Remote CMC Technical Writer — Regulatory & Analytical Expert

Content Creators; Boston (MA); Hybrid; USD 165,000 - 193,000; Full time

Job summary

Centessa Pharmaceuticals seeks a Contract CMC Technical Writer to critically review data, methods, batch records, and development reports from external CDMOs to finalize source documents for analytical, drug substance and drug product, and to prepare regulatory content and summaries.

You will write scientific content, author conclusions for submissions, and coordinate with Quality, Clinical Supply and Regulatory to align documents for modules and filings; based in the US with remote work.

Qualifications

• 12+ years of pharmaceutical/biotech experience with broad CMC expertise 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 and regulatory filing requirements.
• Ability to simplify complex scientific terminology into high-level narratives for review.
• Proficient with document management tools.

Responsibilities

• Translate data, parameters, and results from CDMOs into scientific reports with summaries and conclusions to support regulatory content and submissions.
• Review, revise, and finalize technical reports from CDMOs in support of program deliverables.
• Assist with document finalization and final source document organization, including analytical methods, validation reports, method development summaries, batch records, and campaign/production reports.
• Partner with Quality on specifications and retest/expiry documentation, and coordinate with Clinical Supply for investigational product documentation and regulatory alignments.

Skills

Scientific writing

Regulatory CMC

Regulatory documentation

Communication

Tools

Document management tools

Job description

Centessa Pharmaceuticals seeks a Contract CMC Technical Writer to critically review data, methods, batch records, and development reports from external CDMOs to finalize source documents for analytical, drug substance and drug product, and to prepare regulatory content and summaries.

You will write scientific content, author conclusions for submissions, and coordinate with Quality, Clinical Supply and Regulatory to align documents for modules and filings; based in the US with remote work.