Associate Director, Medical Writing (Clinical and Regulatory)

Responsibilities

• Develop and implement inputs for clinical and regulatory documents
• Manage document workflow from drafting to approval efficiently
• Support cross-functional teams as the Medical Writing expert
• Implement clinical transparency and disclosure practices
• Build collaborative relationships with key stakeholders
• Participate in writing strategy and standards initiatives
• Distill complex clinical data into clear presentations

Qualifications

• BS, MS, or doctorate in a scientific or medical field
• 6+ years in biotechnology/pharmaceutical industry
• Experience in medical writing, editing, and clinical development with specific document types (protocols, IBs, CSRs)
• Leadership, planning, and project management skills
• Prominent oral and written communication skills
• Experience with rare diseases or gene therapy is a plus