External Comms Associate Director

Job Title: Associate Director – Clinical Regulatory Writing
Location: Gaithersburg, MD
Pay Rate: $76.00/hr
Duration: 12 Months

Job Description

• Lead clinical regulatory writing activities across complex drug development programs and submission portfolios.
• Author and oversee development of high-impact clinical-regulatory documents supporting global regulatory submissions and lifecycle management activities.
• Develop and execute Clinical Submission Communication Strategies (cSCS) for regulatory submissions.
• Interpret complex clinical, scientific, and regulatory data and translate findings into submission-ready regulatory documents.
• Establish document messaging, content strategy, quality standards, and regulatory compliance requirements across programs.
• Lead document planning, authoring, review cycles, and submission readiness activities.
• Manage internal and external medical writing teams, including CRO/vendor medical writers, to ensure delivery of high-quality regulatory documentation.
• Drive communication excellence, operational efficiency, and regulatory writing best practices across development programs.
• Provide strategic regulatory writing leadership for cross-functional clinical development and submission teams.
• Mentor and support development of regulatory writing professionals and contribute to process improvement initiatives.

Education

• Master’s Degree in Life Sciences, Pharmacy, Biomedical Sciences, Biotechnology, Medicine, or related scientific discipline required.
• Ph.D. or other advanced scientific degree preferred.

Required Skills

• Clinical regulatory writing within pharmaceutical, biotechnology, or CRO environments.
• Authoring of Clinical Study Reports (CSRs), Clinical Summaries, Clinical Overviews, regulatory submission dossiers, and submission-related documentation.
• Global regulatory submission support for IND, NDA, BLA, MAA, and lifecycle management activities.
• Clinical Submission Communication Strategy (cSCS) development and execution.
• Regulatory document planning, content strategy, quality review, and submission readiness management.
• Interpretation and presentation of clinical trial data, efficacy results, safety data, and integrated analyses.
• ICH, GCP, FDA, EMA, and global regulatory guidance knowledge.
• Drug development lifecycle expertise spanning clinical development through registration and post-approval activities.
• Regulatory writing quality standards, document governance, and compliance management.
• Leadership of cross-functional authoring teams and external medical writing vendors.
• Strategic review of scientific and clinical documentation to ensure regulatory alignment and submission quality.

Preferred Skills

• Experience leading regulatory writing activities for complex global submissions and major regulatory milestones.
• Therapeutic area expertise across multiple clinical development programs.
• Submission publishing and electronic regulatory submission processes.
• Process improvement, regulatory operations, and document management system experience.
• Regulatory intelligence and global health authority interaction support.
• Mentoring and leadership experience within Clinical Regulatory Writing organizations.