Medical Writer - PhD - Hematology/Oncology - Cincinnati
Core
Lead development of high-quality clinical and regulatory documents to support the safe and effective development of medical therapeutics.
Role type
Senior Medical Writer (Hematology/Oncology)
Builds
Clinical study reports, protocols, Investigator's brochures, IND and NDA modules
Domain
Biotechnology / Pharmaceutical / Clinical Research
Required skills
PhD in Life Sciences, Hematology research, Oncology research, Clinical document writing, Regulatory document writing, Quality control reviews, Cross-functional collaboration, Project management
Preferred skills
CRO experience, Pharmaceutical industry experience, Medical writing industry experience
Technologies
Clinical study reports, protocols, Investigator's brochures, IND, NDA modules
Responsibilities
Write, edit, and maintain complex clinical and regulatory documents; Coordinate and conduct quality control reviews; Collaborate with Sponsors and subject matter experts; Manage multiple projects and tasks simultaneously; Maintain compliance with company processes and industry guidelines
Seniority
Senior, hands-on IC