Clinical Focus Regulatory Writer II

Job Summary

A company in the pharmaceutical industry is looking for a Clinical Focus Regulatory Writer II.

Position Responsibilities:

• Author documents per regulatory and client specifications
• Lead project-related meetings with minimal support
• Understand and adhere to constraints of budgets and tasks as provided by project leads

Required Qualifications:

• Bachelor's degree or higher, scientific discipline strongly preferred
• 1 to 3+ years of regulatory writing experience or equivalent experience
• Possess an understanding of the drug development process
• Possess technical regulatory knowledge to understand client technical requirements and needs
• Knowledge of a range of clinical documents such as, Clinical Study Reports, Investigator Brochures, protocols ISS and/or ISE