Director of Medical Writing

Job Summary

A company is looking for a Director of Medical Writing to manage medical writers and author content for regulatory submissions.

Key Responsibilities:

• Manage medical writers and oversee the development of regulatory documents
• Author content for regulatory submissions, ensuring compliance with writing standards and guidelines
• Mentor less experienced medical writers and contribute to the development of departmental strategies

Required Qualifications:

• Bachelor's degree in a scientific or clinical discipline; Ph.D. preferred
• Minimum of 7 years of clinical/regulatory medical writing experience in pharma or biotech
• Experience with eCTD Module 2 and Module 5 writing for global MAAs
• Basic understanding of scientific methodology and drug development processes
• Proficient in MS Office and capable of managing multiple projects simultaneously