Remote Director, Biologics CMC Technical Writing

Travere Therapeutics; Oklahoma City (OK); On-site; USD 189,000 - 246,000; Full time

Job summary

Travere Therapeutics seeks a Director of Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CMC documentation for regulatory submissions like BLA. You will guide the development of Module 2 summaries and Module 3 sections, coordinating with Regulatory Affairs and SME teams.

The ideal candidate has extensive experience authoring Module 3 content for biologics, with strong scientific judgment, writing skills, and ability to drive decisions across cross-functional

Qualifications

• Bachelor's degree in pharmaceutical sciences, chemical engineering, biotechnology, or related field.
• MS/PhD preferred.
• 10+ years in pharma/biotech with CTD Module 2 and Module 3 experience.
• Strong knowledge of biologics development, manufacturing, analytics, and process validation.

Responsibilities

• Lead the planning, authoring, and delivery of CMC content for regulatory submissions such as the BLA.
• Translate complex technical data into regulator-ready narratives.
• Develop document strategies, content plans, timelines, templates, and authoring standards for the CMC submission.
• Author and coordinate sections covering drug substance/product manufacturing, process development, characterization, validation, and control strategies.
• Ensure consistency across Module 3 sections and alignment with regulatory strategy and data.

Skills

Technical writing

Regulatory submissions

Cross-functional collaboration

PowerPoint proficiency

Education

Bachelor's degree in pharmaceutical sciences / chemical engineering / biotechnology

MS/PhD preferred

Tools

CTD Module 2/3 experience

Biologics development knowledge

Job description

Travere Therapeutics seeks a Director of Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CMC documentation for regulatory submissions like BLA. You will guide the development of Module 2 summaries and Module 3 sections, coordinating with Regulatory Affairs and SME teams.

The ideal candidate has extensive experience authoring Module 3 content for biologics, with strong scientific judgment, writing skills, and ability to drive decisions across cross-functional