Senior Regulatory Medical Writer

Job Summary

A company is looking for a Principal Medical Writer to provide high-quality medical and scientific writing in a remote capacity.

Key Responsibilities

• Write and provide input on clinical documents such as study reports and protocols, summarizing data from clinical studies
• Author complex clinical and scientific documents, including IBs, bioassay reports, INDs, and MAAs
• Review documents prepared by junior team members and may 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, preferably in the pharmaceutical or CRO industry
• Experience in a client-dedicated role or with multiple projects is preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) are advantageous
• Combination of education, training, and directly related experience may be considered