EU labeling scientist Full-time

Job Title

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.

As part of Labeling Strategy function in Global Labeling, you will be accountable for developing labeling content and maintaining the target product labeling for developmental products, Core Labeling documents (e.g., CCDS, CCPPI, CCIFU), US Labeling, and EU Labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of other country's Local Labeling.

The Scientist, EU Labeling is responsible for:

• 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

Education

• Required: Bachelor's degree in a scientific or medically related discipline.
• Preferred: Advanced degree (M.S., Pharm.D, Ph.D.).

Required Experience & Skills:

• 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.

Required Skills:

Data Quality Assurance, Detail-Oriented, Medical Writing, Pharmaceutical Regulatory Affairs, Policy Implementation, Project Management, Regulatory Communications, Regulatory Labeling

Preferred Skills: