Senior Device Information Scientist
CurrentKey skills, tasks, and responsibilities:* Data and Information Scientist, working with multiple scientific and clinical databases, text mining platforms, and search engines.* Author of state-of-the-art Literature Search Protocols, Clinical Literature Reviews and Reports for Clinical Evaluation Reports (CER), for the entire Novo Nordisk medical device portfolio. Particularly: - Strategic planning of the deliverables and stakeholders. - Identify and define the clinical area for the state-of-the-art/ current knowledge. - Establish a non-biased, systematic search strategy for literature search protocols. - Selection, analysis and appraisal of clinical data.* Internal CER reviewer, focusing on clinical evidence, and clinical data through the entire document. * Process development: achieved and maintain MDR compliance of Literature Search Protocols and Clinical Literature Reviews and Reports.* Analysis and assessment of regulatory documents, guidelines and requirements such as MDR REGULATION (EU) 2017/745, MEDDEV 2.7/1 revision 4, IMDRF MDCE WG/N56FINAL:2019, MDCG-2019-9, MDCG 2020-1, -5, -6 & -13. ISO standards and more.* Briefing clinical and scientific data to Medical Doctors, Project Managers, Risk Managers and/or Researchers.* Business development activities as a team member of the Cell Therapy Innovation Team.