Senior Regulatory Medical Writer

Job Summary

Working remotely in a full-time capacity, the Senior Regulatory Medical Writer will provide high-quality medical and scientific writing, collaborating with internal and external clients to produce clinical regulatory documents and ensuring compliance with regulatory guidelines.

Key responsibilities

• Serve as the primary author for clinical documents, including clinical study reports and study protocols
• Collaborate with cross-functional teams to ensure the accuracy and completeness of documents
• Manage project timelines and deliverables while mentoring junior medical writers

Required qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred
• Minimum of 5 years of relevant experience in the pharmaceutical or CRO industry
• Experience in authoring clinical regulatory documents
• Additional qualifications in medical writing (AMWA, EMWA, RAC) are advantageous
• Strong knowledge of global and regional document development guidelines