Medical & Scientific Writer

Terumo Aortic is a leading global medical device company dedicated to advancing medical technology and ensuring regulatory compliance. We are experiencing a time of unprecedented growth and investment, and we invite you to join our dynamic team. We are currently looking for a Medical and Scientific Writer (I) in our Clinical Affairs department, you will play a pivotal role in creating and updating essential clinical documents. You will work within a collaborative environment to ensure the highest standards of quality and compliance with relevant medical device regulations.

**The Key Responsibilities of the role are;**

**Document Creation and Updates**:

- Write and maintain Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post Market Clinical Follow-up Evaluation Reports (PMCFRs), and Summaries of Safety & Clinical Performance (SSCPs) for Class III cardiovascular medical devices.
- Conduct scientific literature reviews, including the preparation of literature search reports.
- Analyse clinical and post-market surveillance data to evaluate the safety and performance and benefit-risk ratio of the device under evaluation.

**Collaboration and Liaison**:

- Work with departments such as Clinical Affairs, R&D, QA, Risk Management, Sales & Marketing, and Regulatory Affairs to gather necessary information for CERs.
- Assist the team in responding to Notified Body/Regulatory Authority queries related to clinical data or the clinical evaluation process.

**Regulatory and Quality Compliance**:

- Stay updated with regulations and guidance documents related to clinical evaluation, PMCF, and SSCPs, and relevant clinical practice guidelines.
- Ensure compliance with internal procedures and Medical Device Regulations (MDR) 2017/745, Medical Device Directive (MDD) 93/42/EEC, relevant MDCG guidance, and MEDDEV 2.7/1 revision 4.

**Additional Responsibilities**:

- Provide clinical data for regulatory submissions and other departmental needs.
- Conduct ad-hoc literature reviews as required.
- Contribute to the review and update of Instructions for Use and Marketing Collateral.
- Assist in maintaining team SOPs and participate in project teams as the Medical & Scientific Writing Team representative.

**Essential**:

- Degree in a relevant discipline (e.g., Life Sciences, Biomedical Engineering).
- Experience in conducting scientific literature reviews.
- Strong analytical and data interpretation skills.
- High attention to detail and accuracy in documentation.
- Excellent communication and time management skills.
- Proficiency in Microsoft Word, Excel, and PowerPoint.

**Desirable**:

- Experience in technical, scientific, or regulatory writing.
- Familiarity with the cardiovascular system and/or the medical device industry.
- Experience analysing clinical data.
- Experience authoring CEPs, CERs, PMCFRs, and SSCPs.
- Familiarity with the MDR and associated MDCG guidance documents.

**Benefits**:

- Additional leave
- Company pension
- Cycle to work scheme
- Discounted or free food
- On-site parking
- Referral programme
- Sick pay

Schedule:

- Day shift
- Monday to Friday

Supplemental pay types:

- Performance bonus

**Education**:

- Bachelor's (preferred)

**Experience**:

- medical writing: 1 year (preferred)

Work Location: Hybrid remote in Renfrew, PA4 9RR