PRINCIPAL DUTIES AND RESPONSIBILITIES: 

Authorship of CERs and related documents in close alignment with the director of the respective therapy field Supportive function in risk management, in particular concerning medico-regulatory topics: Provide support in the development, maintenance and updating of documents related to risk management deliverables Participation in cross-functional teams for medical-regulatory aspects Authorship of assessments concerning product development issues, in analysis of clinical data and in defining the medical evidence needed for driving or improving product development processes in close collaboration with the therapy field director Planning and support of medico-scientific activities related to generation of clinical evidence (studies) in close alignment with the respective director and Clinical Research