- 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.
- 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
- Medical Device industry experience preferred
- Therapeutic area knowledge desired
- Prior experience of analysis 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
-
Product Risk Specialist III
1 week ago
Boston Scientific Marlborough, United StatesThe Product Risk Specialist III 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 te Risk, Specialist, Endoscopy, ...
-
Product Risk Specialist III
1 week ago
Boston Scientific Marlborough, United StatesAdditional Location(s): US-MN-Arden Hills; US-MN-Maple Grove; US-TX-Houston · 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 o ...
-
Field Risk Specialist
2 weeks ago
Datascan Technologies, LLC Watertown, United StatesOffering $10K Sign On Bonus Position: Field Risk Specialist - This is a Field Based Position so you will not be assigned to a local office, candidates must be located in the Watertown, SD area. · About DataScan · Headquartered in Alpharetta, Georgia, DataScan stands at the fore ...
-
Climate Risk Specialist
2 weeks ago
Arcadis Boston, United States Part timeArcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. · We are more than 36, people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the ...
-
Risk Adjustment Specialist
3 days ago
Atrius Health Watertown, United States Part timeSUMMARY · Under general direction, conducts medical record reviews to ensure that all documented chronic disease (HCC) diagnoses are captured allowing the opportunity for optimal health risk scores. Reviews clinical data from EpicCare and outside claims to ensure that all chroni ...
-
Field Risk Specialist
2 weeks ago
Datascan Technologies, LLC Watertown, United StatesJob Description · Job DescriptionOffering $10K Sign On Bonus Position: Field Risk Specialist - This is a Field Based Position so you will not be assigned to a local office, candidates must be located in the Watertown, SD area. · About DataScan · Headquartered in Alpharetta, Geo ...
-
Risk Adjustment Specialist
1 week ago
Atrius Health Newton, United StatesAtrius Health is a nonprofit healthcare leader delivering a system of connected care that enables us to know our patients better so that we can serve them well. Across 32 clinical locations, more than 50 specialties and 825 physicians, we provide proactive, customized care to mor ...
-
Credit Risk Specialist, Senior
3 weeks ago
Federal Reserve System Boston, United StatesThis job is eligible for a hybrid schedule with some on-site work expected. The individual is expected to reside in the 1st District unless you were given an exception.The · Senior Credit Risk Specialist · leads and/or participates in reviews and examinations that evaluate the ...
-
Risk Adjustment Specialist
1 week ago
Atrius Health Newton, United States**Risk Adjustment Specialist** · Atrius Health is a nonprofit healthcare leader delivering a system of connected care that enables us to know our patients better so that we can serve them well. Across 32 clinical locations, more than 50 specialties and 825 physicians, we provide ...
-
Cyber Risk Specialist
2 weeks ago
McKinsey & Company Boston, United States**Who You'll Work With**: · - You will be based in our Boston, Chicago, New York, Silicon Valley or Washington DC office as part of our global Risk & Resilience practice.- You will work with other members of our global Risk & Resilience practice as well as colleagues in McKinsey ...
-
Discover Riverwoods, United States**Discover. A brighter future.** · With us, you'll do meaningful work from Day 1. Our collaborative culture is built on three core behaviors: We Play to Win, We Get Better Every Day & We Succeed Together. And we mean it - we want you to grow and make a difference at one of the wo ...
-
Regulatory Risk Managment Specialist
1 month ago
Northern Trust Boston, United States Full timeAbout Northern Trust: · Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. · Northern Trust is proud to provide innovative financial services and guidance to the world's most suc ...
-
Senior Specialist, Risk Management
1 week ago
National Grid Waltham, United StatesAbout us · Every day we deliver safe and secure energy to homes, communities, and businesses. We are there when people need us the most. We connect people to the energy they need for the lives they live. The pace of change in society and our industry is accelerating and our exper ...
-
Social Compliance Manager
5 days ago
The TJX Companies, Inc. Marlborough, United StatesThe Opportunity: Contribute To The Growth Of Your Career · At TJX, our philosophy towards social compliance mirrors our culture, and just as we have committed to honesty, integrity, and treating others with dignity and respect, we expect those that we do business with to do the s ...
-
TJX Companies Marlborough, United States Full timeJOB DESCRIPTION Discovery is at the core of everything we do - whether it's a great value, incredible style, or building long-lasting partnerships with people around the world. That's what makes TJX different. You can find it all across our brands: TJ Maxx, Marshalls, HomeGoods, ...
-
Senior Global Continuous Improvement Specialist
3 weeks ago
The TJX Companies, Inc. Marlborough, United StatesSenior Global Continuous Improvement Specialist · What you'll do · Global Continuous Improvement delivers value across the TJX organization through the execution of initiatives strategically aligned with the TJX Business Priorities and leveraging Continuous Improvement, Program M ...
-
Sales Associate
3 weeks ago
Xerox Marlborough, United States Full timeOverview: · Conway Technology Group, LLC, A Xerox Company, is an information services technology company that has continually redefined the workplace experience for more than 100 years is currently seeking a Sales Executive to support the greater Worcester and Marlborough, MA ar ...
-
Senior Contract Specialist
3 weeks ago
Babcock Power Marlborough, United StatesBabcock Power is an Equal Opportunity Employer (M/F/D/V). · Start Over with Job Search · Returning Applicant? Login Now Senior Contract Specialist · Company:Babcock Power Services Location:Marlborough, MA Job Type:Legal Position Summary: Join a talented team of engineering profes ...
-
Senior Contract Specialist
1 week ago
Babcock Power Marlborough, United StatesPosition Summary: · Join a talented team of engineering professionals at Babcock Power. Babcock Power is the leading supplier of technology, equipment and engineering services, to the power generation industry. We are an industry leader with both domestic and international custo ...
-
Manager, Quality Systems
1 week ago
Quest Diagnostics Marlborough, United StatesOverview: · Manage the quality management system and regulatory requirements for Quest Diagnostics to comply with all applicable regulations and standards including but not limited to FDA CFR Part 820 (QSR), ISO Quality Systems), ISO Risk Management), IVDR 2017/746 (In-Vitro Dia ...
Sr. Product Risk Specialist - Marlborough, United States - Boston Scientific
Description
Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple GroveDiversity - 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:
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 prohibited substance free workplace. Pursuant to Va. Code § , 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.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.
