Associate Director, Medical Writing

Rapport Therapeutics•Boston, MA

18h•$185,000 - $205,000•Hybrid

About The Position

Rapport Therapeutics is seeking an experienced, AI-forward Associate Director, Medical Writing to serve as a medical writing lead for clinical programs within the RAP-219 portfolio. This role will lead the planning, development, and delivery of high-quality clinical and regulatory documents aligned with program goals, regulatory requirements, and modern medical writing practices. The successful candidate will bring strong regulatory writing expertise, sound judgment in the use of AI-enabled tools and emerging technologies, and the ability to partner effectively across functions to resolve feedback, foster alignment, and keep complex documents and submissions moving forward. This role reports directly to the Head of Medical Writing, ensuring alignment with departmental objectives and strategic direction.

Requirements

Minimum of 8+ years of relevant medical writing experience in the biopharmaceutical industry, with proven success leading the preparation of clinical and regulatory documentation.
Advanced degree in a scientific or health-related discipline preferred; equivalent combination of education and relevant regulatory medical writing experience may be considered.
Experience as a lead writer for late-phase clinical programs; CNS experience strongly preferred.
Thorough understanding of ICH, FDA, and EMA regulatory requirements for clinical and regulatory documents.
Demonstrated AI literacy and practical experience using, evaluating, or implementing AI-enabled tools, automation, structured content, content reuse, or other technologies to improve medical writing efficiency, consistency, and quality.
Strong judgment in the responsible use of AI, including the ability to validate AI-assisted outputs, identify risks and limitations, maintain data confidentiality, and ensure that final deliverables meet scientific, regulatory, and quality standards.
Excellent written and verbal communication skills, with strong attention to detail and the ability to manage multiple priorities.
Strong stakeholder management skills, including the ability to build trust with cross-functional partners, navigate ambiguity, manage competing priorities and perspectives, resolve disputes constructively, and foster alignment among diverse contributors.
Demonstrated leadership, project management, stakeholder management, and mentoring skills, with the ability to influence without authority and maintain momentum in complex, cross-functional document development processes.

Responsibilities

Lead the development, writing, and review of key clinical and regulatory documents for the RAP-219 program, including clinical study protocols, clinical study reports, Investigator’s Brochures, briefing documents, and Module 2 summaries.
Collaborate with medical science, clinical operations, regulatory, biostatistics, pharmacovigilance, and other functions to ensure accurate, consistent, and strategically aligned document content; manage stakeholder input, reconcile differing perspectives, and drive timely resolution of conflicting feedback.
Provide strategic input and guidance on document content, structure, and timelines to support regulatory submissions and global health authority interactions.
Maintain up-to-date knowledge of regulatory medical writing standards, relevant regulatory guidelines, and advances in AI, automation, structured content, and digital technologies affecting regulatory documentation.
Evaluate and support implementation of AI-enabled tools and automation solutions to improve document development, quality control, content reuse, and workflow efficiency; assess benefits and limitations and help establish standards for compliant adoption.
Contribute to the development, modernization, and implementation of medical writing processes, templates, standards, and tools, with a focus on scalable approaches that improve quality, consistency, and operational efficiency.