Current jobs related to Medical Writer - Renfrew - Terumo Aortic

**_Terumo Aortic have an exciting new role for a Medical Writer to join our talented and experienced team. This is a fantastic opportunity for someone to join the team and be able to add real value whilst continue to grow their career. _**

**_The main objectives 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
- 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

**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

**Benefits**:

- Additional leave
- Casual dress
- Company events
- Company pension
- Cycle to work scheme
- Discounted or free food
- Free parking
- On-site parking
- Referral programme
- Sick pay
- Work from home

Schedule:

- Monday to Friday

Supplemental pay types:

- Bonus scheme

Work Location: Hybrid remote in Renfrew