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Job Details
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Job Information:
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Job title
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Medical Director - Electrophysiology or Cardiology
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Company
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Boston Scientific
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Wage
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between $0.00 - $0.00 Annually
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Location
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United States, Minnesota, Osseo
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Employment type
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Full Time
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Education
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Doctoral
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Year Experience
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3 - 4 Years of Practical Experience
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Travel
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None
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Published on
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1/10/2012
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Description
THIS POSITION MAY BE LOCATED IN MASSACHUSETTS OR MINNESOTA
Summary:
The Medical Directors at Boston Scientific drive the advancement of medical therapies across all areas of the business by rigorously and creatively applying their scientific and medical expertise to drive innovation and to ensure patient safety.
Senior Medical Directors possess and leverage their credibility to inform and influence internal and external customers, lead strategic research activities on high-profile studies, provide insights for and influence new products/indications supporting Cardiology, Rhythm and Vascular (CRV).
Responsibilities:
Provides high-level commentary on salient Medical Device Reports (MDRs). Responds to potential crises involving MDRs. Communicates with Senior Clinical Management. Communicates with outside entities as needed to support MDR surveillance.
Provides high-level commentary on salient complaints. Responds to crises involving complaints. Communicates to senior clinical management. Communicates with outside entities as needed.
Proactively identifies need for analysis of potential safety issue. Communicates results of analysis to senior clinical management as needed.
Crafts strategy and directs others for pre-approval regulatory activities. Meets and communicates with regulatory agencies.
Collaborates and interfaces with business units and development teams (clinical trials and preclinical) on projects of highly critical nature to support scientifically-sound decision-making related to new product or new indication development.
Serves as a key physician advisor in management review meetings.
Provides overall strategic medical input and approval for complex studies. Provides overall strategic advice on trial planning, execution/analysis and publication strategy for complex studies. Drives resolution for difficult or unclear cases.
Advises for recurring reports and reviews for all final reports and FDA submissions.
Serves as physician liaison to clinical trial team when high level decisions are needed (including high-level review meetings). Contributes to program overall development and strategy.
Advises in business critical, high risk or high visibility Product Inquiry Report (PIR) issues, provides authoritative opinion; anticipates challenges and poses unasked questions; may request additional investigation; provides critical review at all phases of PIR.
May provide guidance in resolution of medical issues with high visibility, high risk or strategic importance to business. Participates in management review of original documents and document updates that are high visibility, high risk, or of strategic importance.
Serves as physician representative on unusually sensitive or complex studies.
Provides specific medical education across division and corporation around specific issues. May provide focused educational sessions, including for senior management, to address high profile, high risk or business critical issues.
May supervise junior safety and/or medical personnel.
Establish environment and sets example for direct and effective communication.
Listen to employee career goals and aspirations; provide meaningful and thoughtful feedback on developmental challenges.
Quality Systems Duties and Responsibilities:
Champions Quality and Ethics policy within Department and across the clinical organization. Interprets these policies in difficult situations.
Recognizes opportunities for continuous improvement of medically related processes with strategic impact across multiple business systems and studies, e.g. using the Master Effects Severity List (MESL), a listing of the severity of all harms that may occur as a result of use of our devices, to drive classification of complaints & Adverse Events (AEs) to drive risk analysis occurrence numbers. Advises on the design and implementation of new processes.
Qualifications:
Medical degree required. Residency training, board certification or additional advanced degree in Cardiology or Electrophysiology preferred.
Minimum 3 years clinical experience with direct patient care (clinical years of medical school count towards direct patient care).
A minimum of 10 years of clinical trial or industry experience is required.
5 years coaching and mentoring. Direct managerial experience desired.
Working conditions:
General office envdf-hm
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Experience/Skills
Medical degree required. Residency training, board certification or additional advanced degree in Cardiology or Electrophysiology preferred.
Minimum 3 years clinical experience with direct patient care (clinical years of medical school count towards direct patient care).
A minimum of 10 years of clinical trial or industry experience is required.
5 years coaching and mentoring. Direct managerial experience desired.
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This job has expired.
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