Label Specialist (12 months Fix term)
HybridWarsaw, Mazovia, Poland
Warsaw, Mazovia, PolandHybridFull TimeSenior LevelSmall
Full TimeSenior LevelSmall
Job Summary
Lead label development projects and programmes, creating labels and managing end-to-end labeling activities including PBKL creation. Capture business requirements, track project information, and highlight risks for resolution within the Global Clinical Supply Chain. Contribute to study setup strategy, optimize processes for cost savings, and enhance documentation standards. Represent AstraZeneca externally to collaborate on new labeling technologies and deliver trainings for team members. This 12-month fix term role involves a hybrid schedule of three office days and two remote days in Warsaw, Poland.
Required Qualifications
- Proven experience in clinical trial label creation
- Proven experience in interpreting and applying global (country-specific) regulatory requirements, including label creation and documentation for clinical trial submissions
- Strong proficiency with relevant software/tools (e.g., labeling systems, document management, project tracking)
- Excellent English, both verbal and written
- Clear, concise communication with diverse stakeholders and vendors
- Effective cross-functional and external partner engagement
- Strong organization, prioritization, and follow-through
- 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
- High level of accuracy and quality in documentation and outputs
- Ability to absorb new information and systems quickly
- Proven experience in interpreting and timely implementation CAPA/deviation records and regulatory submissions where required
- Proven working knowledge and practical application of GxP (e.g., GMP, GCP, GDP) in a clinical trial environment
- 3 days in office, 2 remote per week
- Deep and technical understanding of clinical trials, business processes, and the label technologies associated with clinical supply
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.