PMS Specialist - Post-Marketing Studies

About the role

GSK is looking for a PMS Specialist to manage post-marketing regulatory commitment studies and related non-interventional or real-world evidence research projects. The role covers planning, coordination, execution, outsourcing, vendor oversight, budget and risk management, data interpretation and report development, in line with company standards, local legislation, licensing conditions and regulatory requirements.

Key responsibilities

• Lead regulatory commitment studies from planning and data collection through analysis and clinical study report development, ensuring full compliance with regulatory requirements.
• Develop, review and maintain protocols, statistical analysis plans, clinical study reports and related documents according to scientific evidence, company SOPs and regulations.
• Oversee end-to-end study execution and budget, keeping delivery within scope, timelines, quality standards and budget.
• Act as business owner for CROs and external vendors, managing contracts, resources, performance, issues and KPIs under GSK's Internal Control Framework.
• Engage with regulatory authorities on approval conditions and respond to regulatory inquiries and requests for supplementary data.
• Work with cross-functional teams and external stakeholders to ensure successful study delivery and compliance.
• Develop publication strategies and author or co-author scientific publications and presentations to share study outcomes.

Required profile

• Master's degree in science, pharmacy, epidemiology, biostatistics, nursing, medical science or a related life science.
• 2+ years of experience in post-marketing studies, non-interventional studies, real-world evidence, epidemiology or regulatory commitment work in the pharmaceutical industry.

Required skills

• Advanced medical writing: protocols, clinical study reports, regulatory documents, manuscripts, abstracts and presentations.
• Scientific publication experience, including manuscript development and publication planning in line with ICMJE recommendations.