Boston Scientific Gruppe
Senior Clinical Evaluation Scientist
Boston Scientific Gruppe, Marlborough, Massachusetts, us, 01752
Additional Location(s):
US-MA-Marlborough; Costa Rica-Coyol; Costa Rica-Heredia; US-MA-Bedford; US-MA-Boston; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Northern/Duluth; US-MN-PlymouthAbout this role:This is a highly dynamic role in which you will work in a team environment to help create clinical documentation that systematically synthesizes information from multiple data sources. As a Clinical Evaluation Scientist, you will 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 interventional 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.This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills or Maple Grove, MN or Marlborough, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.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 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.Required qualifications:Minimum Bachelor’s/Master’s degree and 10 years professional experience OR an Advanced degree (PhD, research-based MS, MD, RN/DVM) and 5 years professional experienceProven experience writing clinical evaluation reportsPrior medical device industry experience or knowledge of interventional cardiology and related disease statesProven experience applying principles of EU MDRPreferred qualifications:Ability to understand engineering documentation, including risk documentationExperience with regulatory body communications
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US-MA-Marlborough; Costa Rica-Coyol; Costa Rica-Heredia; US-MA-Bedford; US-MA-Boston; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Northern/Duluth; US-MN-PlymouthAbout this role:This is a highly dynamic role in which you will work in a team environment to help create clinical documentation that systematically synthesizes information from multiple data sources. As a Clinical Evaluation Scientist, you will 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 interventional 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.This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills or Maple Grove, MN or Marlborough, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.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 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.Required qualifications:Minimum Bachelor’s/Master’s degree and 10 years professional experience OR an Advanced degree (PhD, research-based MS, MD, RN/DVM) and 5 years professional experienceProven experience writing clinical evaluation reportsPrior medical device industry experience or knowledge of interventional cardiology and related disease statesProven experience applying principles of EU MDRPreferred qualifications:Ability to understand engineering documentation, including risk documentationExperience with regulatory body communications
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