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 cuttingedge technology to transform peoples 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. Were uniting science, technology, and talent to get ahead of disease together. Position Summary The Senior Medical Writer is expected to work on assignments largely independently or for complex documents, under guidance of a mentor, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content. The senior medical writer understands clinical trials design and interpretation of statistically analysed clinical research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments and should be able to meet the quality standards of the global organization. The Senior Medical Writer is responsible for the final deliverable and is expected to work in complex matrix organizations. Responsibilities Completes assignments independently or for more complex documents, under guidance of a mentor Authors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions. Ensures high integrity of data interpretation, following negotiation with document team. Ensures the consistency and quality level of all documents that are issued. Actively participates in all planning, coordination and review meetings. Ability to work on 23 assignments simultaneously. Proactively raises and discusses concerns/issues in an open and timely manner and within the global team, thereby demonstrating the ability of promoting high medical writing standards by pointing out obvious flaws and proposing (and advocating) alternatives. Works directly with a diversity of roles at different levels within GSK (e.g., Clinical Leads, Asset Leads, Study Delivery Leads (SDL), Biostatisticians, other Medical Writers). Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments. Basic Qualifications Up to 5 years in clinical and regulatory writing experience in the pharmaceutical industry Masters degree or higher in life sciences, pharmacy, medicine or a related scientific discipline. Demonstrated experience in preparing clinical regulatory documents (CSRs, clinical summaries and overviews). Good understanding of clinical trial design, data analysis and interpretation of safety and efficacy results. Strong written and verbal English communication skills. Comfortable working in a complex matrix environment and managing multiple priorities. Preferred Qualifications Possesses a good understanding of basic drug development Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research. Demonstrates understanding of how to interpret, describe and document clinical data. Possesses working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP). Working Model This role is hybrid, based in India. You will spend core days in the office to collaborate with colleagues and use flexible remote working for focused writing. 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 CAD 103,000 to CAD 153,000, determined based on experience, qualifications, and internal equity. Inclusion at GSK As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at to discuss your needs. #J-18808-Ljbffr
Job Title
Senior Medical Writer