Share this Job

Senior Clinical Product Risk Specialist Job

Apply now »
Apply now

Apply for Job

Date: May 3, 2019

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

Additional Locations: (n/a)

 

 

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:

Responsible for participating in cross functional development teams as the clinical representative in support of the organization's business objectives for product development and/or commercialization as well as sustaining.  Possesses medical writing expertise, understanding of scientific research methodologies, technical knowledge of products, processes, and regulatory requirements to conduct clinical risk assessment within a given therapeutic area.

 

Your responsibilities will include: 

  • Writes Clinical Evaluation Reports by 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. Creates relevant clinical documentation in support of related clinical evaluation deliverables to comply with applicable clinical and regulatory standards. May collaborate on risk assessment and writing of product labeling. 
  • Interacts with various contributory functions to coordinate clinical content in documents supporting regulatory interactions related to clinical trial activities, post-approval requirements and questions from various regulatory bodies. Contributes to regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.  
  • Collaborates cross-functionally with Sales and Marketing, R&D, Regulatory Affairs, Quality, and Medical Director/Medical Safety to drive toward project deliverables. 
  • Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies.  May include clinical risk management activities including input into Hazard Analyses, product FMEA and DFUs for identification of harms and support of safety performance for product approval.

 

What we're looking for in you:

Minimum Qualifications

  • Bachelor’s degree with a scientific focus 
  • 3+ years of related work experience or an equivalent combination of education and work experience.
  • Medical/Technical writing experience
  • Ability to review and synthesize medical publications and/or competitive product literature

Preferred Qualifications

  • Electrophysiology (EP) and/or Cardiac Rhythm Management (CRM) Clinical Risk/Safety/Trial experience preferred, technical experience is desirable.
  • 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.
  • Strongly prefer a professional with a wide-range of experience and expertise in a specialized technical field.

 

 

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: 445796

 


Nearest Major Market: Minneapolis

Job Segment: Clinic, Risk Management, Medical, Law, Product Development, Finance, Healthcare, Legal, Research