Ärztliche Unterstützung / Medical Advisor (m/w/d)
Core
Medical Advisor supporting Clinical Operations and Therapy with medical expertise in planning, conducting, evaluating, and documenting clinical studies, and addressing medical-regulatory questions.
Role type
Senior Medical Advisor (Clinical Operations)
Builds
Clinical study designs, medical reviews of study protocols and data, regulatory submissions, and medical device purpose definitions.
Domain
Medical Devices / DiGA (Digital Health Applications) / Clinical Research
Required skills
Medical judgment, structured preparation of medical facts for interdisciplinary teams, clinical experience in physician care, regulatory understanding (MDR EU 2017/745, GCP, ISO 14155, ISO 13485), medical writing/review capabilities
Preferred skills
Specialist in Orthopedics and Trauma Surgery or Physical and Rehabilitative Medicine, experience in clinical studies (medical devices/DiGA), regulatory process experience, literature research and evidence evaluation, English for scientific reviews
Technologies
MS Office
Responsibilities
Conduct medical reviews of study protocols and data using the 4-eyes principle; support development and medical evaluation of clinical study designs; assist in regulatory submissions and ethics applications; evaluate SAEs and protocol deviations; review medical statements in study materials; participate in meetings with external consultants and regulatory stakeholders.
Seniority
Senior, hands-on IC