Senior Medical Writer

Job Summary

A company is looking for a Senior Medical Writer.

Key Responsibilities

• Write, edit, and format clinical regulatory documents adhering to submission standards and timelines
• Ensure quality checks and proper routing of documents during review and approval cycles
• Collaborate with cross-functional teams and manage timelines for project deliverables

Required Qualifications

• Minimum of 4 years of relevant industry experience as a regulatory medical writer
• BA/BS degree required; PhD/PharmD in life sciences preferred
• Recent experience in writing regulatory documents such as clinical study reports and protocols
• Strong understanding of FDA and ICH regulatory submission requirements
• Technical expertise in Microsoft Word and Adobe Acrobat, with proficiency in other Microsoft Office applications