Rufus Robertson, DHA, MSc

I operate at the Senior Director level in medical writing, with over 15 years of experience leading regulatory and clinical documentation across the drug development lifecycle. I have supported biotechnology and pharmaceutical organizations including Agenus Biotechnology, Keros Therapeutics, and Austin Bio Consulting, delivering submission-ready content aligned with global regulatory expectations.My work focuses on developing and overseeing key regulatory documents, including Clinical Study Reports, Investigator’s Brochures, Development Safety Update Reports, and clinical summaries supporting IND, NDA, and BLA submissions. I bring deep expertise in CTD-aligned content, including Modules 2.4 and 2.6, with a consistent focus on scientific integrity, clarity, and compliance.I partner closely with clinical, statistical, regulatory, and medical affairs teams to translate complex data into clear, defensible narratives that support regulatory decision making. I am equally focused on how the work gets done, driving efficiency, consistency, and quality across document development.I have also led efforts to integrate AI into medical writing workflows, developing structured prompt frameworks and tools that support Medical, CMC, and Regulatory teams. These approaches have improved drafting speed, reduced variability, and strengthened overall document quality.At my core, I focus on delivering precise, compliant, and strategically aligned documentation that advances programs and supports successful regulatory outcomes.