Terumo Aortic are currently looking to recruit a Medical & Scientific Writer on a fixed-term basis to join our team. This is an excellent opportunity where you will create and update Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post Market Clinical Follow-up Evaluation Reports (PMCFRs) and Summaries of Safety & Clinical Performance (SSCPs) to ensure regulatory compliance.

The main responsibilities of the role are;

• Write, contribute to and manage the review/approval of the following documents within the required timeframes and in accordance with  internal procedures,  Medical Device Regulations 2017/745 (MDR), Medical Device Directive 93/42/EEC (MDD), relevant MDCG guidance and MEDDEV 2.7/1 revision 4:
  • CEPs
  • CERs, including the following tasks:
    • Conduct scientific literature reviews and complete literature search report
    • Identify, appraise and analyse pertinent data
    • Evaluate the intended clinical benefits (including marketing claims) and safety and performance objectives

• PMCFRs
• SSCPs
• Liaise with other departments to obtain information required to complete/update CERs, including R&D, QA/Risk, Sales & Marketing and Regulatory Affairs
• Collaborate with the team on responses to Notified Body/Regulatory Authority questions relating to clinical data or the clinical evaluation process
• Provide clinical data when requested from other departments including for regulatory submissions
• Conduct ad-hoc literature reviews, as required
• Provide input into Instructions for Use and Marketing Collateral updates (including reviewing marketing claims)
• Assist with the maintenance of Medical & Scientific Writing Team procedures
• Serve as the Medical & Scientific Writing Team representative on assigned project teams
• Keep up to date with relevant regulations and associated guidance documents related to clinical evaluations, PMCF and SSCPs
• Keep up to date with the state of the art including benchmark devices and relevant clinical practice guidelines/recommendations
• Assist with training of new team members

The successful candidate will possess;

Essential:

• Qualified to degree level or above in a relevant discipline (e.g. Life Sciences, Biomedical Engineering)
• Experience in authoring CEPs, CERs, PMCFRs and SSCPs
• Understanding of and experience with the relevant regulations e.g. MDR and associated MDCG guidance documents
• Experience conducting scientific literature reviews
• Experience in technical/scientific/regulatory writing
• Proven time management skills
• Proven experience in using Microsoft Word, Excel and PowerPoint

Desirable:

• Understanding of medical statistics
• Experience mentoring junior colleagues