Clinical Evaluation Manager - Freelancer (20hrs per week)(m/f/d)
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Requirements
- 1-3 years of experience with regulatory/CER writing for medical devices or in vitro diagnostics
- Education:
- Advanced degree (e.g., MSc, PhD, MD, PharmD, etc) in medicine, life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology or other related fields
- Skills and Competencies:
- Strong analytical and problem-solving skills
- Excellent written and verbal communication skills in English
- Detail-oriented with the ability to manage multiple tasks and deadlines
- Capability to make risk-based decisions
- Technical Proficiency:
- Basic understanding of clinical research and biostatistics
- Proficiency in Google Workspace
- Personal Attributes:
- Ability to work independently and as part of a team in an open, collaborative way
- Eagerness to learn and contribute to the achievement of the team and the company
- Bonus skills:
- Technical understanding and love for innovative apps and/or software development
- Medical background and/or knowledge of the diabetes industry or other similar health industries
- Knowledge of SAFe Agile ways of working
- Confident speaking in front of others
- Who we are and what we care about?
- Interested? Great. We'd like to hear from you! Just click that "Apply Now" button and send us your CV in English .... and anything else that you think might impress us.
- Roche is an Equal Opportunity Employer.
Benefits
Additional Information
Let's build a healthier future, together! By combining our unique strengths, we are redefining healthcare through sustainable action and innovation. For a behind-the-scenes look, check out this video to see how we at Roche are making personalized health care a reality. The mySugr GmbH was acquired by Roche in 2017 and our Vienna office is one of Roche's global sites. You will be located here, in the heart of Vienna, no matter if you work on a mySugr®, Accu-Chek®, navify® or any other Roche product or solution. You can read more about the history of mySugr & Roche here . Here's what we're looking for: Freelancer (20hrs per week) We are looking for a f reelance Clinical Evaluation Manager who will lead end-to-end clinical evaluation activities for mySugr/Roche products, including systematic literature reviews, data appraisal, and the authoring of regulatory-compliant Clinical Evaluation Reports (CERs) to demonstrate device safety and performance. You will provide expert medical input to medical risk management and vigilance across the full product lifecycle, from development to post-market. Additionally, you will be responsible for facilitating team backlog grooming and prioritisation of deliverables to ensure efficient, scalable working practises. Essential skills for your mission:
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