Associate Director, Medical Writing
- Compensation
- Not disclosed
- Location
- Boston
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Contract
- Experience
- 8+ years
- Category
- Not specified
- Posted
Skills
Must have
- Bachelor’s degree in life sciences or a related scientific discipline; an advanced degree (MS, PhD, PharmD) is preferred; equivalent experience considered.
- 8+ years of medical writing experience in the biotech or pharmaceutical industry (or CRO), including substantial experience authoring documents for late-phase clinical programs.
- Direct, hands-on contribution to at least one NDA (or BLA/MAA) submission — authoring clinical modules such as the Clinical Overview, Clinical Summaries, or integrated summaries of safety and efficacy
- Demonstrated expertise authoring protocols, clinical study reports, and Investigator’s Brochures to ICH E3 and related guidance, with a working command of the CTD/eCTD structure.
- Ability to interpret clinical and statistical output — TLFs, SAPs, safety data — and translate it into a clear, defensible scientific narrative.
- Track record of delivering complex, high-visibility documents on tight timelines while managing multiple parallel workstreams and review cycles.
- Excellent written and oral communication skills, with the ability to lead cross-functional review discussions and drive consensus among senior stakeholders.
- Entrepreneurial mindset and comfort operating in a fast-paced, early-stage environment.
- Proficiency using AI tools to work smarter — curiosity about how technology can improve the quality and speed of your work.
Nice to have
- Experience in respiratory, pulmonology, or fibrotic disease programs, or with small-molecule products in late-stage development.
- Experience building or standing up a medical writing function in a small or growing clinical-stage biotech, including template and process development.
- Experience with regulatory publishing systems and document management platforms (e.g., Veeva Vault, PleaseReview, StartingPoint Templates), and familiarity with AMA style.
Full description
About Celea Therapeutics
Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” our name reflects our mission to rise above the status quo and deliver therapies that change lives. Our lead program, deupirfenidone (LYT-100), is currently in Phase 3 clinical development with active candidate enrollment, representing a potential new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.
Rising above the status quo takes a team as strong as its science, and we hire and work by five values: accountability — owning outcomes and acting like owners; transparency — talking straight and building trust; collaboration — achieving together what no one could alone; innovation — challenging accepted ideas and taking smart risks; and passion — bringing energy and heart to the mission.
Position Overview
As we advance deupirfenidone (LYT-100) through Phase 3 toward registration, Celea is seeking an experienced, strategic, and hands-on Associate Director, Medical Writing to own the clinical and regulatory documents that carry our science to health authorities. Reporting to the Senior Vice President, Clinical Operations and Program Strategy, you will own medical writing strategy, standards, and delivery across the portfolio — while personally authoring the highest-stakes documents, from protocols and clinical study reports through the clinical modules of our planned NDA.
In the near term, your focus will be delivering Phase 3 protocols and amendments, clinical study reports, Investigator’s Brochure updates, and health authority briefing documents on timelines that protect the program’s critical path. Over time, you will build the medical writing function — templates, style standards, vendor strategy, and submission-ready processes — and serve as a core contributor to NDA authoring and readiness, making you instrumental in guiding Celea through its next chapter.
This position is open to hybrid or remote work.
Key Responsibilities
- Own medical writing for Celea’s clinical programs; deliver scientifically rigorous, regulatory-compliant documents that are accurate, consistent, and on time.
- Author, edit, and finalize core clinical documents — protocols and amendments, informed consent form templates, clinical study reports, Investigator’s Brochures, safety narratives, and clinical sections of the Development Safety Update Report.
- Lead authoring of clinical regulatory submission documents, including Module 2 summaries (2.5 Clinical Overview, 2.7 Clinical Summaries), integrated summaries of safety and efficacy, and briefing documents for FDA and international health authority meetings, in support of the planned NDA/MAA.