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Job Details

Clinical Product Risk Specialist JobClinical Product Risk Specialist Job

Company name
Boston Scientific Corporation

Arden Hills, MN

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Additional Locations: (n\/a) Purpose and Passion \u2022 Comprehensive Benefits \u2022 Life-Work Integration \u2022 Community \u2022 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\u2019re solving some of the most important healthcare industry challenges. Together, we\u2019re one global team committed to making a difference in people\u2019s lives around the world. This is a place where you can find a career with meaningful purpose\u2014improving lives through your life\u2019s work. About the 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 experience, understanding of scientific research methodologies, technical knowledge of products, processes, and regulatory requirements to conduct clinical risk assessment within a given therapeutic area. *Level of role will be dependent upon candidate's education and experience. Your responsibilities will include: \u00a0 Writes Clinical Experience 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. May collaborate on risk assessment and writing of product labeling. Efforts and leadership supports product approval, indication expansion and claim support, and mandated post market requirements. Leads the development of clinical risk strategy by conducting meetings with the appropriate departments and individuals to obtain feedback\/direction. Provides project leadership and scientific expertise throughout product development and implementation of local or global Regulatory requirements. Provides clinical input for new product development, post market surveillance, recertification and business development. Interacts with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables. Interacts with regulatory agencies as needed, and will use their scientific knowledge in order to provide directives to staff as well as study sites. Facilitates clinical risk communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management, by conducting cross-functional team meetings, and by presenting regular updates to senior staff (BPT\/PIB, etc). Manages clinical risk timelines required by global Regulatory Bodies by utilizing the appropriate project management tools. Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings. Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Medical Ethics Committees, etc. May include clinical risk management activities including input into Hazard Analyses, product FMEA and DFUs and authorship of Clinical Evaluation documents (CES, CRBA, CDSR) for identification of harms and support of safety performance for product approval. What we're looking for in you: Minimum Qualifications Bachelor\u2019s degree and 5 years of related work experience or an equivalent combination of education and work experience. Electrophysiology (EP)\/Cardiac catheterization Clinical Risk\/Safety\/Trial experience preferred, technical experience desired Medical\/Technical writing experience Ability to review and synthesize medical publications and\/or competitive product literature Preferred Qualifications Ability to apply comprehensive technical knowledge of a particular field 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.

Company info

Boston Scientific Corporation
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Company Profile
Our products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’s health, and chronic pain conditions. We continue to innovate in these areas and are extending our innovations into new geographies and high-growth adjacency markets.

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