Expert Medical Systems Products Drugs
Core
Compiling and updating drug dossiers with a focus on clinical data, providing answers to regulatory authorities on medical/pharmacological questions, and supporting drug development projects.
Role type
Senior Regulatory Medical Writer (Drugs)
Builds
Drug dossiers and regulatory documentation for kidney care products
Domain
Healthcare / Pharmaceuticals / Nephrology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory medical writing, knowledge of drug regulations, compilation of medical/scientific documents, coordination of cross-functional contributions, systematic literature searches, analysis of clinical data
Preferred skills
Familiarity with dialysis/nephrology products, risk management documentation, planning of medico-scientific studies
Technologies
Medical and scientific databases
Responsibilities
Compile and update drug dossiers focusing on clinical parts; Provide answers to authorities on registration-related medical/pharmacological questions; Support drug development projects; Participate in audits and risk management; Author assessments on product development issues; Plan and support medico-scientific activities for clinical evidence generation; Assess relevant literature for vigilance processes
Seniority
Senior, hands-on IC
