Clinical Evaluation Report (CER) Medical Writer

Fully Remote, Global

We are currently hiring several CER Writers for our US-based Regulatory Writing client. They are an international regulatory and medical writing organisation, committed to empowering companies to deliver better healthcare solutions. If you are interested in applying your regulatory writing expertise to a variety of regulatory writing projects with top industry clients, this may be the opportunity for you.

The main scope of this role is to provide regulatory writing expertise for the development of initial and annual update CER’s that support the overall global regulatory submission requirements for the client’s portfolio of medical device products.

Some main aspects of the role will include:

• Prepare regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs)
• Combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745.
• Perform routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical devices
• Perform critical review and data analysis from clinical investigations and literature for incorporation into the CER
• Serve as the regulatory writer on assigned CER projects, collaborating with the CE Scientific Quality Manager to meet all project deliverable timelines
• Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates

Ideally candidates will have experience in following areas:

• Previous experience writing CERs and related documents in accordance with MEDDEV 2.7/1 rev 3 and 4
• Effective written, verbal and presentation skills in the area of technical/clinical applications
• Strong command of medical and surgical terminology
• Demonstrated ability to identify and adapt to shifting priorities and competing demands
• Proficiency in document development and management using Word, Excel, PowerPoint and EndNote

If you have experience writing CERs and related documents, we’d be interested in hearing from you. Apply with your CV now, and feel free to contact Tom Kirkpatrick at Semper Search for more information on 07851 246 849.