Associate Director, Medical Writing - Remote

Overview

We are seeking an Associate Director, Medical Writing who will report into the Executive Director of Clinical Science. You will be responsible for the creation, editing, and quality control of scientific, medical and regulatory documents. This role will also involve managing interactions with external consultants and clinical research organizations (CROs).

In Short

• 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.

Requirements

• 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.

Benefits

• Annual performance incentive bonus.
• New hire equity package.
• Medical, dental, vision insurance.
• 401(k) match.
• PTO and paid holidays.