Job Summary

A staffing and recruiting agency is in need of a Remote Regulatory Writing Specialist.

Must be able to:

• Establish document key messages, timelines, and priorities
• Plan, write, edit, and review regulatory documents
• Provides guidance to project team members

Qualifications Include:

• Minimum of a Bachelor’s degree
• Regulatory or medical writing experience in the pharmaceutical/biotechnology/medical device industry
• Minimum of 7 years of drug/biologics/device development experience
• Minimum of 5 years’ experience in the development of regulatory documents for Health Authority submission
• Experience in assembling scientifically complex data or information
• Easily adapts to changing priorities; able to propose solutions to complex problems