Associate Director, Medical Writing

Role: Associate Director of Medical Writing in a clinical-stage biopharma focused on autoimmune diseases, responsible for developing complex regulatory documents to support global drug submissions. Responsibilities include authoring protocols, IND/BLAs, CSRs, ICFs, and specialty regulatory documents; ensuring document quality and consistency; managing internal and external medical writers; and facilitating inspection readiness. The role involves collaborating with cross-functional teams such as clinical, biostatistics, and regulatory affairs to meet project timelines and regulatory standards. Requirements include a Bachelor's degree (PhD preferred), at least 5 years of sponsor-level pharma or biotech medical writing experience (CRO experience considered), fluency in American English, and proficiency in eCTD Modules 2 and 5. Familiarity with regulatory guidances, pharmacovigilance documents, and document management systems like Veeva Vault is preferred. The position emphasizes strong communication, multitasking, and autonomous working skills. The role is ideally suited for candidates on the East Coast of the U.S., with a salary range of $164,000–$225,500 and eligibility for incentive programs and benefits.