Principal Medical Writer

Description

The company is a global biopharma business that develops vaccines and medicines, with a stated aim of improving the health of 2.5 billion people by the end of the decade.

The Principal Medical Writer is an experienced specialist who takes complex safety writing deliverables from start to finish. You will author high-impact safety documents such as aggregate reports and Risk Management Plans, turning complicated safety data and analyses into clear, persuasive material. You will set timelines, manage stakeholders and maintain quality for deliverables covering important safety issues. Beyond delivery, you will help drive continuous improvement, best practice and sensible adoption of new tools in safety writing.

The company runs its R&D around discovering and delivering vaccines and medicines, pairing its knowledge of the immune system with advanced technology.

Find out more about the company's approach to R&D.

Responsibilities

• Lead the writing of complex clinical and post-market safety documents on your own, such as DSURs, PSURs/PBRERs, ACOs, PADERs/PAERs, RMPs and answers to regulator questions.
• Bring hands-on experience across all key aggregate safety documents.
• Work autonomously in a global, complex matrix organisation, influencing stakeholders on process discipline, quality standards and how work gets done.
• Lead cross-functional teams on content strategy, contributions, review schedules and timelines, ensuring documents are high quality, fit for purpose, reflect safety, clinical and statistical data, and meet company and global, regional and local regulatory requirements.
• Oversee co-authors, vendor writers and writing teams, acting as mentor or buddy and checking the quality of their contributions.
• Lead efforts to improve medical writing processes, including use of authoring and review tools and automation or AI-enabled platforms.

Requirements

• Bachelor's degree in life sciences, health sciences, pharmacy, nursing or a related field.
• At least 5 years of advanced medical or regulatory safety writing experience in pharmaceutical, biotech or clinical research, including summarising and interpreting complex data and preparing complex clinical and safety documents for regulatory use.
• Advanced grasp of statistical, regulatory and medical communication concepts, and the ability to apply them to write complex safety documents without close supervision.
• In-depth working knowledge of relevant regulatory guidance such as ICH, GVP, FDA and EMA covering clinical trial conduct, pharmacovigilance and document-specific requirements, plus Good Clinical Practice (GCP).
• Solid understanding of core cross-functional clinical research roles and procedures, including safety, regulatory, clinical, epidemiology, statistics and programming, and how they shape document strategy and preparation.
• Experience across multiple therapeutic areas, and the confidence to move quickly into new ones.
• Proven record of managing several projects and deadlines in a fast-moving global matrix setting, working autonomously while influencing stakeholders.
• Strong written and spoken English and excellent attention to detail.
• Preferred: an advanced degree (PhD, PharmD, MSc, MPH) or equivalent scientific training.
• Preferred: advanced safety writing skills across most key safety document types, and experience leading regulatory submissions or preparing dossier modules.
• Preferred: comfort interpreting statistical outputs and working with statisticians on tables and data displays.
• Preferred: experience leading cross-functional, multicultural and hybrid or distributed teams across regions, negotiating solutions, advising on structure and content, and engaging diverse stakeholders such as health authorities, external partners, CROs, contractors and patients.
• Preferred: experience working with external partners, contractors or CROs, including vendor oversight and coordination.
• Preferred: prior mentoring, training or people development experience, helping less experienced writers grow.
• Preferred: ability to lead several projects at once and deliver multiple high-quality documents on time.
• Preferred: advanced computer skills and general computer literacy, including comfort with collaboration and remote-working tools.
• Preferred: excellent verbal and written English.
• Skills listed: 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.
• The company is a global biopharma business focused on respiratory, immunology and inflammation, oncology, HIV, and infectious diseases.
• The company does not accept candidate referrals from employment businesses or agencies without prior written authorisation from its commercial and general procurement or HR department. Any fees arising from unauthorised referrals will not be payable.

Conditions

This role is hybrid, based in Canada: you will work on-site part of the week and remotely the rest, with exact on-site days agreed with your manager.

Pay is CAD118,000 to CAD168,000 per year in Ontario, depending on experience, qualifications and internal equity.

Salary ranges for other locations are published where local pay transparency law requires them, and otherwise are discussed during recruitment.

The company is committed to fair and transparent hiring.

Benefits

• You will develop technical and strategic skills in regulatory writing, submission planning and cross-functional collaboration.
• Your work will shape development programmes and help improve outcomes for patients.