Associate Director, Medical Writing
Celcuity
Full-time
Remote
United States
$200,000 - $230,000 USD yearly
Clinical Research and Development
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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.