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Clinical Evaluation Specialist for Intervential Cardiology Devices
1 month ago
Overview
Boston Scientific is a leading medical device company that has been advancing science for life for over 40 years. Our mission is to improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
Job Summary
We are seeking a highly organized and analytical Clinical Evaluation Specialist to join our team. This role will be responsible for ensuring our products are safe for patients and work as intended by systematically analyzing data from multiple sources. The successful candidate will have excellent writing skills, be able to work collaboratively with cross-functional partners, and possess a strong familiarity with scientific literature.
About the Role
This dynamic role involves working in a team environment to apply analytical thought processes and a highly methodical clinical evaluation approach to support benefit/risk profiles for Boston Scientific's interventional cardiology devices. Key responsibilities include:
- Supporting the development of clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports in alignment with applicable clinical and regulatory standards and business needs.
- Compiling, appraising, and evaluating data from multiple sources, including clinical trials, medical literature, design verification/validation data, and product complaint data.
- Developing literature search strategies and methodically evaluating medical literature to support analyses and evaluate product benefit/risk profiles.
- Ensuring alignment of clinical data with risk documentation and contributing to product labeling.
Requirements
To be successful in this role, you will need:
- A minimum of a bachelor's degree.
- A minimum of 4 years of scientific writing experience, specifically in writing CERs.
- Strong analytical skills and familiarity with scientific literature.
- Excellent medical/scientific writing skills.
Preferred Qualifications
Advanced degree (PhD, research-based MS, MD, RN/DVM) Knowledge of interventional cardiology and related disease states/medical terminology Medical device industry experience Experience writing clinical evaluation reports
Earn an estimated $120,000 - $160,000 per year
Why Choose Boston Scientific?
We recognize that nurturing a diverse and inclusive workplace helps us be more innovative. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
