Principal Medical Writer II

Job Summary

Working remotely, the full-time salaried Associate Director, Principal Medical Writer II will manage the development of clinical documents for regulatory submissions globally, providing strategic direction to cross-functional teams and ensuring high-quality, scientifically rigorous documentation.

Key responsibilities

• Lead the preparation and compilation of regulatory documents, ensuring adherence to ICH guidelines and corporate objectives
• Oversee medical writing activities for multiple compounds and mentor less experienced writers
• Participate in cross-functional meetings to provide input on medical writing deliverables and timelines

Required qualifications

• Bachelor's degree or equivalent experience required; advanced degree in a relevant field preferred
• Proficient understanding of global regulatory requirements and clinical development processes
• Excellent project management skills with a deep understanding of clinical timelines
• Experience with electronic document management systems and templates
• Demonstrated ability to independently lead the development and approval of clinical documents