Senior Clinical Scientist / Senior Medical Writer-MED001862

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 3800 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. DescriptionDo you have a passion for analyzing scientific publications, using your medical writing skills and do you like the thought of communicating cross-functionally in the HQ for a market leading Medical Device company? Then this might be your new career opportunity.
In Radiometer Medical you can use your experience in writing Clinical Evaluation Reports to ensure our mission of helping caregivers make diagnostic decisions that save lives.

Lead creation of Clinical Evaluation Reports in Radiometer

You join our Clinical and Medical Affairs Team in an exciting period where we are expanding to meet the regulatory requirements for our broad and technologically diverse product portfolio. You can look forward to proactively lead the creation of Clinical Evaluationi Reports and Performance Evaluation Reports for the different product areas throughout the product lifecycle, and proactively communicate with relevant internal and external stakeholder on a global level.
Organizationally the role is part of our Clinical & Medical Affairs team with reporting line to the Director, Clinical Surveillance.

Implement the processes for Clinical Evaluations

Our available position is an addition to our Clinical Compliance and Surveillance team, which means that you play a key role in defining how you work with the following responsibilities. You:
• Write Clinical Evaluation Reports and Performance Evaluation Reports 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
• Write post market clinical follow-up (PMCF) reports according to applicable guidelines and legal regulations
• Bring together stakeholders from R&D, Marketing, Regulatory Affairs and Clinical who poses information needed for the evaluation reports and coordinate the collaboration in the generation of the reports
• Collaborate cross functional together with post market surveillance team in order to write the PMCF reports
• Are involved in the early development phase in project groups to ensure focus on the documentation of clinical evidence
• Implement and update standard operating procedure for generation of evaluations reports and PMCF in adherence with current legislation (MDR/IVDR)
• Accountable for ensuring the best quality of scientific posters and publications
• 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
• Remain current in clinical evidence regulatory requirements for all applicable countries Write post market clinical follow-up (PMCF) reports according to applicable guidelines and legal regulations
The job requires travelling between 10-20 % 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 22. November 2019, but we will interview as soon as we identify relevant candidates. 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 Senior Recruiter, Peter Høgh, [email protected].

Qualifications

We believe that a scientific, biological or medical science background increases your chances of success combined with most of the following qualifications:
• 5 years of experience in writing Clinical Evaluation Reports and Performance Evaluation Reports 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 outstanding Evaluation Reports and PMCF reports
• 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
You can look forward to using your abilities to structure and organize when you plan the time line for clinical evidence. Thinking strategically and using your communicative skills is relevant when you translate regulatory clinical evidence demands to your collaboration partners in eg. R&D, Marketing or Regulatory Affairs.

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, 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.

Organization: Radiometer
Job Function: Science
Primary Location: EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj
Schedule: Full-time

Kilde: Jobnet.dk