LabelSpecialist

Location: Warsaw, Poland Hybrid model of work: 3 days in office, 2 remote per week Type of contract: 12 months fix term **Label Specialist** leads Label development projects/programmes. The individual has a working knowledge of project management methodologies, tools and templates and contributes to the development and maintenance of work products or change programmes. They ensure that business requirements are effectively captured and are responsible for effective tracking and reporting of project management information, as well as highlighting and supporting the resolution of areas of risk in project delivery. The Global Clinical Supply Chain function is accountable for the supply of medicines to AstraZeneca’s clinical trials. In order to deliver medicine to patients in clinical trials the patient kits need to have translated and regulatory compliant label. Label development is business-critical and linked to the overall delivery and approval of clinical trials. Frequently, label development activities are on the business-critical path for study set-up and start. There are key areas of **accountability/responsibility** : * **Subject matter expertise** : Serve as an SME within the Global Clinical Supply Chain; provide support for label changes during study maintenance. * **Study strategy input** : Contribute to study setup/design strategy discussions to ensure the appropriate clinical labeling strategy is implemented. * **Label development** : Create labels and manage end‑to‑end labeling activities, including PBKL (product booklet labels) creation and coordination. * **Process optimization** : Identify cost‑saving opportunities, assess timelines, and implement optimal approaches across current label development processes. * **Continuous improvement** : Enhance labeling processes and documentation (SOPs, WIs, GUIs, and training materials) and drive standardization. * **Systems and tools** : Support system upgrades by initiating and driving improvements and reviewing