The client offers high-quality medical writing and editing services to multinational pharmaceutical and medical device companies, clinical research organizations, and researchers worldwide. They work with over 25 clients located in the UK, US, EU, and APAC and require a highly experienced candidate to act as a subject matter expert in respect of medical devices. Managing the team of in house CER writers and training new additions to the team, to provide medical device clients with clinical publication, regulatory writing, medical communications and clinical evaluation reports.
- Provide expertise in clinical evaluation reports – particularly (MedDEV 2.7/1 Rev 4)
- Participate in client pitches and in organic and new business development activities
- Manage and develop the existing team of CER writers and be responsible for reviewing their work and overall accountability for documents delivered to the client
- Participate in leadership activities, including developing white papers and facilitating advisory board/panel meetings at industry conferences
Working for this world class agency will present exposure to the largest clients within the medical device sector, working to ensure approval for the most innovative and creative healthcare solutions. In return you will benefit from a supportive culture and the opportunity to grow and develop both professionally and personally. The role also comes with an extensive benefits package and a strong policy of recognition and reward for hard work and success.
- MD or PhD in a relevant field, with 8-10 years of overall experience in clinical development/regulatory affairs for medical devices
- Deep domain expertise in clinical evaluation of medical devices and thorough understanding of MDR and MedDEV 2.7.1 Rev 4 guidelines
- 4-5 years of experience in the development of Clinical Evaluation Reports for all classes of medical devices in a CRO or medical device company setting; experience of working with cross-functional CER review teams in sponsor company
- Experience of working with Notified Body auditors and medical device regulators will be an added advantage
- Excellent literature evaluation and summarization skills; familiar with literature search tools, literature databases, EndNote, etc.
- Critical thinker
- People management experience
- Wiling to travel to client meetings or to office locations globally when needed
This opportunity will not be around for long, if this role is of interest to you please apply without delay!