Associate Director, Medical Writing

Role Summary

Associate Director, Medical Writing. Remote.

Responsibilities

• Write, review, edit, proofread, verify, and manage Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, NDA clinical modules, and other higher-level regulatory documents.
• Contribute to document templates, style guides, and medical writing related SOPs
• Conduct quality control (QC) checks to ensure accuracy, consistency, and compliance with regulatory requirements and Celcuity SOPs and Style Guide.
• Manage and coordinate communication with consultants and CROs.
• Other duties as assigned.

Qualifications

• D., PharmD, MD/DVM, degree in biological science preferred with a minimum of 5 years of experience in oncology regulatory medical writing (MS with a minimum of 10 years relevant experience).
• 10+ years of experience preferred.
• Exceptional attention to detail.
• Proficiency in Microsoft Word; experience with Accenture Starting Point templates and add-on toolbars is a plus.
• Scientific and medical curiosity strongly valued.