FDA Submissions Editor

Job Summary

A company is looking for a Senior Manager & Editor FDA Submissions.

Key Responsibilities

• Ensure timely delivery of consistent, high-quality, accurate and complete written materials
• Write and edit large-scale FDA submission documents, effectively integrating science and advocacy
• Manage internal stakeholder relationships and supervise contract resources as needed

Required Qualifications

• Bachelor's or Advanced Degree in a regulatory, law, science or related field; advanced degree preferred
• 10+ years of relevant experience writing or editing business, public affairs, regulatory or legal documents
• Understanding of FDA processes and experience developing FDA submissions preferred
• Demonstrated ability to synthesize complex information using excellent critical thinking skills
• Demonstrated success in engagement and collaboration skills across diverse stakeholder groups