Job Summary

A health science company is seeking a Telecommuting Senior Medical Writer.

Candidates will be responsible for the following:

• Leading a single team which guides medical writing activities within a designated therapeutic or functional area
• Leading the writing strategy providing expertise including organization, content, timelines, and resource requirements
• Providing more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications

Qualifications for this position include:

• Bachelor's degree in science, health profession, or journalism required
• At least 5 years experience writing for pharma or biotechnology required. 3+ years of electronic documents and submissions required
• Experience as lead writer for key documents included in major US and/or international regulatory submissions required
• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status