The Pre-clinical Labelling and Translation Specialist role is designed to support the Global Pack Management (GPM) team by managing all translation-related activities for Clinical Trial labels for Medicines and Vaccines. This role is integral to ensuring the accuracy of translations, thereby facilitating the company's global operations and adherence to international regulations. The specialist is responsible for identifying required translations, initiating and managing translation requests, and liaising with external translation service providers to ensure timely and accurate translations. The role demands a high level of attention to detail, excellent organizational skills, and the ability to handle information with confidentiality. Additionally, the Pre-clinical Labelling and Translation Specialist oversees the export and import of files to and from GMP systems, coordinates with third-party translation providers, and manages the integration of completed translation files back into the system. This involves assessing translation needs for upcoming studies, creating and reviewing change controls for translations, and ensuring cross-departmental business requirements are met. The specialist is also accountable for executing a range of supporting pre-label creation activities, ensuring the accuracy and compliance of GMP Data within Global Pack Management, and provides support in aspects related to Clinical Trial pack and label approval. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Assess upcoming label requests for new English phrases and translations as needed. Ensure the quality of translated files, including proofreading and executing translation change controls for accuracy and consistency. Export and import files to and from GMP system. Utilize relevant computer packages, such as Excel, Word, Acrobat, xml and Adobe for managing and organizing data. Comply with appropriate Standard Operating Procedures to ensure accuracy for the GMP activities being conducted. Ensure translated documents comply with the regulations of the target country, understanding and applying the terminology and conventions used in the pharmaceutical industry. Manage translation projects, including coordinating with external translation agencies, managing timelines, and ensuring deliverables are met. Look for opportunities to develop and improve existing processes relating to translations. Collaborate closely with other teams such as Regulatory Affairs, Clinical Interface, and Global Pack Management to ensure the translated documents meet their needs. Act as the point of contact for all translation queries, providing guidance and support as needed. Responsible for archiving translations for future reference and compliance. Understand the process across the supply chain to ensure timely and accurate delivery of both information and documentation. Support processes and projects related to changes in regulations, required terminology, and best practices in the pharmaceutical industry. Adhere to all company and regulatory health and safety guidelines to ensure a safe working environment. Work within a global team, create master label content according to existing processes and procedures. Perform quality critical checks of externally produced vendor label proofs prior to receipt by GSK. Perform quality critical checks of label content produced in various languages within the required timelines. Own and implement corrective and preventive actions (CAPAs) Participate in GPM team meetings. Liaise with other groups within Clinical Supply Chain and Quality Assurance. Why you? Basic Qualifications: High School Diploma 3 years of previous experience in a GMP, manufacturing, pharmaceutical, regulatory, or label/translation environment. Experience working in Microsoft package and Adobe tools Knowledge of Good Manufacturing Practices (GMPs) preferential Preferred Qualifications: Experience working in GMP IT software systems Strong oral & written communication skills Able to follow written instructions, shows a good degree of accuracy and attention to detail. Demonstrates an understanding of clinical packaging and manufacturing terminology Able to manage own time and workload priorities, self-motivated and able to work as part of a team. Ability to identify problems as they occur and bring them to the attention of the Team Leader. Demonstrate ability to set and reach goals, high standards of performance and ability to resolve difficulties. Works effectively with others to meet timelines, business goals, and objectives. Ability to work across different departments to deliver desired outcomes to the wider business Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or 1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles.