Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?
Then come and join our global team as
Clinical Affairs Scientist - (M/F)
to organize, maintain and expand internal and external clinical performance evaluation studies with clinical investigators assay development.
Your main tasks and responsibilities:
• You will organize, maintain and expand internal and external clinical performance evaluation studies with clinical investigators;
• You will develop and maintain relationships with opinion leaders (KOL);
• You will obtain necessary clinical sample material for development and manage product verification studies;
• You will ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications;
• You will be in charge of project management and will action as interim person between different departments;
• You will develop and sustain Post-Market-Surveillance-system;
• You will be involved in risk management;
• You will ensure the development of relevant documentation (SOP, process instructions, instructions of use, performance evaluation reports, etc…);
• You will ensure adherence to protocols and compliance with regulatory (IVDR, IVDD, ICH, GHTF, FDA…) guidelines;
• You will compile and review performance evaluation reports, educational material for users, marketing material, etc…
• You will develop, maintain and expand collaborations with outside clinical investigators, researchers and thought leaders to facilitate the optimum performance of clinical development programs;
• You will develop educational articles/news;
• You will search for brand related publications;
• Travel activity can take up to 10-20% if required.
To find out more about the specific business, have a look at https://www.siemens-healthineers.com/molecular-diagnostics
Your qualifications and experience:
- Master or PhD as Biologist /Chemist or Biochemist
- Experience with Real time PCR is considered a plus
- Experience in life sciences industry will be an advantage
- Experience in Clinical Affairs is required
Your attributes and skills:
- You are a driven individual with a history of developing collaborative, cross-functional solutions
- You have highly developed writing and interpersonal skills with the ability to work on diverse teams
- You have a professional working knowledge of common software packages (Word, PowerPoint, Excel)
- You have excellent written and spoken English language skills
- You have capacity for working independently and excellent interpersonal and organizational skills
Our global team:
Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.
Organization: Siemens Healthineers
Company: FAST TRACK DIAGNOSTICS LUXEMBOURG S.à r.l.
Experience Level: Experienced Professional
Job Type: Full-time