The Clinical Regulatory Writing Associate Director will lead clinical regulatory writing activities across complex pharmaceutical development programs. The Fountain Group is currently seeking a External Comms Associate Director/Clinical Regulatory Writing Associate Director for a prominent client of ours.

The Fountain Group is currently seeking a External Comms Associate Director/Clinical Regulatory Writing Associate Director for a prominent client of ours. This position is located in Gaithersburg, MD.  Details for the position are as follows:

External Comms Associate Director/Clinical Regulatory Writing Associate Director

Location: Gaithersburg, MD — Onsite/Hybrid as applicable
Pay Rate: $76/hr. W2
Duration: 12 Months
Shift: Day, 8:00 AM–4:00 PM or 9:00 AM–5:00 PM
Interview Process: 30-minute Teams interview followed by a 2-hour Teams panel interview

Job Description

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.

• 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.

Education

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

Required 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.

By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy

#LI-BS1