Lead, Evidence Analysis, Evaluation & Communications – ENT
Smith+Nephew
full-time
Posted on:
Location Type: Hybrid
Location: Hull • 🇬🇧 United Kingdom
Visit company websiteJob Level
Senior
About the role
- Lead the development of Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), and Summary of Safety and Clinical Performance (SSCPs) in compliance with EU MDR and global standards
- Conduct systematic literature reviews and data extraction to support clinical evaluations and regulatory submissions
- Act as subject matter expert during audits and regulatory reviews, providing strategic input and supporting new product development decisions
- Perform critical appraisal and synthesis of clinical and scientific data to support product claims and strategic decision-making
- Manage product claims and ensure alignment with clinical evidence and regulatory standards
- Translate complex data into accessible formats such as infographics, summaries, and training materials
- Develop and lead evidence communication strategies for priority brands
- Collaborate with internal teams and external partners to ensure alignment with business strategy and regulatory requirements
Requirements
- Minimum of 5 years’ commercial experience in medical device or pharmaceutical sectors, or 8 years combined academic and industry experience
- Proven ability to conduct literature reviews and analyze clinical and scientific data
- Expertise in authoring regulatory documents aligned with EU MDR and related frameworks
- Experience developing promotional and educational materials aligned with clinical evidence and strategy
- Strong scientific writing, data analysis, and project management skills
- Degree in biomedical sciences or clinical discipline (PhD preferred)
Benefits
- Generous annual bonus and pension schemes
- Save As You Earn share options
- Flexible vacation and time off
- Paid holidays and paid volunteering hours
- Private health and dental plans
- Healthcare cash plans
- Income protection
- Life assurance
- Discounts on gyms and fitness clubs
- Salary sacrifice bicycle and car schemes
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Clinical Evaluation Reports (CERs)Clinical Evaluation Plans (CEPs)Summary of Safety and Clinical Performance (SSCPs)systematic literature reviewsdata extractionregulatory submissionsscientific writingdata analysisproject managementauthoring regulatory documents
Soft skills
strategic inputcritical appraisalsynthesis of datacommunication strategiescollaborationalignment with business strategyalignment with regulatory requirements
Certifications
PhD in biomedical sciencesdegree in clinical discipline