Director, Regulatory Writing (Temporary) at Vir Biotechnology

Candidates should possess a Bachelor's degree in a science or medical-related field with at least 15 years of industry experience, a Master's degree with 13 years of experience, or a PhD with 10 years of experience. Experience with common regulatory documents such as CSRs, IBs, DSURs, protocols, and clinical modules is required, along with an expert understanding of eCTD structure, the clinical development process, and document-related ICH guidelines and GxPs. Involvement with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents) is preferred, and at least 8 years of experience as a writer in biotechnology or an equivalent field is necessary. Applicants must be authorized to work in the U.S. without sponsorship.