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Role:
- Act as primary Regulatory Medical Writer for high-complexity Phase II-IV documents.
- Lead kick-off strategy meetings and align geographically distributed teams.
- Critically interpret study data into clear language for protocols and CSRs.
Collaboration:
- Coordinate with Biostatistics, Data Management, Programming, Clinical Leadership, and Project Physician teams.
- Engage with medical writing teams across Europe, Americas, and Asia-Pacific.
- Maintain alignment with sponsor goals and foster regular communication with functional leads.
Qualifications:
- Advanced degree in life sciences (PhD or Masters).
- Minimum 4 years regulatory medical writing experience, including 2 years as project lead.
- Proven ability to independently author content and drive the review process.
Fortrea
Fortrea delivers solutions that bring life-changing treatments to patients faster. They are a global organization that empowers employees to shape their own career path with comprehensive training and management support.