Senior Medical Writer

Job description

Business IntroductionAt 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 cutting-edge technology to transform people’s 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. We’re uniting science, technology, and talent to get ahead of disease together.Find out more:Our approach to R&D  Position Summary The Senior Medical Writer is responsible for independently developing high-quality clinical and regulatory documents, seeking guidance from mentor for complex assignments as appropriate. The role requires strong knowledge of clinical trial design, interpretation of statistically analysed clinical research data, and effective coordination across global stakeholders to ensure timely, accurate, and compliant deliverables within a complex matrix organization. Key Responsibilities • Prepare a range of clinical and regulatory documents using defined templates, including protocols, clinical study reports, IND/NDA/MAA CTD  and IMPD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions. • Complete assignments independently, seeking mentor guidance as appropriate for complex documents. • Ensure accurate, consistent, and high-integrity interpretation of clinical data in collaboration with the document team. • Maintain consistent quality standards across all documents. • Participate actively in planning, coordination, and review meetings to support timely document delivery. • Manage two to three assignments simultaneously while maintaining quality and timelines. • Identify and discuss concerns in a timely and constructive manner within the global team, and also recommend alternatives to uphold high medical writing standards. • Work and collaborate effectively with cross-functional stakeholders within GSK, including Clinical Leads, Asset Leads, Study Delivery Leads, Biostatisticians, and other Medical Writers. • Build and maintain effective communication networks to support collaboration and smooth delivery of writing assignments.   Preferred Qualifications • PhD or equivalent expertise, such as a master’s degree with at least 2 years of relevant experience. • Up to 5 years of clinical regulatory writing experience in the pharmaceutical industry. • Good understanding of drug development, scientific methodology, and statistical principles in clinical research. • Ability to interpret, describe, and document clinical data accurately. • Working knowledge of ICH/GCP requirements. • Strong computer literacy and excellent written and verbal English skills. How to applyIf you are ready to make an impact through clear scientific communication, we would love to hear from you. Please submit your CV and a short cover note explaining your interest and relevant experience. Apply now and help us get ahead of disease together. Skills     Why GSK? Uniting 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. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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 IN.recruitment-adjustments@gsk.com to discuss your needs. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obta