Senior Medical Writing Director — Phase 3 NDA

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

Benefits offered by this job

Hybrid or remote work

Competitive compensation

Equity

Career growth

Job summary

Celea Therapeutics, Inc. in Boston is seeking an experienced Associate Director, Medical Writing to own the clinical and regulatory documents that carry our science to health authorities.

Reporting to the Senior Vice President, you will lead strategy, standards, and delivery across the portfolio—while personally authoring protocols, CSRs, and NDA-ready modules. In the near term you will deliver Phase 3 protocols and amendments, Investigator’s Brochures updates, and health authority briefing

Qualifications

• 8+ years of medical writing in biotech or pharma, including late-phase programs.
• Hands-on NDA/BLA/MAA submission experience.
• Proficiency in drafting protocols, CSRs, and Investigator’s Brochures to ICH guidelines.
• Ability to manage multiple parallel workstreams and tight timelines.

Responsibilities

• Own medical writing for clinical programs and regulatory documents.
• Author and edit protocols, CSRs, ICH E3 modules, and safety narratives.
• Lead submission documents for FDA/EMA and NDA readiness.
• Oversee vendors and contract writers, manage scope and timelines.
• Build and improve medical writing standards, templates, and workflows.
• Mentor and grow the medical writing team as the function scales.

Skills

Medical writing

Regulatory submissions

ICH E3 / eCTD

Leadership / mentoring

Education

Bachelor’s degree in life sciences

MS/PhD preferred

Tools

Veeva Vault

PleaseReview

StartingPoint Templates

Job description

Celea Therapeutics, Inc. in Boston is seeking an experienced Associate Director, Medical Writing to own the clinical and regulatory documents that carry our science to health authorities.

Reporting to the Senior Vice President, you will lead strategy, standards, and delivery across the portfolio—while personally authoring protocols, CSRs, and NDA-ready modules. In the near term you will deliver Phase 3 protocols and amendments, Investigator’s Brochures updates, and health authority briefing