Clinical Evaluation Scientist II - IC Job
Additional Locations:
US-MN-Maple Grove; Ireland-Galway; US-CA-Valencia; US-MA-Marlborough
Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level.
With determination, imagination and a deep caring for human life, we re solving some of the most important healthcare industry challenges.
Together, we re one global team committed to making a difference in people s lives around the world.
This is a place where you can find a career with meaningful purpose improving lives through your life s work.
About the role:
This is a highly dynamic role in which you will work in a team environment to develop clinical documentation that systematically synthesizes information from multiple data sources.
As a Clinical Evaluation Scientist, you will plan and develop clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports, as well as summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs.
This role applies analytical thought processes and a highly methodical clinical evaluation approach to develop benefit/risk profiles for the Boston Scientific portfolio interventional cardiology devices.
A successful candidate has excellent writing skills as well as the ability to work collaboratively with cross-functional partners.
Your efforts support product approval, indication expansion and claim support, and mandated post-market requirements.
Your responsibilities include:
- Compile, appraise, and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data.
Includes development of literature search strategies and methodical evaluation of medical literature. - Create analyses to evaluate product benefit/risk profile and safety and performance and develop profile of adverse events.
Identify potential clinical evidence gaps and contribute to development of prospective evidence strategies to address gaps. - Ensure alignment of clinical data with risk documentation, and to contribute to product labeling.
- Aid in the development of regulatory responses for regulatory submissions
What we re looking for:
Basic Qualifications
- Bachelor s/Master s degree and 3
years professional experience or Advanced degree (PhD, research-based MS, MD, RN/DVM) - Analytical skills, including strong familiarity with scientific literature
- Strong medical/scientific writing skills
Preferred Qualification
- Knowledge of interventional cardiology/structural heart products and related disease states/ medical terminology
- Medical device experience, including understanding of regulatory
- Ability to understand engineering documentation, including risk documentation
About us
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE:
BSX) is to transform lives through innovative medical solutions that improve the health of patients.
If you re looking to truly make a difference to people both around the world and around the corner, there s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID:
474626
.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
