Director Medical Writing

Enigma Search; United States; On-site; USD 180,000 - 230,000; Full time

Job summary

Enigma Search is seeking a Director of Medical Writing to lead the development of regulatory and clinical documents across development programs. You will translate complex data into submission-ready content and partner with Regulatory, Clinical, Biostatistics, Safety, and Quality teams.

The role emphasizes strategic leadership, process improvement, vendor management, and the use of structured content and AI-enabled tools to enhance efficiency and quality of manuscripts.

Qualifications

• 8 years of medical writing experience in biopharma.
• Experience authoring clinical and regulatory documents across drug development.
• Knowledge of FDA, ICH, EMA global requirements.
• Vendor leadership and cross-disciplinary collaboration.

Responsibilities

• Lead medical writing function for clinical and regulatory documents.
• Ensure documents meet regulatory standards.
• Manage external vendors and partners.
• Collaborate across teams to support submissions.
• Improve writing processes and standards.
• Explore AI-enabled tools to improve efficiency.

Skills

Medical Writing

Regulatory Writing

Leadership

Cross-functional Collaboration

AI-enabled writing tools

Tools

Document Automation

AI-enabled writing tools

Job description

About the job Director Medical Writing

We're seeking an experienced Director of Medical Writing to lead the development of high-quality clinical and regulatory documents across our development programs. This role is ideal for a strategic leader who can translate complex scientific and clinical data into clear, accurate, and submission-ready regulatory content.

Reporting to the VP of Regulatory & Quality Science, you'll partner with cross-functional teams including Regulatory Affairs, Clinical Development, Biostatistics, Clinical Operations, Safety, Quality, and CMC to drive key regulatory deliverables and support program advancement.

Key Responsibilities

• Lead the medical writing function and oversee clinical and regulatory document development, including protocols, clinical study reports, health authority meeting materials, and submission content.
• Ensure documents are scientifically accurate, strategically aligned, and meet global regulatory standards.
• Manage external medical writing vendors and partners to deliver high-quality, timely results.
• Collaborate cross-functionally to support regulatory submissions and development milestones.
• Establish and improve writing processes, templates, and standards.
• Identify opportunities to leverage structured content, automation, and AI-enabled tools to improve efficiency and quality.

Qualifications

• 8 years of medical writing experience in the biopharmaceutical industry.
• Strong experience authoring and managing clinical and regulatory documents across the drug development lifecycle.
• Knowledge of FDA, ICH, EMA, and global regulatory requirements.
• Experience interpreting clinical data and working with protocols, SAPs, TFLs, safety, and efficacy outputs.
• Proven ability to lead vendors and collaborate effectively across multidisciplinary teams.
• Experience with document automation, structured content, or AI-enabled writing tools is a plus.

What You’ll Bring

• Strong leadership, communication, and collaboration skills.
• A strategic mindset with a hands-on approach.
• A passion for advancing innovative therapies and delivering high-quality regulatory documentation.