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Clinical Evaluation Scientist Specialist Job

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Date: Jul 16, 2021

Location: Diegem, BRU, BE

Company: Boston Scientific

Purpose Statement

 

 

This is a highly dynamic role in which you will work in a team environment to help develop global evidence-based clinical strategies for cardiology medical devices (CRM and Electrophysiology) by creating 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 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.

 

KEY RESPONSIBILITIES

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 strategy to address gaps.

•   Collaborate with leadership and cross-functional partners to develop global clinical strategies for new product development and/or EU MDR certification, ensure alignment of clinical data with risk documentation, and to contribute to product labeling.

•   Aid in the development and execution of strategies for regulatory responses for regulatory submissions.

  • Conduct literature reviews on products/product families to interpret and summarize harms, hazards, alternate therapies and device specific benefits from literature; collect and summarize primary data from the Design History File to support risk assessment.
  • Serves as a liaison between Risk Management function and project team. Clearly communicates pertinent project/function information.
  • Collaborate with Medical Sciences by providing harms, hazard and benefits information for the development/updates of the IFU.
  • Mentors and serves as subject matter expert in key risk management activities; participates as a risk management consultant for complex projects.
  • Dependent on experience, may serve as SME and Function representative in internal and external audits including audit participation, back room SME, preparing audit responses and supporting process improvements resulting from the audit

Quality System Requirements

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Management Requirements

 

  • Not applicable.

Job Scope, Qualifications and Leveling Guidelines

 

Qualifications

Minimum Qualifications

•  Bachelor’s/Master’s degree and 3+ years professional experience or Advanced degree

(PhD, research-based MS, MD, RN/DVM) and 3+ years professional experience

•  Analytical skills, including strong familiarity with medical literature

•  Strong medical/scientific writing skills

Preferred Qualification

•  Knowledge of cardiac rhythm management and electrophysiology medical device products and related disease states/ medical terminology

•  Medical device experience, including understanding of regulatory environment

•  Ability to understand engineering documentation, including risk documentation

 

Knowledge

A developing professional. Working knowledge and application of business and technical concepts, procedures and practices. General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function. Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.

 

Problem Solving

Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors. Exercises judgment to determine appropriate action. Has knowledge of alternatives and an understanding of their impact on the business or technological environment.

 

Planning and Organization/Project Management

Plans, organizes, and prioritizes own daily work routine to meet established schedule.

 

Discretion/Latitude; Supervision Received; Decision Making

Works under general direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpretating established policies, procedures and practices.  Work is reviewed for soundness of judgment.

 

Business Relationships and Project Management

Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks. May lead a project team of small to moderate scope. Influence exerted at peer level and occasionally at first levels of management.

 

Impact

Contributes to the completion of departmental projects and goals. Errors in judgment, poor recommendations, or failure to achieve results would normally require a moderate expenditure of resources to rectify.

 

Liaison

Engages with internal company and external contacts. Represents organization on specific projects.  Uses diplomacy and tact in interactions and problem solving.

 

Mentoring

Provides guidance to less experienced staff.

 

 

The above statements are intended to describe the general nature and level of work being performed
by people assigned to this classification. They are not intended to be construed as an exhaustive list
of all responsibilities, duties and skills required of personnel so classified. Job-specific training requirements associated with responsibilities and tasks personnel perform are established and demonstrated through their individual learning plan.

 

GE 2021


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