Director, Medical Writing WCH

Role: Director of Medical Writing leading complex clinical and regulatory documentation for marketed and development programs within the Therapeutic Area, focusing on ensuring scientific accuracy, regulatory compliance, and strategic messaging. Responsibilities: oversee global document preparation (protocols, CSRs, IBs, INDs/CTAs), manage and mentor medical writing teams and external vendors, support regulatory submissions (BLA/NDA, MAA), develop SOPs, and collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, and Biostatistics. Also engage in industry outreach and represent Medical Writing in governance and regulatory meetings. Requirements: Bachelor's degree + 12+ years (or advanced degree + 7+ years) in Medical Writing within pharma/biotech/CRO, with extensive experience in global regulatory documentation (e.g., BLA/NDA), familiarity with eCTD, ICH, FDA, EMA guidelines, and proven leadership in document authoring and team management. Preferred skills include vendor management, project management, and proficiency in document systems (Veeva, SharePoint). High-value: expertise across all clinical development phases (1-4), regulated environments, strategy development, and cross-functional stakeholder engagement. Location: West Coast hub with likely hybrid setup; travel not specified.