IDEAYA Biosciences

  • South San Francisco, CA, United States
IDEAYA Biosciences South San Francisco, CA, USA
Position Summary We are seeking a highly motivated, well-organized, and skilled Associate Director or Director of Medical Writing to lead cross-functional teams in content preparation for submission to regulatory authorities; partners closely with key stakeholders, applies critical thinking, scientific writing, data interpretation, and knowledge of regulatory content life cycle. What you'll do: Lead the preparation of clinical and regulatory documents (eg, protocols, investigator brochures, safety updates, IND and NDA modules, clinical study reports, and briefing documents) in accordance with applicable global and regional regulatory guidelines, and IDEAYA and Company partners’ standards/SOPs Plan content in partnership with functional leads and create timelines for development of assigned documents Responsible for organization, clarity, scientific standards, formatting, and consistency of content within and across all documents for a program or within a clinical dossier Lead...