Associate Director, Medical Writing

Role Summary

Associate Director, Medical Writing. Remote position. Responsible for the creation, editing, and quality control of scientific, medical and regulatory documents, and for managing interactions with external consultants and CROs.

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 SOPs/Style Guide.
• Manage and coordinate communication with consultants and CROs.
• Other duties as assigned.

Qualifications

• Ph.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 template/toolbars is a plus.
• Scientific and medical curiosity strongly valued.

Skills

• Scientific writing and editing
• Regulatory documentation (clinical protocols, reports, Investigator Brochures, NDA modules)
• Quality control and compliance
• Communication with external vendors (consultants/CROs)
• Attention to detail
• Microsoft Word proficiency

Education

• Ph.D., PharmD, MD/DVM or equivalent in biological sciences preferred

Additional Requirements

• Location: Remote