qualifications to help us achieve our goals • Bachelor’s degree in life sciences, health sciences, pharmacy, nursing or a related field. • Minimum 5 years of advanced medical/regulatory safety writing experience in pharmaceutical, biotech or clinical research settings, including summarization and interpretation of complex data and independent preparation of complex clinical and safety documents for regulatory use. • Advanced understanding of, and ability to apply, statistical, regulatory and medical communication concepts needed to independently write complex safety documents. • In-depth working knowledge of relevant regulatory guidance (e.g., ICH, GVP, FDA, EMA) pertaining to clinical trial conduct, pharmacovigilance, and document-specific requirements, as well as Good Clinical Practice (GCP). • Strong understanding of core cross-functional clinical research roles and procedures (e.g., safety, regulatory, clinical, epidemiology, s

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