Medical Writer I

Medical Writer I at Parexel responsible for authoring and editing clinical documents for regulatory submissions. Responsibilities include gathering and analyzing resources to prepare study reports and informed consent documents, performing literature searches, ensuring FDA/EMA compliance, quality control, and preparing documents for publishing readiness. Provides medical editing and content review, and acts as primary client contact for project timelines, coordinating cross-functional teams, and facilitating reviews. Requires strong writing/editing skills, understanding of clinical research and regulatory guidelines (ICH-GCP), proficiency with MS Office and document management systems (e.g., SharePoint), and ability to work in a matrix environment. Bachelor's degree in Life Sciences or related field and experience with regulatory documents in CRO/pharmaceutical/biotech settings. English fluency essential, translation capability preferred if required.