Clinical Evaluation Scientist II - IC Job

Company: Boston Scientific Gruppe
Location: Marlborough
Posted on: February 25, 2021

Job Description:

Clinical Evaluation Scientist II - IC Job Additional Locations: Ireland-Galway; US-CA-Valencia; US-MA-Marlborough; US-MN-Maple Grove 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 this 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 will 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 in you:-- Minimum--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
      Nearest Major Market: Boston
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Keywords: Boston Scientific Gruppe, Boston , Clinical Evaluation Scientist II - IC Job, Healthcare , Marlborough, Massachusetts