Macclesfield, England, United Kingdom · On-site
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 trials. In order to deliver …
Skills: Clinical Trial Label Creation, Regulatory Compliance, Project Management, GxP Knowledge, Stakeholder Management
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Frederick, Maryland, United States · On-site
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Warsaw, Masovian Voivodeship, Poland · On-site
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Taiwan · On-site
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Taiwan · On-site
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China · On-site
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Taiwan · On-site
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Dublin, Leinster, Ireland · On-site
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Beijing, Beijing, China · On-site
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Sofia, Sofia-City, Bulgaria · On-site
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Warsaw, Masovian Voivodeship, Poland · Hybrid
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Athens, Attica, Greece · On-site
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Beijing, Beijing, China · On-site
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Barcelona, Catalonia, Spain · Hybrid
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Petaling Jaya, Selangor, Malaysia · On-site
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China · On-site
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Bucharest, Romania · On-site
Key Account Manager CVRM – Timisoara AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of …
Skills: Stakeholder Engagement, Strategic Planning, Clinical Demand Generation, Scientific Communication, Account Management
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The Label Specialist leads the development of regulatory-compliant labels for clinical trial medicines, managing the end-to-end process from creation to coordination. They are responsible for optimizing labeling processes, maintaining documentation, and collaborating with stakeholders to ensure timely study set-up.
Candidates must have proven experience in clinical trial label creation and a deep understanding of global regulatory requirements and GxP standards. Proficiency in labeling software and strong analytical skills to shape labeling strategies are essential.
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.
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 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. 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 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 endtoend labeling activities, including PBKL (product booklet labels) creation and coordination.
Process optimization: Identify costsaving 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 solution options.
External collaboration: Represent AstraZeneca within the broader Clinical Trial Sponsor community to collaborate on implementing new technologies in labeling (including external networks).
Capability building: Deliver trainings and 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 and timely escalation of risks/issues related to systems and activities via appropriate 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: Strong proficiency with relevant software/tools (e.g., labeling systems, document management, project tracking).
Communication: Clear, concise communication with diverse stakeholders and vendors.
Stakeholder and vendor management: Effective cross functional and external partner engagement.
Time and task management: Strong organization, prioritization, and followthrough.
Analytical and strategic thinking (clinical trial labels): Proven ability to analyze label-related data (e.g., 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 level of accuracy and quality in documentation and outputs.
Learning agility: Ability to absorb new information and systems quickly.
Change management: Proven experience in interpreting and timely implementation CAPA/deviation records and regulatory submissions where required.
Customer focus & flexibility: Adaptable to diverse customer needs and timelines.
GxP knowledge: Proven working knowledge and practical application of GxP (e.g., GMP, GCP, GDP) in a clinical trial environment.
The Label Specialist will require a deep and technical understanding of clinical trials, business processes, and the label technologies associated with clinical supply. Further key capabilities required for this role include Change enablement, Flexibility/adaptability and working collaboratively. This role will impact the speed, quality, cost, and risk profile of development projects, affecting the availability of study drugs to patients.
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.
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
