Associate Director, Medical Writing
Structure Therapeutics
13 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
- Lead development of key regulatory and clinical documents supporting drug development programs; perform quality control (QC) reviews, document formatting, and editing to ensure compliance with regulatory standards, internal guidelines, and best practices.
Job Responsibilities
- Author, review, and finalize regulatory/clinical documents: Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, Briefing Documents, CTD Module 2 summaries, and responses to regulatory agency information requests.
- Ensure compliance with FDA/EMA/ICH requirements, internal standards, and timelines.
- Provide regulatory writing best-practice guidance (templates, processes, messaging consistency).
- Conduct comprehensive QC reviews for accuracy, internal consistency, data-driven content, and compliance.
- Verify tables/figures/references/cross-references/source data; ensure correct formatting per approved templates.
- Manage multiple projects and on-time deliverables; monitor progress, identify risks, and implement mitigation.
- Collaborate with cross-functional teams (Clinical Sciences, Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Nonclinical, CMC, Program Management); serve as liaison and support other medical writers.
Qualifications / Skills (Required)
- BA/BS or advanced degree (PhD, PharmD, MS, or equivalent) in life sciences/pharmacy or related field.
- 5+ years regulatory medical writing experience (pharma/biotech).
- In-depth global regulatory knowledge; strong communication; QC review and editing experience.
- Attention to detail; exceptional project management/organization; manage multiple projects; global teams across time zones.
- Proficient with Microsoft Word, Adobe Acrobat, EndNote, Veeva, Smartsheet.
Benefits (if applicable)
- Annual performance incentive bonus; new hire equity; performance-based equity; medical/dental/vision insurance; 401k match; unlimited PTO; paid holidays (including winter shutdown).
Application Instructions
- Apply via the official career page at BambooHR.
- Lead development of key regulatory and clinical documents supporting drug development programs; perform quality control (QC) reviews, document formatting, and editing to ensure compliance with regulatory standards, internal guidelines, and best practices.
Job Responsibilities
- Author, review, and finalize regulatory/clinical documents: Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, Briefing Documents, CTD Module 2 summaries, and responses to regulatory agency information requests.
- Ensure compliance with FDA/EMA/ICH requirements, internal standards, and timelines.
- Provide regulatory writing best-practice guidance (templates, processes, messaging consistency).
- Conduct comprehensive QC reviews for accuracy, internal consistency, data-driven content, and compliance.
- Verify tables/figures/references/cross-references/source data; ensure correct formatting per approved templates.
- Manage multiple projects and on-time deliverables; monitor progress, identify risks, and implement mitigation.
- Collaborate with cross-functional teams (Clinical Sciences, Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Nonclinical, CMC, Program Management); serve as liaison and support other medical writers.
Qualifications / Skills (Required)
- BA/BS or advanced degree (PhD, PharmD, MS, or equivalent) in life sciences/pharmacy or related field.
- 5+ years regulatory medical writing experience (pharma/biotech).
- In-depth global regulatory knowledge; strong communication; QC review and editing experience.
- Attention to detail; exceptional project management/organization; manage multiple projects; global teams across time zones.
- Proficient with Microsoft Word, Adobe Acrobat, EndNote, Veeva, Smartsheet.
Benefits (if applicable)
- Annual performance incentive bonus; new hire equity; performance-based equity; medical/dental/vision insurance; 401k match; unlimited PTO; paid holidays (including winter shutdown).
Application Instructions
- Apply via the official career page at BambooHR.