Job
In this role, you support the R&D team in analytical and clinical product evaluation and data analysis by preparing evaluation protocols, reports, and applying statistical tools for performance data.
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Your role in the team
- Support the R&D team in analytical and clinical performance evaluation of products and stability studies and their data analysis and documentation by:
- Preparation of analytical evaluation protocols
- Data evaluation (internal/external performance data) by using statistical tools
- Preparation of performance study reports
- Support the Post-marked Performance Follow-up process
- Support the creation of templates for Clinical Evidence requirements
- Drive projects across various global Sebia sites and work with external collaboration partner
Our expectations of you
Education
- Master's degree in biology, biotechnology, biochemistry, or similar; advanced graduate degree (PhD) is a plus
Qualifications
- Strong analytical and strong quality management thinking
- Interest and understanding of the regulatory landscape (IVDR, ISO, CLSI, 21CFR)
- Understanding of complex performance data with excellent data presentation skills
- Enjoy working in a team
- Careful, accurate and responsible way of working
- Good documentation practice
- Confident in the use of MS Office
- Fluent in English, German is a plus
Experience
- Experience in technical and scientific writing for regulatory audiences such as Notified Bodies, FDA or other authorities is a plus.
- Experience in statistical tools for data analysis, especially Excel, additional tools are a plus
What we offer
- Fixed-term employment contract
- A crisis-proof job with an attractive income
- Annual salary review
- Flexible working hours
- Individualised employee development and training
- Attractive package of health and social benefits (e.g., subsidised computer glasses, flu vaccination, employer contribution of 30% to private pension scheme)
- Employer subsidy for the canteen, free drinks
- Crèche and kindergarten allowance (max. €200)
- Employee discounts with well-known brands
- Anniversary bonus
- Car park directly at the company
Benefits
Work-Life-Integration
Topics you will work on
Job locations
About your employer
Founded in 1988 in Mainz, Orgentec Diagnostika GmbH is a leading company in laboratory diagnostics, developing and distributing innovative test systems for autoimmune diagnostics and infection serology.
- Established Company
- Onsite
- Healthcare, Social Sector
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