Associate Director, Medical Writing - Lead Regulatory Docs

Rhythm Pharmaceuticals Inc.; Boston (MA); Hybrid; USD 160,000 - 240,000; Full time

Job summary

Rhythm Pharmaceuticals Inc. in Boston is seeking an experienced Associate Director of Medical Writing to independently author and oversee clinical, regulatory, medical, and safety documents across the development lifecycle.

You will partner with cross-functional stakeholders to advance Rhythm’s mission of delivering precision medicines to patients with rare neuroendocrine diseases. The ideal candidate brings strong scientific judgment and regulatory writing expertise, plus the ability to lead

Qualifications

• Bachelor’s degree required; advanced degree preferred with 8+ years of medical writing experience.
• Experience in pharma/biotech with regulatory writing, submissions and pharmacovigilance.
• Strong writing/editing, project management and data interpretation skills.
• Experience leading multiple writers and vendor resources across teams.
• Proficiency with Word, Adobe and document management systems; openness to AI tools.
• Detail oriented with excellent organization and adaptability.

Responsibilities

• Drive document execution for global programs, defining steps, timelines, resources and reviews for protocols, CSRs, IBs, regulatory submissions and responses.
• Lead medical writing activities for studies and programs; liaison with vendors and cross-functional teams.
• Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents.
• Support global clinical trial transparency from study registration to results posting.
• Strengthen MW function by developing processes, standards and capabilities.
• Define document development strategies and resource plans for MW activities.
• Contribute strategic MW perspective to clinical development planning and decision making.

Skills

Writing

Editing

Project management

Data interpretation

Clear communication

Team leadership

Vendor management

MS Word

Adobe

Document management

AI tools

Attention to detail

Organization

Adaptability

Education

Bachelor’s degree

Advanced degree preferred

Job description

Rhythm Pharmaceuticals Inc. in Boston is seeking an experienced Associate Director of Medical Writing to independently author and oversee clinical, regulatory, medical, and safety documents across the development lifecycle.

You will partner with cross-functional stakeholders to advance Rhythm’s mission of delivering precision medicines to patients with rare neuroendocrine diseases. The ideal candidate brings strong scientific judgment and regulatory writing expertise, plus the ability to lead