Responsibilities

The Senior Manager, Medical Writing will author a wide variety of documents of all types and complexities, such as clinical study reports (CSRs all phases), investigator’s brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses. They will represent Medical Writing in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for optimal presentation of data to achieve document intent. They will plan and oversee assigned medical writing deliverables, including development and management of document timelines and resource planning for assigned projects. They may serve as the filing lead for small to medium regulatory submissions and may serve as lead medical writer and department representative across development programs. The role involves participating in the development/improvement of document standards, templates, and processes, and may also involve coaching, training, and providing guidance to less experienced Medical Writing colleagues. They will manage or supervise contractors to ensure the highest quality of medical writing and adherence to Gilead documents standards.