Job Summary
A clinical research company has an open position for a Remote Senior Regulatory Labeling Specialist.
Core Responsibilities Include:
- Ensuring the US labeling content meets current CCDS
- Ensuring that tracking of development and implementation activities are documented and maintained
- Ensuring risks are appropriately escalated to management
Position Requirements Include:
- May require approximately up to 10% travel
- Bachelor's degree (BS/BSc or BA)
- At least 5 years of pharmaceutical experience
- 2 years in labeling or a related aspect of pharmaceutical drug development
- Significant knowledge of FDA current regulation/guidance
- Excellent oral and written communication skills