Associate Director, Medical Writing

Responsibilities

• Own medical writing for clinical programs, delivering accurate, compliant, on-time documents

• Author protocols, clinical study reports, Investigator's Brochures and safety narratives

• Lead authoring of Module 2 summaries and FDA briefing documents for the planned NDA/MAA

• Drive document lifecycle through review, QC, approval and eCTD publishing

• Oversee medical writing vendors and contract writers

• Partner cross-functionally with biostatistics, regulatory affairs, pharmacovigilance and CMC

• Build medical writing templates, standards and processes as the function scales

Requirements

• Bachelor's degree in life sciences or related discipline

• 8+ years medical writing in biotech, pharma or CRO

• Hands-on contribution to at least one NDA, BLA or MAA submission

• Expertise with ICH E3 protocols, clinical study reports and Investigator's Brochures

• Ability to interpret TLFs, SAPs and safety data into clear scientific narrative

• Strong written and oral communication with senior stakeholders

Preferred Qualifications

• Advanced degree (MS, PhD, PharmD)

• Experience in respiratory, pulmonology or fibrotic disease programs

• Experience standing up a medical writing function in a growing biotech

• Experience with Veeva Vault, PleaseReview or similar regulatory publishing tools

Benefits

• Competitive compensation with bonus and equity

About the Company

• Celea Therapeutics develops treatments for serious respiratory diseases, led by deupirfenidone (LYT-100) in Phase 3 for idiopathic pulmonary fibrosis.