Take a pivotal role at Fortrea as a Senior Regulatory Medical Writer, leading the creation of complex clinical regulatory documents. Collaborate with global teams to drive patient-focused solutions through innovative documentation.
In this sponsor-embedded position, you will manage the development lifecycle of Phase II–IV clinical regulatory documents, ensuring alignment with timelines and sponsor objectives. Strong communication, project leadership, and regulatory knowledge are essential as you'll engage with cross-functional teams, including Biostatistics and Clinical Leadership. Your ability to interpret clinical data and produce clear, compliant documents will be crucial in this role.
Key Responsibilities:
• Lead development of Clinical Protocols and Investigator’s Brochures
• Conduct kick-off and communication meetings with stakeholders
• Coordinate cross-functional contributors and secure document alignment
• Interpret clinical data for regulatory documentation ...