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:
1. 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:
2. CEPs
3. 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 conducting scientific literature reviews
* Experience in technical/scientific/regulatory writing
* Proven time management skills
* Proven experience in using Microsoft Word, Excel and PowerPoint
Desirable
* Experience in authoring CEPs, CERs, PMCFRs and SSCPs
* Understanding of and experience with the relevant regulations e.g. MDR and associated MDCG guidance documents
* Understanding of medical statistics
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