Remote Associate Director, Medical Writing — Phase 3 Regulatory Lead

Celea Therapeutics; Boston (MA); Hybrid; USD 195,000 - 230,000; Full time

Job summary

Celea Therapeutics is seeking an experienced Associate Director, Medical Writing to lead the clinical and regulatory documents for our Phase 3 program on deupirfenidone (LYT-100). You will set strategy, standards, and deliver high‑stakes documents while authoring key modules for regulatory submissions.

In this role, you will build the medical writing function, manage timelines, vendors, and cross‑functional partners to ensure regulatory alignment, quality, and on‑time NDA/MAA filings, with

Qualifications

• 8+ years of medical writing experience in biotech/pharma, including late‑phase programs.
• Direct NDA/BLA/MAA submission experience with CTD/eCTD structure.
• Experience authoring protocols, CSRs, and Investigator’s Brochures to ICH guidelines.
• Ability to translate clinical data into clear scientific narratives.
• Proven track record delivering complex documents on tight timelines.

Responsibilities

• Own medical writing across clinical programs and regulatory documents.
• Draft and finalize protocols, CSRs, ICF templates, and ICH modules.
• Lead NDA/MAA submission documents and briefing materials for agencies.
• Manage end-to-end document lifecycle from draft to submission-ready.
• Oversee vendors and contract writers, manage scope and budget.
• Partner cross-functionally to align documents with regulatory strategy.

Skills

Medical writing

Regulatory documents

Team leadership

AI tools

Communication

Education

Bachelor's degree in life sciences

MS/PhD/PharmD preferred

Tools

Veeva Vault

PleaseReview

StartingPoint Templates

Job description

Celea Therapeutics is seeking an experienced Associate Director, Medical Writing to lead the clinical and regulatory documents for our Phase 3 program on deupirfenidone (LYT-100). You will set strategy, standards, and deliver high‑stakes documents while authoring key modules for regulatory submissions.

In this role, you will build the medical writing function, manage timelines, vendors, and cross‑functional partners to ensure regulatory alignment, quality, and on‑time NDA/MAA filings, with