Associate Director of Medical Writing

Job Description - Associate Director of Medical Writing

A company is looking for an Associate Director of Regulatory Medical Writing. Key Responsibilities Manage medical writers and oversee the development of regulatory documents Author clinical content and ensure compliance with internal standards and regulatory requirements Collaborate with clinical project teams to meet project deadlines and maintain inspection-readiness Required Qualifications Bachelor?s degree in a scientific or clinical discipline; PhD preferred Minimum of 5 years of clinical/regulatory medical writing experience in pharma or biotech Familiarity with FDA and ICH guidelines for clinical reporting Experience with eCTD development and submission preferred Basic understanding of clinical development processes and regulatory document preparation