Senior Medical Writer

Job Summary

A company is looking for a Sr. Medical Writer to lead medical writing projects and produce regulatory documents.

Key Responsibilities

• Lead the content planning and production of regulatory documents that align with established standards and guidelines
• Coordinate document reviews and develop timelines for assigned writing projects
• Provide mentorship to junior writing team members and support project leads with timeline development

Required Qualifications

• Minimum of an undergraduate degree (advanced degrees preferred) and 7-9 years of relevant experience in medical writing
• Previous experience with clinical study reports, investigator brochures, protocols, and informed consent forms
• Trained in GCP, GDPR, and HIPAA
• Expertise with EndNote/reference software
• Familiarity with ICH M11 and the AMA Style Guide is an asset