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 ofaccountability/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 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.
The Label Specialist will require a deep and technical understanding of clinical trials, business processes, and the label technologies associated with clinical supply.
Skills and Capabilities:
- Label creation:Proven experience in clinical trial label creation
- 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).
- Language: Excellent English, both verbal and written.
- 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 follow‑through.
- 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.
Date Posted
22-cze-2026
Closing Date
05-lip-2026
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
