EU labeling scientistVerified as a real position

Who we’re looking for

• Bachelor’s degree in a scientific or medically related discipline. Preferred: Advanced degree (M.S., Pharm.D, Ph.D.).
• Minimum of 2 years of labeling experience or relevant regulated industry experience (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance, Medical Writing).
• Excellent writing and communication skills in English.
• Proficient project management skills with the ability to handle multiple tasks and prioritize effectively.
• Ability to perform well in ambiguous situations.
• Proactive and action-oriented approach.
• Attention to detail and focus on accuracy.
• Skills in influencing and negotiating.
• Ability to break down complex issues and propose solutions.

What you’ll do

• manage the EU Product Information (including all its Annexes as defined by EU legislation) for marketed products registered under EU procedures (MRP/DCP/CP).
• provide labeling expertise and guidance, including labeling precedence and competitor labeling, to teams while ensuring compliance with applicable regulatory requirements
• facilitate cross-functional teams comprised of senior level cross-functional stakeholders to develop, review and approve EU Labeling documents.
• collaborate with data owners and subject matter experts regarding scientific and medical information
• recommend strategies and labeling language for inclusion in EU Labeling during labeling development or responses to Health Authority.
• evaluate risks associated with EU Labeling content, developing mitigation strategies, and appropriately escalating issues to management and stakeholders

About the position

We invite you to join our mission of advancing the prevention and treatment of diseases. The purpose of Global Labeling is to drive labeling strategy and ensure high-quality and compliant labeling documents which, provide the safe and effective use of products for patients and healthcare providers globally.