Job Details

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 documentsAuthor content for regulatory submissions, ensuring compliance with writing standards and guidelinesMentor less experienced medical writers and contribute to the development of departmental strategiesRequired Qualifications:Bachelor's degree in a scientific or clinical discipline; Ph.D. preferredMinimum of 7 years of clinical/regulatory medical writing experience in pharma or biotechExperience with eCTD Module 2 and Module 5 writing for global MAAsBasic understanding of scientific methodology and drug development processesProficient in MS Office and capable of managing multiple projects simultaneously