Senior Medical Writer

Description:

GSK is seeking an experienced Principal Medical Writer specializing in Safety Writing to join their Mississauga team. The role is ideal for an expert contributor capable of independently executing complex writing assignments, particularly those involving clinical and post-market safety documents. This position demands a thorough understanding of safety data and documents such as aggregate reports and Risk Management Plans (RMPs), and requires extensive expertise to produce high-quality deliverables while supporting process improvements and adoption of new tools and technologies.

Key Responsibilities:

• Independently lead preparation of complex safety documents, including Development Safety Update Reports (DSURs), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs), Addendums to Clinical Overviews (ACOs), US PADERs/PAERs, RMPs, and responses to regulatory authority questions.

• Provide oversight to co-authors or teams of writers, ensuring the quality of their contributions.

• Lead cross-functional teams in document preparation, including content strategy development, coordination of contributions, review schedule management, and project timeline adherence.

• Ensure delivery of high-quality, fit-for-purpose documents reflecting accurate interpretation of safety, clinical, and statistical data in line with GSK standards and global, regional, and local regulatory requirements.

• Anticipate and resolve complex situations leveraging scientific and operational knowledge.

• Analyze text and statistical data to organize content effectively in safety documents.

• Utilize tools, automation, and technology platforms to expedite document preparation.

• Mentor less experienced writers and provide training on medical writing topics.

• Lead initiatives to improve medical writing processes and contribute to vendor oversight as required.

Education Requirements:

• Master’s degree or equivalent in a scientific discipline.

• Degrees in Medicine, Dentistry, Physiotherapy, or Experimental Medicine involving patient exposure in hospital-based environments are advantageous.

Job-Related Experience & Skills:

• Minimum 7 years of advanced safety writing experience, including summarization, interpretation of complex data, and preparation of complex documents.

• In-depth knowledge of regulatory guidance (e.g., ICH, GVP, FDA, EMA) related to clinical trials, pharmacovigilance, and document-specific requirements.

• Advanced understanding of cross-functional clinical research roles and document strategy.

• Experience in multiple therapeutic areas.

• Advanced safety writing skills across most safety document types.

• Highly collaborative with leadership abilities in cross-functional teams.

• Ability to independently manage multiple projects and deliver high-quality documents on schedule.

• Excellent English proficiency and advanced computer skills.

Why GSK:
GSK unites science, technology, and talent to get ahead of disease together, positively impacting global health while enabling employees to thrive. They focus on vaccines, specialty, and general medicines, with investment in core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology. GSK emphasizes an inclusive, collaborative, and growth-oriented work environment.