Senior Director, Medical Writing - Remote

Overview

The Senior Director, Medical Writing will lead all medical writing activities across clinical development programs at Parabilis Medicines, ensuring quality and regulatory excellence in documentation.

In Short

• Lead medical writing strategy and execution for clinical programs.
• Authorship of key documents including clinical protocols and regulatory submissions.
• Collaborate with clinical and regulatory leaders on documentation plans.
• Oversee external writing vendors and ensure quality control.
• Develop medical writing templates and best practices.
• Ensure compliance with ICH and GCP guidelines.
• Mentor cross-functional authors on documentation strategies.
• Drive operational excellence within Clinical Operations.
• Contribute to scientific accuracy in clinical communications.
• Influence clinical execution and regulatory interactions.

Requirements

• Advanced degree in a scientific discipline (MS, PharmD, PhD, MD).
• 15+ years of medical writing experience in biotech/pharma.
• Expertise in clinical and regulatory documents.
• Experience with AI/ML techniques in document production.
• Strong understanding of global regulatory expectations.
• Experience in cross-functional fast-paced environments.
• Ability to manage vendors and documentation workflows.
• Experience with early-phase oncology programs.
• Familiarity with Health Authority interactions.
• Ability to build trusted relationships across functions.

Benefits

• Competitive salary range of $250,000–$300,000 per year.
• Annual target bonus and equity options.
• Comprehensive benefits package for employee well-being.
• Inclusive workplace culture valuing diversity.
• Opportunities for professional growth and development.
• Collaborative and innovative work environment.
• Focus on patient outcomes and scientific impact.
• Support for pioneering drug development efforts.
• Engagement in high-impact therapeutic modalities.
• Commitment to operational excellence and teamwork.