Remote CMC Technical Writer – Contract

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company; Boston (MA); Remote; USD 165,000 - 193,000; Part time

Benefits offered by this job

Medical plans

Dental and vision

401(k)

Wellness programs

Job summary

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is seeking a Contract CMC Technical Writer to critically review data, batch records, and development reports from external CDMOs to finalize source documents for analytical, drug substance and drug product.

The role requires strong scientific writing, ability to translate complex data into regulatory-ready content, and collaboration with Quality, Clinical Supply, and Regulatory to support submissions.

Qualifications

• 12+ years of pharmaceutical or biotechnology industry experience across Drug Substance, Drug Product, Analytical Development, and Regulatory CMC.
• Scientific background with strong technical writing and communication skills
• Understanding of phase-appropriate documentation to support CMC development, including regulatory guidelines and filing requirements
• Ability to simplify complex scientific terminology into high-level take home narratives for ease of review
• Proficient with document management tools

Responsibilities

• Translate data, parameters, and results from various CDMOs into scientific reports with summaries and conclusions for regulatory content.
• Review, revise, and finalize technical reports from CDMOs supporting program deliverables.
• Assist with document finalization and organization, including analytical methods, validation reports, and batch records.
• Coordinate with Quality on specification and retest/expiry documentation and with Regulatory on modules and submissions

Skills

Scientific writing

Regulatory writing

CMC knowledge

Regulatory submissions

Documentation management

Communication skills

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is seeking a Contract CMC Technical Writer to critically review data, batch records, and development reports from external CDMOs to finalize source documents for analytical, drug substance and drug product.

The role requires strong scientific writing, ability to translate complex data into regulatory-ready content, and collaboration with Quality, Clinical Supply, and Regulatory to support submissions.