Job Title: Label Specialist
Location: Macclesfield, UK
Introduction to the role:
The Global Clinical Supply Chain function is accountable for the supply of medicines to AstraZeneca’s clinical order todeliver medicine to patients in clinical trials the patient kits need to have translated and regulatory compliant label.
About the role:
The Label Specialist leads Label development projects/programmes. They have a working knowledge of project management methodologies, tools and templates and contribute to the development and maintenance of work products or change programmes. They ensure that business requirements are effectively captured andare responsible foreffective tracking and reporting of project management information, as well as highlighting and supporting the resolution of areas of risk in project delivery. 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.
Accountabilities:
Subject matterexpertise: 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 theappropriate clinicallabeling strategy is implemented.
Label development: Create labels and manageendtoendlabeling activities, including PBKL (product booklet labels) creation and coordination.
Process optimization:Identifycostsavingopportunities, assess timelines, and implementoptimalapproaches 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 byinitiatingand driving improvements and reviewing solution options.
External collaboration: Represent AstraZeneca within the broader Clinical Trial Sponsor community to collaborate on implementingnew technologiesin labeling (including external networks).
Capability building: Delivertrainingsand act as a mentor/buddy for team members and new joiners.
Team engagement: Lead and contribute to team meetings; ensure effective stakeholder and vendor collaboration andtimelyescalation of risks/issues related to systems and activities viaappropriate channels.
Documentation: Develop and contribute to key documents related to label creation.
Essential Skills & Experience:
Label creation:Proven experience in clinical trial label creation role
Regulatory requirements:Proven experience in interpreting and applying global (country-specific) regulatory requirements, including label creation and documentation for clinical trial submissions.
Computing skills: Strongproficiencywith relevant software/tools (, labeling systems, document management, project tracking).
Communication: Clear, concise communication with diverse stakeholders and vendors.
Stakeholder and vendor management: Effectivecross functionaland external partner engagement.
Time and task management: Strong organization, prioritization, andfollowthrough.
Analytical and strategic thinking (clinical trial labels):Proven ability to analyze label-related data (, regulatory requirements, country-specific translations, packaging constraints, stability/expiry rules, and change history) and shape labeling strategy that optimizes compliance, speed, and cost—prioritizing markets, standardizing text where possible, and aligning updates with protocol amendments and supply timelines.
Attention to detail:High levelof accuracy and quality in documentation and outputs.
Learning agility: Ability to absorbnew informationand systems quickly.
Change management:Proven experience ininterpretingandtimelyimplementation CAPA/deviation records and regulatory submissions whererequired.
Customer focus & flexibility: Adaptable to diverse customer needs and timelines.
GxPknowledge:Proven working knowledge and practical application ofGxP(, GMP, GCP, GDP) in a clinical trial environment.
The Label Specialist willrequirea deep and technical understanding of clinical trials, business processes, and the label technologies associated with clinical supply. Further key capabilitiesrequiredfor this role include Change enablement, Flexibility/adaptability and working collaboratively. This role willimpactthe speed, quality, cost, and risk profile of development projects, affecting the availability of study drugs to patients.
Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
Are you already imaging yourself joining our team? Feel free to submit your application by June 29th.
Date Posted
15-Jun-2026Closing Date
28-Jun-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.