ClinicalOperationsSubmissionsSpecialist

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 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](https://www.gsk.com/en-gb/innovation/) _**Clinical Operations Submissions Specialist**_ Leads the co-ordination and delivery of specialized operational activities according to ICH GCP, international and local regulations, and relevant GSK written standards. The Clinical Operations Specialist plays a pivotal role as a member of the local clinical study team and is responsible for contributing to the planning, execution, and delivery of the Clinical trial in the country. This role will provide YOU the opportunity to lead key activities to progress YOUR career. **These responsibilities include some of the following:** * Responsible for determining the most appropriate submissions strategy for the study in collaboration with study team. Provides consult to the study team to ensure best possible outcome for regulatory and/or ethics committee submissions. * Accountable for the timely delivery of local regulatory and/or ethics submission content in collaboration with local and central study teams and global/local regulatory team if applicable * Responsible for the preparation, collation, review, tracking and filing of all documentation required for regulatory and/or ethics committee submissions. This may include Informed Consent form review, coordinating translations, preparation of central/national ethics