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Sr. Product Risk Specialist : Endoscopy
Location:
Marlborough, MA
Description:
Additional Location(s):US:MA:Marlborough; US:MN:Arden Hills; US:MN:Maple Grove 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 Sr. Product Risk Specialist is 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 and 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. Required qualifications: :Minimum of a bachelor's degree in Life Sciences:Minimum of 5 years experience in Clinical or Research environment:Medical and/or technical writing experience Preferred qualifications: :Medical Device industry experience preferred:Therapeutic area knowledge desired:Prior experience ofanalysis and communication of clinical product risk as it relates to products:Prior experience preferred of the clinical evaluation strategy for including development of CER, PMCF, and SSCP reports Requisition ID:582924 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 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 and look forward to connecting with you At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more i
Industry:
Insurance
Posted:
May 11 on Tip Top Job
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More About this Listing: Sr. Product Risk Specialist : Endoscopy
Sr. Product Risk Specialist : Endoscopy is a Human Resource Sr Product Risk Specialist Job located in Marlborough MA. Find other listings like Sr. Product Risk Specialist : Endoscopy by searching Oodle for Human Resource Sr Product Risk Specialist Jobs.
Sr. Product Risk Specialist : Endoscopy is a Human Resource Sr Product Risk Specialist Job located in Marlborough MA. Find other listings like Sr. Product Risk Specialist : Endoscopy by searching Oodle for Human Resource Sr Product Risk Specialist Jobs.