Director of Medical Writing - Remote

Overview

The primary objective of the Director, Medical Writing is to provide technical and medical writing support, including data presentation and document strategy expertise, to a variety of document and submission types.

In Short

• Work with clinical and regulatory teams to prepare various documents in CTD format.
• Ensure efficient formatting and consistent style of documents.
• Lead decision-making about data presentation and document strategies.
• Develop and maintain document timelines for assigned programs.
• Contribute to project management and cross-functional working groups.
• Lead development of annual medical writing timelines.
• Serve as a lead author for key study reports.
• Manage and mentor junior writers.
• Lead process improvement initiatives.
• Represent Medical Writing at various team levels.

Requirements

• Bachelor’s degree; Advanced degree preferred.
• 10+ years' experience in medical writing in the pharmaceutical/biotechnology environment.
• Knowledge of biologics development, clinical research, and regulatory requirements.
• Experience in rare disease, ophthalmology, and/or nephrology preferred.
• Experience in a start-up environment preferred.

Benefits

• Comprehensive benefits package including 401(k) plan with company match.
• Inclusive family building benefits.
• Flexible time off and summer/winter shutdowns.
• Paid family leave, disability, and life insurance.