Senior Manager & Editor FDA Submissions

Together We Innovate. Together We Change

Support communications on complex scientific regulatory submissions for a Fortune 200 Company with some of the most iconic brands! Have an advanced degree with ten years of professional experience? Do you have experience in medical, scientific or regulatory editing or writing? If so, we want to speak with you!

We are currently seeking a Senior Manager, Editor, FDA Submissions to join our Regulatory Affairs (RA) organization in Richmond, VA or we are open to remote work arrangements.

The Senior Manager, Editor, FDA Submissions will manage content development of high-quality documents for FDA product applications and other scientific communications  including editing and writing of complex scientific information in clear and compliant written communications.  You will edit and proofread a range of content including printed materials and slide presentations to ensure clarity, accuracy, and consistency of the written materials and application of required style.

What you'll be doing:

• 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 with scientists, senior management, project managers and science authors to deliver best written product
• Supervise contract resources as needed and ensure adequate quality and version control of large-scale documents

We want you to have:

• Bachelor’s or Advanced Degree in a regulatory, law, science or related field.  Advanced degree preferred.
• 10+ years of relative experience writing or editing business, public affairs, regulatory or legal documents          
• Understanding of FDA processes, experience developing FDA submissions preferred       
• Advanced written and editorial skills, and strong attention to detail.         
• Demonstrated ability to synthesize complex information using excellent critical thinking skills 
• Demonstrated success applying engagement and collaboration skills to including influencing without authority across broad and diverse stakeholder groups            
• Excellent interpersonal skills, analytical and critical thinking.