Associate Director, Medical Writing - Remote

Overview

The Associate Director, Medical Writing will support the development of high-quality clinical and regulatory documents that assist in drug development programs.

In Short

• Lead the development of clinical and regulatory documents.
• Collaborate with cross-functional teams.
• Ensure compliance with ICH guidelines and regulatory requirements.
• Mentor junior writers.
• Work in a remote position with potential travel.
• Manage timelines and deliverables.
• Develop and maintain writing templates and best practices.
• Support regulatory submissions including INDs and NDAs.
• Contribute to building the medical writing function.
• Adapt to changing deadlines and priorities.

Requirements

• Advanced degree in life sciences (PhD, PharmD, or MS preferred).
• 8+ years of experience in medical writing in the biotech/pharmaceutical industry.
• Strong knowledge of ICH, FDA, and EMA guidelines.
• Excellent writing and editing skills.
• Ability to work independently in a fast-paced environment.
• Experience with StartingPoint templates and Microsoft Project is a plus.
• High attention to detail.
• Ability to work collaboratively.
• Flexible with changing priorities.
• Project management skills.

Benefits

• Fully remote position.
• Opportunity to travel and meet with teams.
• Be a critical part of drug development.
• Work in a dynamic start-up environment.
• Contribute to improving patient care.