Senior Scientific Writer

Job Summary

To support clinical development across multiple therapeutic areas, the full-time remote Senior Scientific Writer will draft and manage reviews for Clinical Bioanalysis and Clinical Pharmacology submission documents while leading document meetings and collaborating with cross-functional teams.

Key responsibilities

• Independently draft and manage review of reports and summaries for Clinical Pharmacology and Clinical Bioanalysis
• Lead Kickoff, Author, and Comment Reconciliation meetings for assigned documents
• Manage multiple projects and timelines while attending cross-functional program meetings

Required qualifications

• BS degree with 2+ years of relevant experience, or MS/PhD/PharmD in a life science
• 1-2 years of relevant industry experience in a biotech/pharma setting
• Preferred experience using digital technology-based solutions to streamline content creation
• Basic understanding of the eCTD and drug development process
• Strong background in protein therapeutics and/or gene therapy is a plus