Principal Medical Writer

A company is looking for a Principal Medical Writer.

Key Responsibilities

Produce high-quality clinical documents and manage the review process

Independently develop and revise key clinical documents and lead regulatory submissions

Provide medical writing expertise and collaborate with various project teams

Required Qualifications

Bachelor's degree in Life Science or English / Communications; advanced degree preferred

7+ years of medical writing experience in a sponsor / CRO setting, with regulatory submission experience preferred

In-depth knowledge of Good Clinical Practices, FDA regulations, and ICH guidelines

Experience overseeing contract writers and managing multiple projects in a fast-paced environment

Knowledge of eCTD formatting and EDMS systems preferred