Principal Medical Writer, Safety

Job Title: 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
The Principal Medical Writer is a senior subject-matter expert who independently drives the creation of high-stakes safety documents—such as aggregate reports and Risk Management Plans—by combining deep regulatory knowledge with sharp interpretation of safety data. This role leads end-to-end production of complex deliverables, navigates challenging data analyses and critical safety issues, and champions continuous improvement by promoting best practices and adopting new tools and technologies.

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, including but not limited to Development Safety Update Reports (DSURs), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs), Addendums to Clinical Overviews (ACOs), US Periodic Adverse Drug Experience Reports/Periodic Adverse Experience Reports (PADERs/PAERs), RMPs and responses to regulatory authority questions.
• Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions.
• Lead cross-functional teams in document preparation including but not limited to development of content strategy, coordination of content contributions, organization of review schedules, and project timelines.
• Work in a matrix team to ensure delivery of high-quality, fit-for-purpose documents that reflect accurate interpretation of associated safety, clinical, and statistical data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
• Understand the interdependencies of various contributing functions (e.g., safety, regulatory, clinical, epidemiology, statistics and programming).
• Anticipate and evaluate complex situations and problems, resolving them by leveraging scientific and operational knowledge in collaboration with stakeholders.
• Assess trends and patterns in text and statistical data and effectively organize content and messages in safety documents.
• Use approaches to expedite document preparation, including authoring and reviewing tools, as well as other automation/technology platforms.
• Serve as a mentor for less experienced writers.
• Develop and deliver training on medical writing topics.
• Lead initiatives to improve medical writing processes.
• Contribute to vendor oversight as needed.

Why You?
Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• Bachelor's degree or equivalent in a scientific discipline.

• 5 years of advanced safety writing experience in the pharmaceutical domain including summarization and interpretation of complex data and preparation of complex documents.
• Experience authoring relevant regulatory guidance (e.g., ICH, GVP, FDA, EMA) pertaining to clinical trial conduct, pharmacovigilance, and document-specific requirements and core cross-functional clinical research roles and procedures, and how they relate to document strategy and operational preparation.
• Experience in multiple therapeutic areas to have confidence to dive into these areas without lead time.
• Advanced understanding of and ability to apply the statistical, regulatory, and medical communication concepts needed to independently write complex safety documents

​Preferred Qualification

If you have the following characteristics, it would be a plus

• Advanced safety writing skills with expertise in most safety document types.
• Experience in a highly collaborative environment, leading cross‐functional team members, negotiating solutions, and advising them on document structure and content as needed.
• Skilled in navigating multicultural settings, ensuring effective collaboration with diverse customers and clients, such as health authorities and patients, while adeptly collaborating with remote teams.
• Able to independently lead multiple projects simultaneously and deliver multiple high-quality documents on schedule.
• Advanced computer skills and general computer literacy.
• Excellent English language proficiency, both verbal and written.

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

What you will gain
You will gain exposure to complex development programs and deepen skills in regulatory writing, submission planning and cross-functional collaboration. You will work with talented colleagues who value inclusion, learning and patient-focused impact.
Ready to apply?
If this role aligns with your skills and goals, we want to hear from you. Please apply and tell us how your experience will help shape treatments that matter.

#LI-Hybrid

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.

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