Associate Director Clinical Writing

Job Summary

Leading clinical regulatory writing activities, the full-time Associate Director Clinical Writing will oversee the development of high-impact regulatory documents and manage internal and external writing teams while based in Gaithersburg, MD.

Key responsibilities

• Author and oversee the development of regulatory documents supporting global submissions and lifecycle management
• Develop and execute Clinical Submission Communication Strategies (cSCS) for regulatory submissions
• Manage document planning and ensure submission readiness across complex drug development programs

Required qualifications

• Master's Degree in Life Sciences, Pharmacy, Biomedical Sciences, Biotechnology, Medicine, or a related field
• Experience in clinical regulatory writing within pharmaceutical, biotechnology, or CRO environments
• Proven ability to author Clinical Study Reports (CSRs) and regulatory submission documentation
• Knowledge of ICH, GCP, FDA, EMA, and global regulatory guidelines
• Expertise in managing cross-functional authoring teams and external medical writing vendors