Director, Medical Writing - WCH

Role: Director of Medical Writing leading complex clinical and regulatory documentation for marketed and development programs in the biopharma sector, primarily supporting Phase 1-4 clinical trials. Responsibilities: oversee the preparation of protocols, CSRs, IBs, INDs/CTAs, and submission packages; ensure compliance with ICH guidelines, SOPs, and regulatory standards; lead cross-functional collaborations with Clinical Development, Regulatory Affairs, and other teams; manage internal and external medical writing resources; mentor junior writers and oversee document quality; contribute to regulatory submission planning and industry best practices. Requirements: BSc with 12+ years or advanced degree with 7+ years in Medical Writing within pharma/biotech/CRO; extensive experience with global submissions (BLA/NDA, MAA), understanding of eCTD, ICH, FDA, EMA regulations; proven leadership in authoring and managing teams; proficient in MS Word, document management systems (Veeva, SharePoint); strong project management skills. HighValue: therapeutic areas encompass clinical development across multiple phases; focus on regulatory document creation, global submission experience, and cross-functional collaboration; leadership role in a matrix environment. WorkSetup: primarily remote, located on the West Coast; no specific travel requirements noted.