Shaila Sarathy

About Shaila Sarathy

I am an Assistant Medical Writer engaged in regulatory writing and clinical documentation within the biopharmaceutical industry, with a public health background. I contribute to the development, revision, and quality control of regulatory and clinical documents for health authority submissions.My role involves independent authorship and revision of clinical and scientific documentation, as well as cross-functional collaboration with clinical, regulatory, and scientific teams. I translate clinical data and scientific evidence into clear, accurate, and compliant written content aligned with regulatory requirements.I am currently pursuing a Master of Public Health (MPH) at Johns Hopkins University, with academic interests in health policy and global health. I am particularly interested in roles in regulatory writing, regulatory affairs, medical affairs, and medical communications within biotech or pharma, especially those that involve cross-functional collaboration and work in regulated environments.I am motivated by work where strong data interpretation, scientific communication, and compliance-driven writing support informed decision-making and improved patient outcomes.

Experience

1. Medical Writing Assistant

   Gilead Sciences

   Aug 2023 — Present · Foster City, CA, US

   Perform regulatory writing and revision of clinical and regulatory documents for health authority submissions, ensuring accuracy, consistency, and compliance with regulatory standards.Author and update clinical and scientific documentation, incorporating clinical data, literature, and stakeholder feedback.Conduct quality control reviews of regulatory documents, including formatting, content accuracy, and adherence to internal style guides and regulatory requirements.Collaborate cross-functionally with clinical, regulatory, medical, and scientific teams throughout document development and review cycles.

Education

• The Johns Hopkins University

  Master of Public Health - MPH

• UC San Diego

  General Biology , None

  2019 — 2023