Inna praca Warszawa

Opis oferty pracy

For our client we are looking for candidates for the position of Manager, eLabeling – Business Outcomes Delivery (ePI/ Digital Labeling) – M/K.ZAKRES OBOWIĄZKÓW:

- Support the rollout and adoption of structured eLabeling solutions (ePI, FHIR, IDMP)
- Drive continuous improvement of structured authoring platforms and digital labeling processes
- Collaborate with business, technical teams, and vendors to deliver scalable digital solutions
- Translate business and regulatory needs into clear, structured requirements and acceptance criteria
- Analyze workflows and identify opportunities for process optimization and standardization
- Support product roadmap execution and ensure alignment across global stakeholders
- Contribute to system adoption, change management, and continuous improvement initiatives
- Participate in global projects and support audit and inspection readiness
- Communicate with international stakeholders and explain complex topics in a clear and concise way

WYMAGANIA:

- Bachelor’s degree or equivalent experience
- 3-4+ years of experience in Regulatory Affairs, Regulatory Operations, Quality Systems, or similar
- Experience in labeling, regulatory submissions, Medical Information, or CMC
- Strong analytical skills with a process improvement mindset
- Ability to translate business needs into structured, testable requirements
- Experience working in cross-functional, international environments
- Strong communication and stakeholder management skills
- Fluent English
- Experience with eLabeling, structured authoring, or digital transformation initiatives
- Knowledge of FHIR, IDMP, or ePI standards
- Experience working with modern digital tools, including AI-based solutions
- Project management experience or certification

OFERUJEMY:

- Direct employment with a global pharmaceutical organization
- Hybrid work model (Poland-based)
- Opportunity to contribute to global digital transformation initiatives
- Work in an international, cross-functional environment
- Exposure to modern technologies used in regulatory processes
- Professional development within global structures
- Attractive benefits package (private healthcare, sports card, insurance)
- The offer applies to permanent work