Editor - Regulatory Affairs Medical Writing

$69,300 - $112,900/Yr

Regeneron Pharmaceuticals - Basking Ridge, NJ

Full-time - Mid Level

Basking Ridge, NJ

Professional, Scientific, and Technical Services

About the position

The Editor in Regulatory Affairs Medical Writing at Regeneron Pharmaceuticals is responsible for performing quality control checks on clinical regulatory documents to ensure compliance with company standards and Health Authority guidelines. This role involves editing various documents, training on document formatting, and collaborating with senior staff on process improvements.

Responsibilities

• Perform high-quality QC checks of medical writing documents such as Submission Modules, Clinical Study Reports (CSRs), and Investigator Brochures (IBs).
• Edit Informed Consent Forms (ICFs) and Protocol Amendments, and as skills improve, edit Protocols and IBs.
• Train on document editing and formatting for Submission Modules and CSRs.
• Work with senior Medical Writing Editors to review and update process improvement projects.
• Compile, verify content, and format appendices for CSRs.
• Ensure adherence to internal standards and procedures.

Requirements

• Bachelor's Degree or Editor of Life Science (ELS) certification.
• 2 years of relevant industry experience in medical writing or editing.
• Technical reading, writing, and editing skills.
• Organizational, interpersonal, and communication skills.
• Working knowledge of Microsoft Word, Adobe Acrobat, and PowerPoint.

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off