Clinical Evaluation Manager - Freelancer (20hrs per week)(m/f/d)
About this role
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:
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?
- We are committed to providing a healthy, equal and inclusive working environment for our employees to bring true relief to the patient! We care about family friendly career paths, sustainability, a healthy lifestyle and the flexibility of a modern workplace. We maintain a culture of learning and sharing, as well as open and candid feedback. At every level, there are many opportunities to develop and grow - both professionally and personally.
- As a healthcare pioneer committed to transforming the lives of billions of people around the globe, we push boundaries to redefine what is possible. We know that early, accurate diagnosis is essential to maintain health, prevent disease and help advance new, targeted treatments and potential cures for the world’s most serious health problems. We have a passion for innovation and a profound commitment to make a lasting impact on society by continuing to improve the standard of care for humankind. Our culture inspires us to create healthcare that is sustainable, efficient and financially viable. Healthcare that is built on people’s needs, strong data and clinical insights. Healthcare that saves lives.
- 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.