Job Description

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Compilation and update of drug dossiers with focus on the clinical part in close alignment with the therapy field director
• Provide answers to authorities on registration related medical/pharmacological questions in close alignment with the director of the respective therapy field and with drug regulatory
• Support of drug development projects
• Participation in audits: support of therapy field leader with respect to therapy field relevant documents
• 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
• Assessment of potentially relevant Literature within the frame of the literature vigilance process

EDUCATION

University degree in Medicine, Pharmacy, natural science, medical engineering or related science

EXPERIENCE AND REQUIRED SKILLS

• At least 5 years of Regulatory Medical writing work experience, preferably in a comparable position within health care or pharmaceutic or medical technology companies or research institutions
• Knowledge of relevant regulations for drugs
• Competence in the direct compilation of medical and scientific documents, and in the coordination and collection of contributions from various people/departments
• Experience in conducting systemic and process-oriented searches in medical and scientific databases
• Familiarity with relevant products and topics in the field of dialysis / nephrology (nice to have)