Clinical Development Medical Writer

Shape clinical development documents at MMS through rigorous literature analysis, regulatory writing, and interpretation of clinical data. Work with clients and multidisciplinary project teams.
This Principal Medical Writer authors and edits documents supporting clinical research and regulatory submissions. Assignments include protocols, investigator brochures, clinical study reports, consent forms, safety and efficacy summaries, and Module 2 documents. You will also prepare presentations and medical journal publications.

Key Responsibilities:

Analyze primary literature for study design and scientific rigor
Author clinical protocols as well as development documents
Produce interpretive guides and publication materials
Manage writing workflows and complete assignments promptly
Consult project teams and mentor writers as needed
Requirements:
Bachelor’s, master’s, or PhD scientific degree
Six years of previous regulatory writing experience
Substantial protocol experience as lead author
Exceptional writing and organizational skills
Understanding of federal regulations, Good Clinical Practices, and ICH guidelines
Use clinical development expertise, precise writing, and project coordination to deliver evidence-based documents for MMS clients.