Job Description & How to Apply Below
Join Fortrea as a Senior Regulatory Medical Writer to develop complex clinical regulatory documents. Collaborate with global teams and enhance patient treatment delivery.
As a Senior Regulatory Medical Writer, you will oversee the entire development lifecycle of critical Phase II–IV documents. This role requires strong leadership and coordination with cross-functional teams, ensuring alignment with sponsor timelines and goals. You will interpret clinical data and create clear, compliant documentation tailored for regulatory submissions.
Key Responsibilities:
• Develop clinical protocols and investigator’s brochures
• Lead kick-off and communication meetings
• Coordinate contributions from multiple teams
• Ensure alignment with sponsor goals and timelines
• Translate clinical results into regulatory documents
Requirements:
• Advanced degree in life sciences (Master’s or PhD preferred)
• Minimum 4 years of regulatory writing experience
• At least 2 years leading medical writing projects
• Strong expertise in clinical study reports (CSRs)
• Excellent communication and project management skills
Elevate your writing career with a key role in clinical documentation at Fortrea.
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