Senior Medical & Scientific Writer

Terumo Aortic

Inchinnan, United Kingdom

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.