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Clinical Evaluation Scientist II, Endoscopy Job

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Date: Jun 7, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MN-Minneapolis

 

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:

Responsible for the analysis and communication of clinical product risk across the project and product lifecycle.  Provides guidance in safety signal detection and assessment to communicate safety risks to project teams and senior management.  Ensures compliance with regulatory standards and guidelines, and corporate standard operating procedures as they relate to safety risk management.

 

Your responsibilities will include:

  • Identify appropriate scope and comparative information for Clinical Evaluation Reports and drive generation or updates for those documents.  Collaborate with cross-functional partners to obtain additional input to aid in clinical risk analysis
  • Conduct literature searches on products/product families to interpret and summarize harms, hazards, alternate therapies and device specific benefits from literature to support risk assessment.
  • Identifies the need for and/or generates risk management related documents on BSC products (commercial or under development) to support internal BSC and external regulatory agency requirements
  • Serves as a liaison between Risk Management function and project team.  Clearly communicates pertinent project/function information.
  • Collaborate with Clinical and R&D to develop common Clinical deliverable criteria and strategize justification for no clinical trial or aid in development of clinical trial rationalization plan.
  • Mentors and serves as subject matter expert in key risk management activities; participates as a risk management consultant for complex projects and for grouping similar products into logical and sustainable structure.
  • Dependent on level, 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.
     

What we're looking for in you:

Minimum Qualifications

  • Bachelor’s degree in Life Sciences
  • 3+ years experience in Clinical or Research environment
  • Medical and/or technical writing experience required

Preferred Qualifications

  • Medical Device industry experience preferred
  • Therapeutic area knowledge desired
  • Ability to work cross functionally at all levels of organization
  • Proven ability to analyze, interpret and synthesize clinical and commercial data

 

Requisition ID: 483110

 

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.


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