Senior Medical Writer

Job Summary

A company is looking for a Principal Medical Writer who will provide high-quality medical and scientific writing for clinical and regulatory documents.

Key Responsibilities

• Write and provide input on clinical documents such as study reports and protocols, as well as complex scientific documents like INDs and MAAs
• Review documents prepared by junior team members and provide training and mentorship on document preparation and regulatory requirements
• Ensure compliance with quality processes and may assist in program management activities including developing timelines and budgets

Required Qualifications

• Bachelor's degree in a scientific field; advanced degree preferred
• 5+ years of relevant experience in medical writing, preferably in the pharmaceutical/CRO industry
• Experience in a client-dedicated role or with multiple projects preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) are advantageous
• Equivalent combinations of education, training, and experience may be considered