Smith & Nephew
Description
This position works closely with internal partners including Global Clinical Research Operations (GCRO), Global Data Analytics, Evidence Evaluation (EE), Evidence Analysis (EA), Regulatory Affairs, Health Economics/Outcomes Research, Global Marketing and Biologic Sales Teams. Externally, this position works closely with health care practitioners, consultants and vendors to drive evidence generation activities.
What will you be doing?
- NPD (10%) – Serve or assist on new product development teams for Sports Medicine Biologics and provide clinical support for required regulatory submissions. This includes liaising with cross-functional teams (i.e., EE, EA, Regulatory) to assess evidence needs and ensure timely evidence strategy execution.
- Secure/Maintain Access (40%) – Perform robust and objective review of clinical and scientific data to support product maintenance for EU MDR requirements in relation to PMCF plans and PSURs. This includes relevant study oversight, on time delivery of relevant study milestones, and the generation of clinical activity reports, if applicable.
- Support Market Adoption (50%) – Manage evidence generation opportunities from clinical project approval to evidence activation (i.e. Sponsor Initiated Studies, Investigator Initiated Studies, Data Collection Agreements) to support the evidence needs as part of the business priorities. This includes building strong working relationship within Global Clinical and Medical Affair Teams, Global Marketing and other business functions to support identification, evaluation and communication of data and evidence to support health care professional evidence-based decision making. Managing multiple projects and adapting to changing needs of the business and stake holders.
What will you need to be successful?
- Education: BS in engineering, or Life Sciences with 4+ years of experience. MS in engineering or life sciences in a related field + 2 years or PhD in engineering or life sciences in a related field.
- Experience: 2+ years of experience conducting or designing clinical research.
- Experience in sports medicine or orthopedics would be advantageous.
- Experience in developing and implementing clinical evidence strategies to support regulatory approvals in various markets is preferred.
- Knowledge and experience in the critical appraisal of published literature, as well as development of manuscripts for peer-reviewed journals.
- Travel Requirements: up to 10% domestic and or international.
