Director of Medical Writing

Job Summary

To oversee medical writing activities within a portfolio of programs, the full-time Director of Medical Writing will manage the development of clinical documents, ensuring they meet regulatory requirements and program goals while working remotely.

Key responsibilities

• Develop regulatory documents for global submission in accordance with ICH guidelines and corporate objectives
• Lead and coordinate internal and external medical writing activities for assigned programs and compounds
• Participate in cross-functional meetings to provide input on medical writing deliverables and timelines

Required qualifications

• Bachelor's degree required; advanced degree in a relevant scientific/clinical/regulatory field preferred
• More than 10 years of medical writing experience in the biopharmaceutical/CRO industry required
• Demonstrated ability to interpret clinical and scientific data effectively
• Excellent project management skills with a strong understanding of clinical timelines
• Proficient understanding of global regulatory requirements and therapeutic areas in clinical development