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The Director, Medical Writing – Biologics will provide strategic and operational leadership for the preparation, development, and delivery of high-quality regulatory and clinical documents supporting the late-stage development and anticipated commercialization of SAB’s lead biologic candidate, SAB-142, and broader pipeline programs.
This role requires deep expertise in biologics regulatory writing, including leadership of Biologics License Applications (BLA), Marketing Authorization Applications (MAA), clinical study reports (CSRs), and global regulatory submissions to the FDA, EMA, and other international health authorities.
The ideal candidate will bring extensive experience supporting late-phase biologics programs within agile biotech environments, with a demonstrated ability to drive submission readiness, support commercial launch planning, and partner cross-functionally to advance programs through regulatory approval and commercialization.