Director, Clinical and Regulatory Strategic Communications

Merck seeks a Director of Clinical and Regulatory Strategic Communications to lead the design, authoring, and delivery of regulated clinical and public-facing documents across the development pipeline. The role provides scientific expertise, project leadership, and strategic oversight while ensuring compliance with regulatory requirements and health literacy principles.

Responsibilities

• Lead design, planning, and authoring of accurate, high-quality regulated documents across multiple programs
• Serve as escalation point for issues impacting timelines, quality, or compliance
• Identify and lead initiatives to improve medical writing processes, standards, and technology platforms
• Provide scientific mentorship and project oversight to medical writers and cross-functional teams
• Collaborate strategically with key stakeholders to ensure regulatory compliance and health literacy principles

Requirements

• Bachelor's degree or higher in health, scientific, or life sciences discipline
• 7+ years of medical writing or pharmaceutical industry experience
• Experience authoring clinical regulatory documents and public-facing materials per regulatory requirements
• Expert knowledge of drug development, clinical research processes, and ICH GCP guidance
• Demonstrated leadership across organizational levels with conflict resolution and negotiation skills
• Ability to analyze clinical data, manage complex projects, and drive innovation in medical writing processes