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Clinical Scientist II, Neuromodulation - Remote Job

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Date: Apr 26, 2021

Location: Valencia, CA, US, 91355

Company: Boston Scientific

Additional Locations:

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

About the role:

Uses comprehensive skill set and understanding of clinical evaluation and risk for medical devices as they relate to multiple therapeutic areas. Collaborates with various internal functions to provide clinical support and expertise for projects. Represents function to internal cross-functional partners.

 

This role can sit remotely. 

 

Your responsibilities include:

  • Support product development and sustaining teams in the evaluation of product risk and design control process. Ensure clinical accuracy in risk documentation, e.g. hazard analysis (HAs), risk management plans/reports (RMP/RMR), and product labeling, i.e. Instructions for Use (IFU). Utilize understanding of therapeutic area and procedures to identify and interpret information impacting quality.
  • Author clinical evaluation documents, e.g. clinical evaluation plans and reports (CEP/CER), post market clinical follow-up (PMCF) plans, summary of safety and clinical performance (SSCP) for support of safety and performance for product approval and identification of harms.
  • Ensure linkage between clinical harms identified in clinical evaluations and risk analysis throughout the product lifecycle; create/maintain risks lists for clinical studies and IFUs.
  • Serve as Clinical representative on project teams; Build and maintain strong relationships with internal scientific, technical, and organizational leaders to support Regulatory, Clinical, and product strategies; clearly communicate pertinent project/function information.
  • Contribute to process improvements within function.
  • Serves as function support in Regulator responses, and in internal and external audits including audit participation, preparing audit responses and supporting process improvements resulting from the audit.
  • Assist Medical Director, Medical Safety, and Clinical study teams with product risk research and information as needed.

 

What we’re looking for:

Basic Qualifications

  • 4+ years of relevant industry experience
  • Bachelor’s Degree in relevant field
  • 2+ years’ experience writing clinical evaluation documents
  • Experience with CEP/CER, PMCF, and SSCP documents and plans

Preferred Qualifications

  • 5+ years of relevant industry experience
  • 4+ years' experience writing clinical evaluation documents
  • Master’s Degree in relevant field

 

 

Requisition ID: 479776

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why 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. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


Nearest Major Market: Los Angeles

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