Senior Regulatory Medical Writer

Job Summary

A company is looking for a Principal Medical Writer to join their Medical Writing Functional Service Partnership team.

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 Investigator's Brochures and regulatory submissions
• Review documents prepared by junior team members and provide training and mentorship on document preparation and regulatory requirements

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 is preferred
• Additional qualifications in medical writing (e.g., AMWA, EMWA, RAC) are advantageous
• Equivalent combinations of education, training, and experience may be considered