Associate Director, Medical Writing

Position Summary
- Lead development of key regulatory and clinical documents, and perform quality control (QC) reviews, document formatting, and editing to ensure compliance with regulatory standards, internal guidelines, and best practices.

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, and ICH requirements, internal standards, and timelines.
- Provide strategic guidance on regulatory writing best practices, templates, and processes.
- Conduct comprehensive QC reviews for accuracy, consistency, data integrity, and compliance.
- Verify formatting and presentation of tables, figures, references, cross-references, and source data; ensure correct template/style-guide submission requirements.
- Manage deliverables across multiple projects; collaborate with cross-functional teams (Clinical Sciences, Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Nonclinical, CMC, Program Management).
- Monitor project progress, identify risks, and support mitigation.

Qualifications/Skills
- BA/BS or advanced degree (PhD, PharmD, MS, or equivalent) in life sciences/pharmacy or related field.
- 5+ years regulatory medical writing experience in pharma/biotech.
- In-depth global regulatory knowledge; strong authoring/QC/editing experience.
- Excellent communication; exceptional attention to detail.
- Strong project management; ability to manage multiple projects in fast-paced settings.
- Proficiency: Microsoft Word, Adobe Acrobat, EndNote, Veeva, Smartsheet.

Benefits
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical/dental/vision; 401k match; unlimited PTO; paid holidays (including winter shutdown).

Application instructions
- Apply via the official career page at BambooHR.