Senior Medical Writer

Role: Senior Medical Writer supporting clinical documentation in rare disease therapeutics. Responsibilities: draft, review, and finalize clinical study documents (protocols, amendments, reports), regulatory filings (INDs, NDA modules), and safety reports; manage cross-functional team collaborations; develop templates and standards; ensure compliance with regulatory requirements and quality standards. Requirements: Bachelor's degree (science preferred); up to 6 years of medical writing experience in pharma or 10+ years as a primary science writer; expertise in clinical trial documentation, regulatory documents (e.g., INDs, BLA/NDAs, PBRERs, DSURs), and clinical research concepts; proficient in Microsoft Office, document management tools, and regulatory standards. Preferred: experience with eCTD modules, medical dictionaries (MedDRA, WHO Drug), and scientific concepts related to drug development (nonclinical, CMC, PK/PD). HighValue: rare disease focus, biologics or small molecule modalities, involvement in clinical development stages from discovery to regulatory submission, collaboration with global cross-functional teams. WorkSetup: not specified; position involves working with global teams, likely hybrid or remote based on operational needs.