Lead – Evidence Evaluation & Communication (ENT), Global Clinical & Medical Affairs job opportunity at Smith+Nephew.

Home Jobs In United States Of America Tag: Global Clinical & Medical Affairs Lead – Evidence Evaluation & Communication (ENT), Global Clinical & Medical Affairs position at Smith+Nephew


DatePosted 17 Days Ago bot
Smith+Nephew Lead – Evidence Evaluation & Communication (ENT), Global Clinical & Medical Affairs
Experience: General
Pattern: full-time
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Global Clinical & Medical Affairs

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loacation US - Field, United States Of America
loacation US - Field....United States Of America

At Smith+Nephew , we design and manufacture technology that takes the limits off living. Within Global Clinical & Medical Affairs (GCMA), we play a critical role in generating, evaluating, and communicating the clinical evidence that demonstrates safety, performance, and value for patients and healthcare systems worldwide. This newly created global role offers a unique opportunity to take a leadership position at the heart of how evidence is evaluated and translated into real‑world impact for our innovative ENT portfolio. Reporting to the Senior Director, Evidence Analysis, Evaluation & Communication, you will lead clinical evaluations for regulatory purposes, drive critical appraisal and synthesis of evidence to support product claims, evidence gap analyses, and strategic decision‑making, and translate complex clinical and scientific data into clear, credible, and engaging communications. What will you be doing? Evidence Evaluation Lead the development and lifecycle management of Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), PMCF Evaluation Reports (PMCFERs), and Summary of Safety and Clinical Performance (SSCPs) in compliance with EU MDR and aligned to global standards. Drive systematic literature reviews, data extraction, and critical appraisal to support clinical evaluations and regulatory submissions. Serve as a subject matter expert during audits, notified body interactions, new product development and regulatory reviews, providing strategic input and responses to clinical questions. Maintain deep expertise in clinical practice, ENT technologies, treatment pathways, and regulatory frameworks including EU MDR 2017/745, MEDDEV 2.7/1 Rev 4, MDCG guidance and MDD 93/42/EEC. Evidence Analysis & Product Claims Critically appraise and synthesise clinical, scientific, and technical data to support product claims, evidence gap analyses, and commercial decision‑making. Contribute to the publication and presentation of evidence‑based work in peer‑reviewed journals and at scientific congresses, aligned with business priorities. Lead the claims management process for assigned products, ensuring alignment with clinical evidence, regulatory expectations, and commercial strategy. Review and approve promotional materials for scientific accuracy, regulatory compliance, and integrity. Scientific Narrative & Evidence Communications Lead the translation of complex clinical and scientific evidence into engaging narratives and assets, tailored to the needs of diverse internal and external audiences. Develop and own the evidence communication strategy for priority brands. Partner cross‑functionally, e.g., Global Marketing, Global Medical Education, Global Clinical Strategy, to ensure evidence assets are strategically aligned and scientifically robust. Establish and embed approaches to measure impact, using feedback and performance metrics to continuously improve the effectiveness of evidence communication materials. Cross‑functional leadership Partner closely with Global Clinical Strategy, Regulatory Affairs, Global Marketing, Global Market Access and Global Medical Education to ensure alignment and impact. Collaborate with external partners including notified bodies. medical writers, and creative agencies. What will you need to be successful? A degree in a relevant biomedical or clinical discipline (PhD advantageous). Significant relevant experience within the medical device or pharmaceutical sector. Demonstrated expertise in clinical evidence evaluation and regulatory documentation, including CERs, CEPs and PMCF Evaluation Reports, aligned with key regulatory frameworks such as EU MDR and MEDDEV 2.7/1 Rev 4. Proven ability to conduct systematic literature reviews, critically appraise clinical and scientific data, and synthesise evidence to support regulatory and commercial decision‑making. Strong capability to translate complex clinical and scientific data into clear, credible scientific narratives for varied internal and external audiences. Experience in reviewing promotional and educational assets, ensuring alignment with clinical evidence, regulatory requirements, and commercial strategy. A track record of publishing scientific or clinical evidence in peer‑reviewed journals and presenting at scientific congresses (preferred). Confidence working autonomously in a global, matrix environment, with the ability to influence and lead without formal authority. A mindset combining scientific rigour, strategic thinking, and communication excellence, grounded in strong commercial understanding. You Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.     Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/). Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement   Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day   Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program  Flexibility: Hybrid Work Model (For most professional roles)   Training: Hands-On, Team-Customized, Mentorship   Extra Perks: Discounts on fitness clubs, travel and more!   The anticipated base compensation range for this position is $123,263 - $160,000 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP. 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. Stay connected by joining our Talent Community . We're more than just a company - we're a community! Follow us on L inkedIn to see how we support and empower our employees and patients every day.    Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You . Unlimited . , life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer.    

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