Manager, Global Labeling Operations

Role Overview

• Lead the implementation activities for labeling under the responsibility of Global Labeling Operations
• Provide Regulatory guidance on the development of U.S. packaging text for labeling mockups and production artwork
• Manage labeling implementation inputs and deliverables for registration sample packs, Software as a Medical Device (SaMD)
• Track implementation of artwork for safety changes and other types of labeling issued
• Complete or provide input into Change Controls related to labeling implementation or delisting activities

Requirements

• A minimum of a Bachelor’s degree is required, preferably in a scientific discipline
• A minimum of 4 years of relevant experience supporting labeling development, implementation, or operations is required
• Experience in the Pharmaceutical industry is preferred
• Knowledge of labeling processes and systems is required
• Experience with NDA or BLA launches preferred
• Must have excellent verbal and written communication skills

Benefits

• Health insurance
• 401(k) matching
• Paid time off (120 hours vacation, 40 hours sick time)
• 480 hours parental leave within one year of a child’s birth/adoption/foster care
• 240 hours bereavement leave for an immediate family member