Evidence Evaluation Specialist

Job description

SUMMARY

The Evidence Evaluation Project Manager (EEPM) is responsible for providing scientific support to both internal and external customers, including advisory boards, governing bodies, marketing, quality assurance, regulatory and clinical affairs, research and development, and legal. The EEPM supports any core Scientific Affairs objectives. The EEPM works with other department personnel to develop and maintain strong relationships with leading external content experts to critically evaluate and generate medical and scientific evidence, supporting the organizations' efforts towards safe and effective product development. This role will assist with the execution of global evidence management, publication planning, and scientific communication procedures, ensuring continual alignment with commercial and compliance objectives of the company.

ESSENTIAL FUNCTIONS

Identify, engage and liaise with medical and scientific experts, cultivating relationships and further developing an understanding of trends within the medical and scientific landscape.

Work with marketing, research, and development to identify scientific evidence needed to support new and mature products.

Work with organizational leaders and executive staff to develop global clinical development and scientific communication plans.

Cooperate with marketing, quality assurance, research and development, regulatory and clinical affairs, and legal teams, providing effective scientific leadership. Coordinate, edit and review interdepartmental collaborations, evidence assessments, and subsequent external communications.

Perform periodical and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives. Further, provide evidence reports to the Safety and Efficacy Review Board (SERB) of Smith & Nephew, reporting directly to the Chief Medical Officer.

Maintain familiarity with the body of published medical and scientific literature relating to the company's products and therapeutic areas, and provide expert knowledge and support in response to inquiries from internal and external customers, including healthcare professionals.

Manage evidence database capturing key evidence reports, publications, and external communications. Support dissemination of key evidence summaries to stakeholders.

Maintain thorough understand of complex and rapidly changing regulatory requirements and apply clinical and scientific direction on relevant matters. Complete comprehensive clinical evaluation reports in support of key regulatory submissions.

Identify clinical studies that are in alignment with key organizational objectives and evidence needs.

Additonal Activities: Develop evidence reports to support strategic commercial objectives. Manage periodical assessment of the competitive landscape and conduct strategic gap analyses of the literature. Support the development of scientifically accurate marketing and sales force materials. Ensure that all external scientific communication points and conclusions are accurate, supported by appropriate evidence, and aligned within the organization. Manage internal and external communications vendors to facilitate content planning and execution. Support key Scientific and Medical Affairs objectives and serve as a key internal contact and subject matter expert.

Desired profile

Bachelor's degree in Life Sciences, Nursing, Medical Technology or related discipline Master's or Ph.D. preferred.

Certified Medical Publication Professional (CMPP) certification , Regulatory Affairs Certification (RAC), or Certified Clinical Research Professional (CCRP) preferred.

At least three to five years of academic or industry experience developing evidence management, scientific communication and publication plans. Demonstrated ability to operate in a cross-functional global team environment and to interact internally and externally in a complex business environment.

1. Candidates must possess knowledge of regulatory guidance governing the completion of clinical evaluation reports.

2. Expertise in Microsoft Word, Excel, PowerPoint, and reference management software are absolutely essential. An understanding of statistical analysis is preferred.

3. Ability to critically assess and interpret complex scientific information, including excellent data interpretation.

4. Must possess excellent writing and oral presentation abilities.

5. Must be able to collaborate and work closely with marketing, quality assurance, research and product development, regulatory and clinical affairs, and legal teams.

6. Assist with assessing complex interdisciplinary issues and challenges.

7. Must demonstrate the ability to think strategically and work independently with a global team.

8. Must exhibit high quality, ethical and compliant work habits.

9. Must be capable of managing multiple projects simultaneously and under demanding timelines.

10. Must demonstrate effective decision making in matters that directly affect the commercial success and viability of the global organization.