EU labeling scientist
Core
Develop and maintain compliant EU Product Information and target product labeling for pharmaceutical products to ensure safe and effective use for patients and healthcare providers globally.
Role type
EU Labeling Scientist
Builds
EU Labeling documents (CCDS, CCPPI, CCIFU) and Product Information for marketed products
Domain
Pharmaceutical Regulatory Affairs / Medical Writing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical Writing, Pharmaceutical Regulatory Affairs, Policy Implementation, Project Management, Regulatory Communications, Regulatory Labeling, Data Quality Assurance, Detail-Oriented
Preferred skills
Advanced degree (M.S., Pharm.D, Ph.D.), Experience in Medical Affairs, Clinical, Pharmacovigilance, or Medical Writing
Technologies
None stated
Responsibilities
Manage EU Product Information including all Annexes for products registered under EU procedures; Provide labeling expertise and guidance on precedence and competitor labeling; Facilitate cross-functional teams to develop, review, and approve EU Labeling documents; Collaborate with data owners and subject matter experts on scientific and medical information; Recommend strategies and labeling language for inclusion in EU Labeling; Evaluate risks associated with EU Labeling content and develop mitigation strategies
Seniority
Mid-level, hands-on IC
