Senior Regulatory Medical Writing Lead

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); On-site; USD 142,588 - 201,472; Full time

Benefits offered by this job

Excellent benefits package

Job summary

Ionis Pharmaceuticals, Inc. seeks an Associate Director, Regulatory and Medical Writer to lead complex regulatory documentation for global submissions.

You will shape document strategy, mentor writers, and collaborate with Clinical Development, Biostatistics, and Regulatory Affairs to ensure high‑quality, compliant narratives. The role requires seasoned leadership across programs, extensive experience with Module 2/marketing applications, and strong adherence to ICH/E3/E6 guidelines in a

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 12+ years of medical writing experience in pharma.
• Lead writer for regulatory documents (CSRs, protocols, IBs).
• Experience with major regulatory submissions and Designations a plus.
• Strong knowledge of FDA/EMA/ICH guidelines.

Responsibilities

• Lead development and delivery of regulatory documents (e.g., CSR, Module 2).
• Serve as Regulatory Medical Writing lead on cross‑functional teams.
• Provide strategic input into submission planning and messaging.
• Mentor junior writers and maintain writing standards.
• Coordinate review cycles and QC of documents.

Skills

Medical writing leadership

Cross-functional collaboration

Regulatory submissions

Project management

Mentoring

Regulatory storytelling

Education

Bachelor's degree

Advanced degree preferred

Tools

Veeva

Microsoft Office

Adobe Acrobat

Job description

Ionis Pharmaceuticals, Inc. seeks an Associate Director, Regulatory and Medical Writer to lead complex regulatory documentation for global submissions.

You will shape document strategy, mentor writers, and collaborate with Clinical Development, Biostatistics, and Regulatory Affairs to ensure high‑quality, compliant narratives. The role requires seasoned leadership across programs, extensive experience with Module 2/marketing applications, and strong adherence to ICH/E3/E6 guidelines in a