EU labeling scientistOvěřeno, že jde o reálnou pozici

Koho hledáme

• Required: 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.

Co budeš dělat

• 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

O pozici

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.