Global Labeling Operations Excellence Lead

EMD Serono, Inc.; Billerica (MA); On-site; USD 127,900 - 191,800; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

EMD Serono, Inc. in the United States is seeking a Global Labeling Excellence Lead to drive operational excellence across global labeling activities within Regulatory Quality Safety.

You will partner with process owners and cross-functional teams to improve documentation, track milestones, and ensure compliant, timely labeling submissions across markets. This onsite role is based in Billerica, MA with travel.

Qualifications

• Bachelor’s degree in science/health-related discipline; advanced degree preferred.
• Minimum 5 years of pharmaceutical industry or related experience.
• Strong project management with global, matrix, cross-cultural experience.
• Operational excellence mindset with process improvement experience.
• Ability to manage multiple priorities and maintain high-quality documentation.
• Digital fluency and willingness to adopt innovative ways of working.
• Experience in product labeling, regulatory affairs, quality, or related function.

Responsibilities

• Support development, maintenance, and review of global labeling documentation.
• Coordinate and track labeling updates, milestones, and stakeholder inputs.
• Develop and maintain global labeling project plans and health authority tracking.
• Establish and oversee a global labeling commitment tracker.
• Monitor labeling implementation across markets and track compliance metrics.
• Partner with cross-functional RQS stakeholders on quality documentation and timelines.
• Identify and implement process improvements and digital solutions to enhance efficiency.

Skills

Project management

Stakeholder management

Cross-functional collaboration

Operational excellence

Change management

Digital fluency

Analytical skills

Regulatory awareness

Education

Bachelor's degree

Advanced degree (PhD/MD/MS/PharmD)

Job description

EMD Serono, Inc. in the United States is seeking a Global Labeling Excellence Lead to drive operational excellence across global labeling activities within Regulatory Quality Safety.

You will partner with process owners and cross-functional teams to improve documentation, track milestones, and ensure compliant, timely labeling submissions across markets. This onsite role is based in Billerica, MA with travel.