Senior CMC Writer & Strategy Lead (Hybrid/Remote)

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); Hybrid; USD 93,200 - 186,749; Full time

Job summary

Ionis Pharmaceuticals, Inc. is seeking an experienced Pharmaceutical Development professional with a primary focus on CMC content for development and late-stage drug product programs.

This role requires independent authoring, coordination, and defense of high-quality CMC content for global regulatory submissions and internal reports, while partnering with PD, Analytical, Quality, Regulatory CMC, Clinical Supply, Device, and Project Management teams.

Qualifications

• Experience writing CMC documents for regulatory submissions.
• Ability to coordinate with multiple functions (PD, Analytical, Regulatory).
• Strong scientific writing and data interpretation skills.

Responsibilities

• Serve as primary author/coordinate drug product CMC sections for regulatory submissions and related documents.
• Translate data from formulation development, manufacturing, analytics, and stability into regulatory narratives.
• Lead document planning, version control, and finalization of submission-ready CMC documents.
• Develop templates and workflows to improve consistency and efficiency across programs.

Skills

Regulatory writing

Cross-functional coordination

Documentation management

Project management

Education

Pharmaceutical Sciences

Tools

Document management systems

Job description

Ionis Pharmaceuticals, Inc. is seeking an experienced Pharmaceutical Development professional with a primary focus on CMC content for development and late-stage drug product programs.

This role requires independent authoring, coordination, and defense of high-quality CMC content for global regulatory submissions and internal reports, while partnering with PD, Analytical, Quality, Regulatory CMC, Clinical Supply, Device, and Project Management teams.