Principal Medical Writer

Job Purpose The Medical Writing Manager is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trials designs and interpretation of statistically analysed research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments including marketing application submission documents. This role has extensive clinical document expertise and will lead in the implementation of best practices and continuous improvement. He/she has the ability to plan and prioritise without supervision. Key Responsibilities Proven track record in writing a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, informed consent forms (ICF), clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents (BD), and responses to regulatory authority questions. Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements. Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide. Demonstrated effectiveness in management of projects of increasing scope and complexity. Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome). Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions. High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data. Assess trends and patterns in text and statistical data, and effectively organise content and messages in clinical reports and summary documents. Review reporting and analysis plans and provide critical input on the content and display of tables. Familiarity with approaches to expedite document preparation such as review tools and automation. Can mentor junior writers. Demonstrated ability and willingness to adjust behaviours and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas). Effectiveness in both oral and written communications. Education & Qualifications PhD or equivalent expertise (e.g., a master’s degree with relevant experience). Life sciences PhD is the minimum post graduate entry qualification required for this grade. The role will require a good understanding of complex regulatory writing processes including data interpretation & skills to communicate information to target audiences. The post graduate qualification should reflect experience of independently conducting scientific research, data interpretation and ability to write for a scientific audience. A PhD is the global industry standard for medical writers, and a significant number of the current Medical Writing department has PhDs. This reflects the experience of independently conducting scientific research, data interpretation and ability to write for a scientific audience. Professional Experience Preferably at least 5 years clinical regulatory writing experience in the pharmaceutical industry. Possesses a good understanding of drug development. Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research. Clear demonstration of understanding of how to interpret, describe and document clinical data. Possesses working knowledge of International Committee for Harmonisation (ICH)/Good Clinical Practice (GCP). Possesses necessary computer skills and general computer literacy. Excellent English language skills (verbal and written). Salary In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD116,000 to CAD166,000, determined based on experience, qualifications, and internal equity. Inclusion Statement As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process. Why GSK? Unite 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. #J-18808-Ljbffr