Job Summary
A clinical research organization is seeking a Remote Senior Medical Writer.
Core Responsibilities of this position include:
- Developing timelines and resource plans for the production of clinical study reports and filings
- Preparing documents necessary for all phases of clinical drug development by organizing, analyzing, and interpreting scientific and statistical data
- Reviewing statistical analysis plans, summary table shells, and case report forms
Must meet the following requirements for consideration:
- Excellent writing (e.g., English usage) and a keen attention to detail are required
- BS/BSc/BA in a science or industry-related discipline
- Minimum of 5 years of medical writing experience in a contract research organization (CRO), pharmaceutical, or biotech setting
- Working knowledge of ICH and other regulatory guidelines
- Fluency in English (spoken and written) is required
- Proficiency in Microsoft Word and graphic presentations is required
