Associate Director, Medical Writing

When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we’re driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we’re doing this with extraordinary science and awesome people (affectionately called Rapptors).

Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials in primary generalized tonic-clonic seizures (PGTCS) and bipolar disorder.

The strength of Rapport comes from our Rapptors – who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you’re as excited about this opportunity as we are!

We anticipate hiring for this role in mid-Q4. This role is located in Boston, MA with an onsite requirement of Monday-Wednesday every week.

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.

• 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.

• 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…