mySugr GmbH
Healthcare
ClinicalEvaluationManager-Freelancer
Neural analysis suggests this role is
optimal for Manager candidates.
“Clinical Evaluation Manager - Freelancer at mySugr GmbH. Skills: Clinical evaluation, CER writing, Risk management. Lead end-to-end clinical evaluation activities. Author regulatory-compliant Clinical Evaluation Reports (CERs)”
Industry & Context.
Analytical skills; Problem-solving skills; Risk-based decisions
What They're Looking For.
Must Have
1-3 years regulatory/CER writing, Advanced degree in medicine, life sciences, pharmacology, biomedical engineering, biostatistics/epidemiology or related fields, Analytical and problem-solving skills, Excellent written and verbal communication skills in English, Detail-oriented with ability to manage multiple tasks and deadlines, Capability to make risk-based decisions, Basic understanding of clinical research and biostatistics, Proficiency in Google Workspace, Ability to work independently and as part of a team, Eagerness to learn and contribute
Nice to Have
Technical understanding of innovative apps/software development, Medical background, Knowledge of diabetes industry or similar health industries, Knowledge of SAFe Agile ways of working, Confident speaking in front of others
What You'll Do.
Lead end-to-end clinical evaluation activities
Author regulatory-compliant Clinical Evaluation Reports (CERs)
Demonstrate device safety and performance
Provide expert medical input to medical risk management
Provide expert medical input to vigilance
Facilitate team backlog grooming
Facilitate prioritisation of deliverables
scalable working practices
How You'll Work.
Team & Collaboration
Part of a team
Communication Scope
Written communication; Verbal communication
Process & Methodology
Backlog grooming, Prioritisation
Full Job Description
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_](https://www.youtube.com/watch?v=ERe3FE45vDk&t=1s) to see how we at Roche are making personalized health care a reality. The [_mySugr GmbH_](https://www.mysugr.com/en/about-us) 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_](https://www.mysugr.com/en/about-us). ### **Here 's what we're looking for:** _Freelancer (20hrs per week)_ We are looking for a freelance****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:**** * **Experience:** * 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 r
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