Senior Medical Writer

Role: Senior Medical Writer supporting global clinical development for rare genetic diseases at BioMarin. Objectives: develop and finalize regulatory and study reporting documents, ensure documentation quality and compliance across programs. Responsibilities: draft/edit clinical study protocols, amendments, informed consent forms, clinical study reports; prepare regulatory documents like investigator’s brochures, safety reports, briefing books; manage cross-functional team collaboration, establish timelines, and review processes. Requirements: up to 6 years of medical/scientific writing experience or 10+ years in medical writing; Bachelor's or higher degree, preferably scientific; proficiency in clinical and regulatory documentation including protocols, CSR, IND/NDAs, PBRERs, DSURs, and regulatory submissions; expert knowledge of clinical development, biostatistics, regulatory guidelines, and document management software. Preferred: experience with eCTD submissions, regulatory intelligence, and advanced project management skills. High-Value: focus on clinical study documentation for drugs in development for rare disorders, with extensive regulatory document expertise and cross-functional collaboration, including study teams and regulatory affairs.