Celcuity
Biotechnology • Pharmaceuticals
Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.
Associate Director, Medical Writing
November 9
Celcuity
Biotechnology • Pharmaceuticals
Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.
đź“‹ Description
• 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
• medical, dental, vision insurance • 401(k) match • PTO • paid holidays • annual performance incentive bonus • new hire equity package
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