Description
Bristol Myers Squibb is hiring a Manager, Expert Scientific Writer to lead the authoring of clinical and regulatory documents for Japan, including clinical study reports, CTD submissions, PMDA briefing and response documents, and orphan drug designation materials. The role manages timelines, quality, global submission materials, outsourced vendors, regulatory inspections, process improvements, and collaboration with global and Japanese stakeholders. Candidates need a relevant medical, pharmaceutical, veterinary, or life-science degree or three years of pharmaceutical R&D experience, strong Japanese and English writing skills, and experience preparing regulatory submission documents.
