Expert Medical Systems Products Drugs
Core
Compiling and updating drug dossiers with a focus on the clinical part, providing answers to authorities on registration-related medical/pharmacological questions, and supporting drug development projects.
Role type
Senior Regulatory Medical Writer (Drugs)
Builds
Drug dossiers and medical evidence for product development
Domain
Healthcare / Pharmaceuticals / Nephrology
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, planning of medico-scientific activities
Preferred skills
Familiarity with dialysis/nephrology products, analytical intellectual capacity, inter-cultural competence
Technologies
Medical and scientific databases
Responsibilities
Compilation and update of drug dossiers with focus on the clinical part; Provide answers to authorities on registration related medical/pharmacological questions; Support of drug development projects; Participation in audits; Supportive function in risk management regarding medico-regulatory topics; Participation in cross-functional teams for medical-regulatory aspects; Authorship of assessments concerning product development issues; Planning and support of medico-scientific activities related to generation of clinical evidence; Assessment of potentially relevant Literature within the frame of the literature vigilance process
