Associate Director, Medical Writing Job at Rapport Therapeutics, Boston, MA

  • Rapport Therapeutics
  • Boston, MA

Job Description

Rapport Therapeutics seeks an Associate Director of Medical Writing to lead clinical and regulatory documentation for its RAP-219 neuromedicine portfolio. The role involves developing protocols, study reports, and regulatory submissions while integrating AI-enabled tools and collaborating across functions to support program advancement.

Responsibilities

  • Lead writing and review of clinical protocols, study reports, and regulatory documents for RAP-219 program
  • Collaborate across medical, clinical, regulatory, and biostatistics teams to ensure document accuracy and alignment
  • Evaluate and implement AI tools and automation to improve document development and workflow efficiency
  • Provide strategic guidance on document structure, content, and timelines for health authority submissions
  • Contribute to modernization of medical writing processes, templates, and standards

Requirements

  • Extensive experience in clinical and regulatory medical writing
  • Demonstrated expertise in AI-enabled tools and emerging technologies
  • Strong knowledge of regulatory guidelines and medical writing standards
  • Proven ability to manage cross-functional stakeholder collaboration
  • Experience developing clinical protocols and regulatory submissions
  • Track record of implementing process improvements and automation solutions

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