Job Summary
A biopharmaceutical company has a current position open for a Remote Senior Global Labeling Lead Specialist.
Core Responsibilities of this position include:
- Operating as the primary point of contact on assigned products for all internal and external stakeholders
- Providing project management throughout the entire process
- Providing regulatory expertise and guidance for the development and submission of US labeling components
Qualifications for this position include:
- Bachelor's degree in a scientific or medically-related discipline required
- Regulatory submission experience
- Minimum of 4 years of pharmaceutical experience or relevant professional experience
- Process improvement and compliance/quality experience
- Labeling experience (CCDS, US, EU) in oncology or other relevant industry experience related to developing regulatory documentation
- Experience in Word, Excel and PowerPoint, and document management tools
