- Entry level
- No Education
- Salary to negotiate
In your role as a (senior) medical writer in the Medical Affairs team, you will be responsible for the planning, preparation, update and maintenance of Clinical Evaluation Reports and Post-Market Surveillance plans. You will act as the scientific, technical and project management coordinator between the R&D project leaders, and internal and external Medical Experts.
Your task will be to:
- Define systematic literature search protocols and perform comprehensive literature searches to collect and summarize published clinical data, and to review the clinical State of the Art on the different product and indications.
- Write comprehensive scientific State of the Art reviews, using you academic and/or research experience to master and summarize and highly specialized and complex subject matters.
- Act as the dedicated Point of Contact to the Development project teams. Gather and compile necessary project information for the Medical Experts, and communicate planning relevant information to and from the project teams.
- Maintain and develop scientific literature management databases.
- Define complex data and statistical analysis processes and execute on them.
- Integrate and assemble all relevant clinical and literature data, and draft the Clinical Evaluation Reports for the Medical Expert to review and complete.With the Medical Experts, help to define, plan, and initiate clinical studies and in vitro tests together with all stakeholders from Clinical Research, R&D, Biomechanics and Regulatory Experience, Education & Knowledge:
- This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
- Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.
- Job requires an understanding and application of procedures and concepts of own discipline.
- The job requires the ability to make judgments based on practice and previous experience.
- This job typically requires a degree or equivalent and no experience. Work From Home: OccasionalTravel Percentage: 10%
- ms project