Senior Regulatory Medical Writer

A company is looking for a Senior Regulatory Medical Writer (Remote; US).

Key Responsibilities

Write and provide input on routine clinical documents, including clinical study reports and study protocols

Author complex clinical and scientific documents such as IBs, bioassay reports, INDs, and MAAs

Review documents prepared by early career team members and provide training and mentorship

Required Qualifications

Bachelor's degree in a scientific field or equivalent; advanced degree preferred

5+ years of relevant experience in medical writing

Experience in the pharmaceutical or CRO industry preferred

Additional qualifications in medical writing (AMWA; EMWA; RAC) are advantageous

Equivalent combinations of education, training, and experience may be considered