Associate Director, Regulatory and Medical Writer (Pharmaceutical)

Location: Fully remote; preference will be given to San Diego-based applicants

Salary: $142,588–$201,472 annually

Company

Ionis is a biotechnology company developing RNA-targeted medicines and gene-editing approaches for serious diseases.

What you will do

• Lead the planning, authoring, and delivery of complex regulatory documents, including clinical study reports, Module 2 summaries, investigator brochures, protocols, and briefing documents.
• Act as the medical writing lead for cross-functional programs involving Clinical Development, Regulatory Affairs, Biostatistics, Safety, Quality Assurance, and Regulatory Operations.
• Provide strategic input into regulatory document planning, submission strategies, and responses to regulatory agency requests.
• Lead scientific messaging, storyboarding, data interpretation, review-cycle, and comment-resolution meetings.
• Perform quality control reviews and resolve document-related audit findings.
• Mentor medical writers and contribute to departmental writing standards and best practices.

Requirements

• Bachelor’s degree required; an advanced degree in a scientific, clinical, or regulatory field is preferred.
• 12+ years of medical writing experience in the pharmaceutical industry, including marketing applications and major regulatory submissions.
• Lead-writer experience with CSRs, protocols, investigator brochures, INDs, NDAs, Module 2 summary documents, and regulatory briefing documents.
• Extensive knowledge of FDA, EMA, and ICH guidelines, including ICH E3 and E6(R3), as well as eCTD requirements.
• Ability to interpret complex scientific and clinical data, lead cross-functional teams, manage multiple projects, and communicate complex concepts clearly.
• Proficiency in AMA style, scientific editing, formatting, document QC, Microsoft Office, Adobe Acrobat, Veeva, style guides, and lexicons.

Nice to have

• Rare disease experience.
• Experience writing regulatory designation requests such as Breakthrough Designation, Orphan Drug, Sakigake, or PRIME.
• Experience with StartingPoint templates.
• Advanced expertise in safety sections of regulatory documents.

Culture & Benefits

• Remote, hybrid, and onsite work environments are supported.
• Collaborative, scientifically rigorous, and fast-paced working environment.
• Opportunities to mentor writers and contribute to departmental standards.
• Excellent employee benefits package.

Hiring process

• A brief medical writing exercise may be requested before the interview.