Evidence Evaluation Specialist Jobs

Role Overview:
The purpose of this role is to use medical writing and literature review experience to generate Clinical Evaluation Reports (CERs) and other associated clinical documents such as the Summary of Safety and Clinical Performance (SSCP) and Clinical Evaluation Plan (CEP), in accordance with the appropriate regulatory standards to ensure continued CE registration of Smith + Nephew products.
Responsibilities:

• Works with internal teams to gain cross-functional inputs and approvals into evidence evaluation documentation activities
• Support the registration of products in non-EU countries
• Support the periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives.
• Leads completion of clinical evaluation reports (CERs), SSCPs, CEP, for CE registration including guidance to less experienced team members
• Generates and maintain reference databases

Location: Andover, MA, Memphis TN, Field (US); Hull, Field (UK)
Education: Bachelors in a relevant field required. Master's degree or PhD preferred.
Experience:

• Preferably experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
• Experience in presenting scientific/clinical evidence in a written and oral manner to cross-discipline teams.
• Experience in writing scientific documents for regulatory or journal submissions
• Proven experience of performing literature reviews, analyzing data sets, and communicating the outputs.
• Minimum of 3 years' commercial experience or 5 years' academic and commercial combined.

Competencies:

• Must exhibit high quality, ethical and compliant work habits.
• Self-motivated and able to work independently.
• Strong data extraction and analysis skills.
• Communicates difficult concepts to inform and guide wider business.
• Good communicator and able to work collaboratively as part of a team.
• Experience in reference management software.
• Excellent scientific writing skills.
• Experience in using Microsoft Word, Excel, PowerPoint.
• Excellent time management skills and ability to work under pressure to deadlines.

Physical Demands: Sitting in front of a computer 90%+ of day
Travel Requirements: <10%
If filled in US, the anticipated compensation range for this position is 95K-105K USD annually and the compensation offered will depend on the candidate’s qualifications. You may also be entitled to receive bonus and benefits, which may include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings.
Smith & Nephew follows the Pay Transparency and non-discrimination provisions described by the Colorado Department of Labor and Employment (CDLE).
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.