Associate Director, Global Labeling Strategy Lead

 

Work Your Magic with us! Start your next chapter and join EMD Serono.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 

Your Role:

The Associate Director of Global Labeling / Labeling Product Lead (LPL) ensures globally harmonized product labeling in close collaboration with cross-functional labeling product teams by leading the creation and maintenance of Company Core Data Sheets (CCDS), regional labeling documents including US/EU product information (PIs), and global packaging text in compliance with regulatory standards. The LPL supports country regulatory affairs (CRA) in creating national product information (NPI) ensuring consistency with the CCDS or a reference label. The LPL is  the subject matter expert on labeling-related health authority queries and may also develop target product labeling content for development products.

 

Location: This is a hybrid, 3x/week in office position based in Billerica, MA

 

Key Accountabilities:

• Create and maintain global CCDS in collaboration with product teams to serve as the basis for worldwide harmonized labeling. In some cases, maintain RSI to represent company position.
• Manage the creation and maintenance, review and approval of US and EU PIs ensuring consistency with the CCDS.
• Lead cross-functional labeling team, prepare for and present proposals to the Labeling Senior Management Board, and secure internal approval of labeling content.
• Oversee and support implementation of CCDS content into local PIs.
• Coordinate and respond to labeling inquiries from health authorities and participate in regulatory negotiations.
• Lead the development of target product labeling content for development products, as needed.
• Provide competitive labeling analyses and maintain up-to-date knowledge of local and regional labeling requirements.
• Develop/contribute to labeling-related process documents and guidelines, propose company comments on regulatory initiatives, and drive cross-functional labeling initiatives.
• Train product labeling teams on labeling processes, guide other labeling experts on life-cycle management, and cultivate relationships with regulatory professionals, associations, and authorities.

 

 

Minimum Qualifications

• Bachelor’s degree in science or health-related discipline
• 5+ years of relevant pharmaceutical industry experience with 3+ years of relevant Regulatory Affairs Labeling experience
• Deep knowledge and application of labeling requirements in the US/EU

 

Preferred Qualifications

• Advanced degree (PhD, MD, MS, PharmD, MBA)
• Advanced proficiency with MS Office (Word, Excel, PowerPoint, Project), SharePoint and regulatory systems (e.g., EDMS)
• Meticulous in reviewing regulatory documents for accuracy, consistency, and compliance
• Excellent written and oral communication skills
• Knowledge and application of labeling requirements in global countries including Japan and China
• Knowledge of global drug‐development and life‐cycle management regulations

 

Pay Range for this position: $134,200 - 202,200
The offer range represents t