Principal Medical Writer Business Introduction 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 Are you passionate about creating high-quality medical and scientific documents that make a meaningful impact? In this role, you will lead the development of complex regulatory documents, ensuring they meet global standards and support GSK’s mission to get ahead of disease together. You’ll collaborate with cross-functional teams, contribute to regulatory submissions, and help shape the future of medical writing at GSK. This is an opportunity to grow your expertise, work on impactful projects, and be part of a team that values innovation, inclusion, and excellence. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: - Lead the development of clinical regulatory documents, including protocols, clinical study reports, investigator brochures, and regulatory submission documents. - Collaborate with cross-functional teams to ensure documents are accurate, clear, and aligned with regulatory requirements. - Manage timelines and deliverables for multiple projects, ensuring high-quality outputs within deadlines. - Provide strategic input into clinical development plans and regulatory submission strategies. - Mentor and guide junior medical writers, fostering a culture of continuous learning and improvement. - Identify opportunities to enhance processes and implement best practices in medical writing. 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, or a related field. - At least 7 years of experience in medical or scientific writing within the pharmaceutical or healthcare industry. - Proven ability to independently write and manage complex regulatory documents. - Strong understanding of International Council for Harmonization (ICH) guidelines and Good Clinical Practice (GCP). - Excellent written and verbal communication skills, with attention to detail. - Experience managing multiple projects and meeting deadlines in a fast-paced environment. Preferred Qualifications If you have the following characteristics, it would be a plus: - Advanced degree (e.g., PhD, PharmD, MPH, MS) in life sciences or a related field. - Experience leading regulatory submission projects, including Common Technical Document (CTD) dossiers. - Familiarity with statistical concepts and ability to interpret clinical data. - Strong problem-solving skills and ability to adapt to changing priorities. - Experience working in multicultural or remote team settings. - Demonstrated ability to mentor and develop team members. This role is hybrid, with flexibility to work on-site 2-3 days a week in our Mississauga office. Ready to make a difference? Apply today and join us in shaping the future of healthcare! 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. 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. Important notice to Employment businesses/ Agencies 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. We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.
