Associate Director, Medical Writing — Regulatory Leader

Structure Therapeutics Inc.; South San Francisco (CA); Hybrid; USD 186,000 - 235,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Unlimited PTO

Winter shutdown/paid holidays

Job summary

Structure Therapeutics Inc. in California is seeking an Associate Director of Medical Writing to lead the development of regulatory and clinical documents, ensuring compliance with FDA, EMA and ICH guidelines, and maintaining high quality across programs.

The role emphasizes cross-functional collaboration, project leadership, and QC oversight, with opportunities to mentor writers and implement best practices, templates, and processes to improve messaging and submission readiness.

Qualifications

• 5+ years of regulatory medical writing experience in pharma/biotech.
• Deep knowledge of FDA, EMA, ICH guidelines and regulatory submissions.
• Excellent written/verbal communication and editing skills.

Responsibilities

• Lead authoring and review of regulatory and clinical documents (e.g., CSRs, IBs, CTD summaries).
• Perform QC and ensure formatting, accuracy, and compliance with templates and guidelines.
• Collaborate across Clinical Sciences, Regulatory Affairs, Biostatistics, and Program Management.

Skills

Regulatory medical writing

Cross-functional collaboration

Project management

Attention to detail

Regulatory strategy guidance

Education

BA/BS in life sciences

Advanced degree (PhD/PharmD/MS)

Tools

Microsoft Word

Adobe Acrobat

EndNote

Veeva

Smartsheet

Job description

Structure Therapeutics Inc. in California is seeking an Associate Director of Medical Writing to lead the development of regulatory and clinical documents, ensuring compliance with FDA, EMA and ICH guidelines, and maintaining high quality across programs.

The role emphasizes cross-functional collaboration, project leadership, and QC oversight, with opportunities to mentor writers and implement best practices, templates, and processes to improve messaging and submission readiness.