Associate Director, Medical Writing — Regulatory Lead

Structure Therapeutics; South San Francisco (CA); On-site; USD 186,000 - 235,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Unlimited PTO

Paid holidays

Job summary

Structure Therapeutics is seeking an Associate Director of Medical Writing to lead the development of regulatory and clinical documents for its drug programs. The role requires expertise in regulatory writing, QC, and cross‑functional collaboration to ensure compliant, timely submissions.

You will manage multiple projects, mentor writers, and align messaging across documents while partnering with Clinical Sciences, Regulatory Affairs, Biostatistics, and other teams.

Qualifications

• Bachelor's degree in life sciences, pharmacy, or related field.
• 5+ years of regulatory medical writing experience.
• Knowledge of global regulatory requirements, guidelines, and drug development.
• Experience authoring regulatory and clinical documents.
• Excellent written and verbal communication skills.
• Extensive experience performing quality control reviews of regulatory documents.
• Strong project management and organization skills.
• Experience with global teams across multiple time zones.

Responsibilities

• Lead authoring, review, and finalization of high‑quality regulatory and clinical documents, including CS Protocols, CSRs, Investigator Brochures, Briefing Documents, CTD Module 2 summaries, and responses to regulatory information requests.
• Ensure all documents comply with regulatory requirements (FDA, EMA, ICH) and internal standards and timelines.
• Provide strategic guidance on regulatory writing best practices, templates, and processes.

Skills

Regulatory writing

Project management

Cross-functional collaboration

Quality control

Education

Bachelor's degree in life sciences or related field

5+ years regulatory medical writing experience

Tools

Microsoft Word

Adobe Acrobat

EndNote

Veeva

Smartsheet

Job description

Structure Therapeutics is seeking an Associate Director of Medical Writing to lead the development of regulatory and clinical documents for its drug programs. The role requires expertise in regulatory writing, QC, and cross‑functional collaboration to ensure compliant, timely submissions.

You will manage multiple projects, mentor writers, and align messaging across documents while partnering with Clinical Sciences, Regulatory Affairs, Biostatistics, and other teams.