Fizza Shaikh

Background

About Fizza Shaikh

I am a Technical Writer and Editor with over 17 years of experience in healthcare, pharmaceuticals, and regulatory compliance, including 9 years in supervisory roles. I specialize in FDA submissions, CGMP documentation, and SOP development, with a proven track record of delivering clear, accurate, and audit-ready documentation. Throughout my career, I’ve partnered with cross-functional teams, regulators, and global manufacturers to simplify complex scientific and regulatory information into accessible communication that supports compliance and advances public health. My leadership experience includes coaching and developing technical writing teams, improving documentation processes, and ensuring consistency across high-stakes communications. Core Expertise: Technical Writing & Editing FDA & CGMP Compliance Regulatory Submissions SOP Development Team Leadership & Training Virtual Collaboration (Teams, Slack, Outlook) I’m passionate about bridging the gap between technical detail and practical understanding—helping organizations communicate more effectively while meeting stringent regulatory requirements.