External Comms Associate Director

Location: Gaithersburg, MD — Onsite/Hybrid

Pay Rate: $76/hr. W2 | Duration: 12 Months | Shift: Day, 8:00 AM-4:00 PM or 9:00 AM-5:00 PM

About the Role

The Clinical Regulatory Writing Associate Director will lead clinical regulatory writing activities across complex pharmaceutical development programs. This role will author and strategically review complex clinical-regulatory documents, provide submission communication leadership, and ensure documents meet regulatory, technical, and quality standards.

Responsibilities

• Lead clinical regulatory writing activities across complex portfolios.
• Author and review complex clinical-regulatory and submission documents.
• Develop Clinical Submission Communication Strategies (cSCS).
• Lead internal and external medical writing teams and vendor writers.
• Interpret complex clinical data and translate findings into concise regulatory messaging.
• Support drug development programs from development through launch and lifecycle management.
• Drive regulatory writing quality, process improvements, and operational excellence.
• Provide strategic writing and communications leadership at the program level.

Requirements

• Master's degree in Life Sciences or an appropriate scientific discipline required. Ph.D. or other advanced scientific degree preferred.

Skills

• Significant clinical/medical writing experience within the pharmaceutical industry or CRO environment.
• Clinical regulatory writing and submission document experience.
• Expertise in clinical-regulatory document development and review.
• Strong understanding of drug development processes and lifecycle management.
• Knowledge of pharmaceutical regulatory requirements and submission standards.
• Experience developing clinical Submission Communication Strategies (cSCS).
• Experience interpreting complex clinical data for regulatory documents.
• Experience leading medical writing activities across clinical development programs.
• Experience managing internal, external, and vendor medical writers.
• Expertise in label-focused clinical-regulatory communications.

Preferred Skills

• Ph.D. in a scientific discipline.
• Experience supporting complex global pharmaceutical submissions.
• Experience establishing clinical regulatory writing standards and best practices.
• Experience leading strategic communication activities across multiple drug development programs.
• Experience driving clinical regulatory writing process optimization and operational excellence.