Amy Mackay is a dedicated Manager of Medical Writing at Gilead Sciences, where she leverages her extensive expertise in regulatory submissions to drive critical oncology projects forward. With a strong focus on patient care, Amy excels in translating complex scientific information into clear, accessible language,...
Amy Mackay is a dedicated Manager of Medical Writing at Gilead Sciences, where she leverages her extensive expertise in regulatory submissions to drive critical oncology projects forward. With a strong focus on patient care, Amy excels in translating complex scientific information into clear, accessible language, ensuring that regulatory documents resonate with both regulatory bodies and the patients they ultimately serve. Her role as the lead and co-lead Medical Writing representative for significant submissions, including the Japan NDA and the Type II Variation for the EMA, highlights her ability to manage intricate timelines and coordinate efforts among internal teams and external medical writers.
Amy's proficiency in authoring key regulatory documents, such as Module 2 Common Technical Document (CTD) submissions, Clinical Study Reports (CSRs), and safety narratives, underscores her comprehensive understanding of the regulatory landscape. Her experience in developing briefing books and Assessment Aids further demonstrates her capability to support strategic communications with regulatory agencies. A true team player, Amy fosters collaboration and encourages open communication within her team, ensuring that all voices are heard and that project goals are met efficiently.
In addition to her regulatory writing skills, Amy is adept in data analysis and project management, utilizing tools like Microsoft Excel and Adobe Acrobat to streamline workflows and enhance document quality. Her scientific background, including techniques such as Western Blotting and PCR, complements her writing expertise, allowing her to bridge the gap between complex data and regulatory requirements effectively. Passionate about improving patient outcomes, Amy remains committed to advancing the field of oncology through her meticulous and patient-centered approach to medical writing.
