Job Description

In our line of work, life isn\xe2\x80\x99t a given - it\xe2\x80\x99s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we\xe2\x80\x99re located. Creating impactful innovations like ours, doesn\xe2\x80\x99t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career. Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we\xe2\x80\x99re working at the pace of change to improve patient lives with diagnostic tools that address the world\xe2\x80\x99s biggest health challenges. As Radiometer is a company within Danaher, there will also be an opportunity to interact and share information and findings with other Danaher Operating Companies worldwide. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. The Medical Writer Specialist for Radiometer will be responsible for documentation of clinical study reports, investigator\xe2\x80\x99s brochure, and other regulatory documentation such as performance evaluation reports, post-market surveillance report, periodic safety update reports, etc. and will work closely with partners within Clinical & Medical Affairs, as well as within R&D, Regulatory Affairs and Marketing, across Radiometer\'s solutions within blood gas, immunoassay testing and transcutaneous monitoring. This position is part of the Clinical and Medical Affairs located in the India Development Center (IDC) Bangalore, India and will be a hybrid position. You will be a part of the Clinical Surveillance team and report to the team lead for the Medical Writing team located in IDC Bangalore responsible for the medical writing activities. If you thrive in an amazing and challenging role as a medical writer and want to work to build a world-class medical writing documentation\xe2\x80\x94read on. In this role, you will have the opportunity to:

• Work closely with clinical study managers to provide inputs to the clinical study protocol and to develop the investigator\xe2\x80\x99s brochure.
• Collaborate with data managers and biostatisticians for the clinicals study reports.
• Create and update standard operating procedures and associated templates based on regulatory requirements and process improvement requirements.
• Write and update regulatory documents such as periodic safety update reports (PSURs), performance evaluation plans and reports (PEPs and PERs), post-market surveillance plans and reports (PMS plan, PMS reports), etc.

The essential requirements of the job include:

• PhD, ME/Mtech in Engineering (preferrably Biomedical Engineering, Medical Electronics, Biotechnology, or Electronics Engineering with experience in Medical Devices) or MSC/PhD in Biology, Biotechnology, and Microbiology
• 3 to 5 years of medical writing such as CERs, CEPs, PERs, PMS Reports, PSURs, etc.
• Should be familiar with MDR, IVDR, ISO-14155, and ISO-20916.
• Excellent written and Oral Communication in English.
• Should possess the ability to work independently with minimal supervision in a structured way with a quality mindset.

It would be a plus if you also possess previous experience in:

• Previous experience with journal publication writing and thesis writing.
• Experience in writing clinical study reports and investigator\xe2\x80\x99s brochure for medical devices and in vitro diagnostic devices.
• Experience in writing study reports for 510k submission.

Travel

• About 10% including International Travels

At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide. When you join us, you\xe2\x80\x99ll also be joining Danaher\xe2\x80\x99s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you\xe2\x80\x99ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you\xe2\x80\x99ve ever wondered what\xe2\x80\x99s within you, there\xe2\x80\x99s no better time to find out.