Job Purpose
Manages all aspects of post-marketing regulatory commitment studies and related non-interventional or real-world evidence research projects, including planning, coordination, execution, outsourcing, vendor oversight, budget management, risk management, data interpretation, and report development, while ensuring compliance with company written standards, local legislation, licensing conditions, and applicable regulatory requirements.
Key Responsibilities
Lead regulatory commitment studies, ensuring full compliance with regulatory requirements throughout the study lifecycle, including planning, data collection, analysis, and clinical study report development.
Develop, review, and maintain key study documents (Protocol, SAP, CSR, and related documents) in accordance with scientific evidence, company SOPs, and applicable regulations.
Oversee end-to-end study execution and budget management, ensuring delivery within approved scope, timelines, quality standards, and budget.
Act as business owner for CROs and external vendors, providing oversight and risk management aligned with GSK’s Internal Control Framework, including contract management, resource planning, performance monitoring, issue escalation, and KPI oversight.
Lead strategic interactions and communications with regulatory authorities regarding regulatory conditions for new drug approvals and responses to regulatory inquiries or requests for supplementary data.
Collaborate proactively with cross-functional teams and external stakeholders to ensure successful study delivery and regulatory compliance.
Develop and execute publication strategies, resulting in the dissemination of study outcomes through peer-reviewed journals, scientific congresses, and medical conferences.
Author and co-author scientific publications and presentations to support evidence generation, regulatory commitments, and real-world evidence (RWE) communication.
Requirements
MS in science, pharmacy, epidemiology, biostatistics, nursing, medical science, or a related life-science discipline
2+ years of experience, post-marketing study, non-interventional studies (NIS), real-world evidence (RWE), epidemiology, or regulatory commitment engagement within the pharmaceutical industry
Advanced medical writing skills, including protocol development, clinical study reports (CSRs), regulatory documents, manuscripts, abstracts, and scientific presentations.
Experience in scientific publication activities, including manuscript development, abstract preparation, publication planning, and interactions with internal and external authors in alignment with ICMJE recommendations
*LI-GSK
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.
We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.
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