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Clinical Scientist/Medical Writer in Brønshøj, Denmark at Radiometer

Date Posted: 3/26/2019

Job Snapshot

Job Description

Job ID: MED001726

About Us

At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives.
On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.
Want to know more about our mission and vision? Click on the link: Link of YouTube video
Our people
At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3200 colleagues are committed and dedicated to help realize life’s potential.

If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you.


Description

Do you have a passion for analyzing scientific publications and compiling clinical data using your medical writing skills and do you like the thought of communicating cross-functionally in the HQ for a market leading medical device and in vitro diagnostic company? Then this might be your new career opportunity.
In Radiometer Medical you can use your experience in writing Clinical Evaluation Reports (CERs) for medical devices and Performance Evaluation Reports (PERs) for in vitro diagnostic medical devices to ensure our mission of helping caregivers make diagnostic decisions that save lives. 
To be able to meet the increasing regulatory requirements on time and in correct manner, we are expanding our Clinical Affairs department by 2 positions. As Clinical Scientist, you will become part of a team with whom you will work closely to ensure that the clinical evaluations and performance evaluations are in compliance with the new guidelines and regulations within medical devices and in vitro diagnostic medical devices.
 
Your primary responsibilities will be:
• Write CERs and PERs based on systematic literature review as well as being responsible for data collection, data appraisal, and data extraction from safety and performance data related to our products
• Conduct systematic literature searches on Radiometer’s products and product families. Identify equivalent comparator and competitor products. Review and appraise published literature to identify articles applicable to safety and performance of Radiometers products
• Bring together stakeholders from R&D, Marketing, Regulatory Affairs, Clinical Operations, and Clinical Affairs who pose information needed for the CERs and PERs and coordinate the collaboration in the generation of the reports
• Understand regulatory submissions and priorities while compiling pre-clinical data incl. clinical investigation protocol and clinical study reports 
• Proactively plan and manage project risks, provide input to appropriate counter-measures and contingency plans and assure implementation of action plans to reduce project risk
The job requires travelling up to 15% of your time.
Contribute, grow and develop
Radiometer is a growing organization always developing through LEAN management tools and values. It makes it fun and meaningful to be part of an organization where your thoughts and ideas are embraced by management and can make a true impact. Developing on a personal and professional level is of a high importance for everyone in Radiometer and that is why we have many employees building and developing their careers for many years in Radiometer and Danaher.
Application deadline
Application deadline is Tuesday 23 April, 2019. Please start the application process as soon as possible by pressing "Apply Online". Please attach your CV and other relevant documents. We look forward to receiving your application.
For further information, please contact Hiring Manager, Sanne Lauemøller at tel. +45 38272263 or Recruiter, Peter Høgh, Peter.hoegh@radiometer.dk

Job Requirements



Qualifications

A scientific, biological or medical science background increases your chances of success combined with most of the following qualifications:

• >2 years of experience in writing CERs preferably from the Medical Device Industry

• Excellent in reading; evaluating and appraising scientific literature related to a device

• Possess knowledge about the required documentation during medical device development process and understand how to apply medical writing skills to create CERs and PERs

• Possess knowledge within Immuno Assays

• Proven record of collaborating with stakeholder and use your experience to assure that the level of clinical documentation is proportional with the risk classification for the device

• Demonstrated strong ability to understand complex scientific, engineering and business concepts

• Possess knowledge about the regulations (e.g. EU Regulation 2017/745 and EU Regulations 2017/746), guidelines and ISO standards applicable to clinical evaluation for medical devices and performance evaluation for IVD-devices.



Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.