Principal Medical Writer

4w1 month ago

GSK

Stevenage, GB · Full-time · C$118,000 – C$168,000

About this role

We are seeking an experienced professional with advanced medical writing expertise who can independently manage complex regulatory writing projects. This role demands a deep understanding of clinical trial designs, statistical analysis interpretation, and clinical document processes.

In this role you will author and deliver high-quality clinical regulatory documents, including protocols, Clinical Study Reports, Investigator's Brochures, and CTD submission documents. You will lead the planning and development of clinical dossier documents for global regulatory submissions, ensuring quality, consistency, and timeliness.

You will partner within cross-functional, matrix teams to produce fit-for-purpose documents that accurately reflect clinical and statistical data. You will manage complex writing projects, coordinating multiple contributors and adapting plans to address evolving priorities, therapeutic areas, and submission needs.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We embrace modern work practices through our Performance with Choice programme, offering a hybrid working model that empowers you to find the optimal balance between remote and in-office work.

Requirements

PhD or equivalent relevant experience within the life sciences.
Advanced experience in clinical regulatory medical writing within the pharmaceutical industry.
Demonstrated ability to independently author complex regulatory documents and lead or significantly contribute to CTD submission dossiers, including Module 2 documents.
Strong understanding of clinical trial design, regulatory requirements, statistical concepts, and interpretation of clinical data.
Proven leadership capability with experience influencing and collaborating effectively in global, multicultural, and matrixed environments.
Working knowledge of ICH guidelines, Good Clinical Practice (GCP), and strong written and verbal English communication skills.

Responsibilities

Author and deliver high-quality clinical regulatory documents, including protocols, Clinical Study Reports (CSRs), Investigator's Brochures, briefing documents, CTD submission documents, and responses to regulatory authority questions.
Lead and contribute to the planning, development, and delivery of clinical dossier documents for global regulatory submissions, ensuring quality, consistency, and timeliness.
Partner within cross-functional, matrix teams to produce fit-for-purpose documents that accurately reflect clinical and statistical data and comply with GSK standards and regulatory requirements.
Manage complex writing projects, coordinating multiple contributors and adapting plans to address evolving priorities, therapeutic areas, and submission needs.
Interpret complex clinical and statistical information, identify key trends and messages, and translate data into clear, well-structured regulatory narratives.
Review reporting and analysis plans, provide critical input on tables and data presentation, and apply efficient document development approaches, including review tools and automation.