Compliance

• Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards
• Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed
• Monitors timelines and budgets for assigned projects
• Provides technical support and expertise as appropriate
• Conducts training of medical editing staff and functions as a mentor
• Advises medical writers, medical editors, and study teams on quality review
• Provides training to members of the global medical writing team
• Serves as project lead for deliverables of assigned complex projects
• Serves as a member of the medical writing team for projects with medical writing deliverables
• Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style
• Performs quality review of assigned documents
• Contributes to the development of process improvement tools
• Manages assigned projects according to medical writing standard operating procedures

Senior Medical Editor – Copy Editing, QC, Regulatory

Regulatory Affairs Specialist – Group Leader – Crop Protection

Local Regulatory Affairs Manager – Freelance/Part-time

Senior Regulatory and Start Up Specialist

Senior Regulatory and Start Up Specialist