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Manager I, Clinical Evidence Evaluation Job

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Date: Nov 10, 2021

Location: Marlborough, MA, United States, 01752

Company: Boston Scientific

Additional Locations: US-MA-Marlborough; Costa Rica-Coyol; Costa Rica-Heredia; Ireland-Galway

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - 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:
The Manager I, Clinical Product Risk has a solid understanding of clinical evaluation and post-market clinical follow-up (PMCF) under EU MDR, and will use this skillset to lead/guide a small team in our imaging and diagnostics group. A person in this role will have a strong understanding of how to execute clinical evaluation strategies, and be able to apply these strategies across device classifications, as well as for single-use, capital equipment, and software. A Manager I splits time between coaching/mentorship, writing, and interfacing with product teams.

 

Your responsibilities will include:

  • Execute, lead and train others on all aspects of Clinical Evaluation Report (CER) research, analysis, interpretation and document generation.  Identify issues, develop and communicate proposed solutions to teams and senior management as required.
  • Independently utilize understanding of therapeutic area to identify and interpret information impacting clinical evidence and risk management by mentoring individual contributors in evaluating scientific literature and publications, reviewing hazard analyses and other risk documents, reviewing product complaint data, analyzing scientific data and staying abreast of current clinical practice.
  • Lead junior staff through process to author clinical evaluations and ensure team creates relevant clinical documentation in support of related clinical evaluation deliverables to comply with applicable clinical and regulatory standards.
  • Identifies functional area specific project risks.  Develops and executes contingency and mitigation plans for programs.  Work with contractors and/or vendors to complete work as necessary and ensure compliance to training, corporate standards and regulatory agencies.
  • Serves as Clinical Risk Management SME on project team; makes decisions and clearly communicates pertinent project/function information.  Determines clinical and cross-functional resources and expense requirements for team as applicable.  Collaborates with functional manager or director on quarterly budget issues.
  • Collaborate with Clinical and R&D to develop common Clinical deliverable criteria and strategize justification for clinical evidence plans related to CER and MEDDEV/MDR compliance or aid in development of clinical trial rationalization plan.  Negotiate resource utilization to ensure deliverables are met within timeline and budget. 

 

Required qualifications:

  • Bachelor’s degree with a scientific focus
  • 7+ years of related work experience or an equivalent combination of education and work experience.
  • CER experience under EU MDR
  • Medical/Technical writing experience

 
Preferred qualifications:

  • Experience working with capital equipment/diagnostics
  • Advanced degree (Ph.D. or other)
  • Medical experience highly desirable.
  • Excellent communication skills (written and verbal).
  • Ability to apply comprehensive technical knowledge to resolve complex issues in creative ways.
  • Ability to use in-depth knowledge of business unit functions and cross group dependencies/relationships.
     

 

Requisition ID: 510159

 

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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