Clinical Regulatory Writing Associate Director

Location: Remote
Pay Rate: $76/hr
Duration: 12 Months

Job Description

The Clinical Regulatory Writing Associate Director will lead clinical regulatory writing activities across a complex portfolio of pharmaceutical drug development programs. This role focuses on authoring complex, label-focused clinical-regulatory documents, interpreting clinical data, and driving strategic communications aligned with regulatory requirements, submission strategies, and quality standards.

Responsibilities:

• Independently manage clinical regulatory writing activities across multiple drug development programs.
• Author complex clinical-regulatory documents in compliance with regulatory, technical, and quality standards.
• Lead strategic communications for clinical development and regulatory submission teams.
• Develop the clinical Submission Communication Strategy (cSCS) when acting as submission lead.
• Lead internal and external authoring teams and oversee vendor medical writing deliverables.
• Interpret complex clinical data and translate findings into clear, accurate, label-focused messages.
• Conduct strategic reviews of clinical-regulatory documents and drive continuous improvement in writing processes.
• Support the development of Clinical Regulatory Writing Managers.

Education

• Master’s degree in Life Sciences or an appropriate scientific discipline required.
• Ph.D. in a scientific discipline preferred.

Required Skills

• Significant medical writing experience in the pharmaceutical industry or CRO.
• Clinical regulatory writing and complex regulatory document authoring.
• Drug development knowledge across clinical development, launch, and lifecycle management.
• Clinical data interpretation and label-focused regulatory communications.
• Clinical Submission Communication Strategy (cSCS) development.
• Regulatory, technical, and quality requirements for clinical-regulatory documentation.
• Clinical regulatory submission support and strategic document review.
• Vendor medical writing oversight and authoring team leadership.

Preferred Skills

• Ph.D. in a scientific discipline.
• Experience supporting complex clinical development programs across multiple therapeutic areas.
• Experience driving clinical regulatory writing process improvements and operational excellence.