Medical Writer - PhD - Cardiovascular/Metabolic - 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 (PhD)
Builds
Clinical study reports, protocols, Investigator's brochures, IND and NDA modules
Domain
Pharmaceutical / Clinical Research / Cardiovascular & Metabolic
Required skills
PhD in Life Sciences, Cardiovascular research expertise, Metabolic research expertise, Clinical document synthesis, Regulatory document writing, Quality control review, Project management
Preferred skills
CRO experience, Pharmaceutical industry experience, Medical writing 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