Medical Writer

Role: Senior Medical Writer supporting Viking Therapeutics' clinical development through authoring and reviewing regulatory and clinical documents. Responsibilities: produce protocols, clinical study reports, investigator brochures, informed consent forms, safety reports, and regulatory submission sections; coordinate with cross-functional teams and external vendors; ensure compliance with GxP, ICH-GCP, and regulatory standards; manage document timelines and review processes; contribute to process improvements. Requirements: Bachelor's in life sciences or related field with 4+ years' relevant experience or advanced degree with equivalent expertise; proven track record in clinical and regulatory document authoring within a GCP environment; strong knowledge of ICH-GCP, CTD/eCTD frameworks, and regulatory expectations for clinical documentation; excellent scientific writing skills and proficiency with MS Word, document management, and literature tools. Preferred: experience in metabolic, endocrine, or obesity/GLP-1 therapeutic areas, and outsourcing to CROs. HighValue: experience in metabolic/endocrine research, regulatory submission work, and managing cross-functional and external collaborations. WorkSetup: Details not specified; likely hybrid or office-based.