Director of Medical Affairs - Pittsburgh, United States - ZOLL Medical

    ZOLL Medical
    ZOLL Medical Pittsburgh, United States

    1 week ago

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    Description
    CMS

    At ZOLL, we're passionate about improving patient outcomes and helping save lives.

    We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

    The Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies.

    Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. To date, the LifeVest WCD has been worn by hundreds of thousands of patients and saved thousands of lives.

    ZOLL has been Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and even one of Pittsburgh's Coolest Offices. But it's our unique opportunity to impact people's lives that makes ZOLL the ideal place to build your career.

    Job Summary

    The individual in this position is accountable for fulfilling global medical affairs strategies and tactics. This individual will liaison with Engineering Research and Development for pre-clinical and clinical device testing.

    Essential Functions
    • Develop and execute the Global Medical Affairs strategy. This role will serve as the subject matter expert on all ZOLL CMS devices and services for both internal and external stake holders. Such functions will include collaborating with Regulatory and Quality Affairs, Legal, R&D, Sales, and Compliance on procedure review and execution.
    • Manage and oversee the quality of in house and contracted research data, and outside developers.
    • Manage and oversee the quality of data abstractors and clinical trial data management.
    • Ensure accuracy and timeliness of device event analyses and reporting required for Regulatory Affairs, Technical Support, Sales, and Corporate Counsel. This includes all aspects of supporting legal actions including appeals and case preparation.
    • Assist Regulatory Affairs with mandated clinical reporting and ad-hoc device performance characteristics, including company Metrics.
    • Support all facets of Clinical Operations as required.
    • Assist Engineering Research and Development in pre-clinical and clinical device testing, provide input into device design/use cases, and monitor / give feedback on commercial device performance.
    • Assist Reimbursement in qualifying patients for commercial device use and appealing denials according to CMS coverage guidelines.
    • Collaborate on science activities from study conception through study publication working directly with the Director of Scientific Affairs.
    • Provide tertiary support for Sales in answering prescriber questions.
    • Conduct individual performance reviews and manage to achieve departmental objectives.
    • Be responsible for departmental facets of HIPAA, GLP, GCP, clinical data integrity and security, and code of ethics.
    • Oversee and manage questions and issues raised by outside healthcare providers.
    • Participate in legal matters related to patients or device related concerns.
    • Responsible for monthly performance metrics reporting
    • Undertake any additional project assigned by the Vice President of Medical and Clinical Affairs
    Required/Preferred Education and Experience
    • PhD Medical Doctorate required
    • 4-6 years MD with 5 years of medical device industry or similar experience required
    • 4-6 years Experience in cardiology preferred
    • 4-6 years Experience in practicing clinical medicine. preferred
    Knowledge, Skills and Abilities
    • Sufficient understanding of FDA regulations and international regulatory requirements, clinical research methods, and biostatistics, as relevant to medical products.
    • Demonstrable ability to write and edit original scientific documents such as clinical summaries, investigator brochures, clinical protocols, and internal reports.
    • Comfortable working both internally and externally with technical and medical experts in providing input into future product development strategies.
    • Significant understanding of electrocardiogram interpretation, particularly rhythm analysis, is required.
    • Significant understanding of engineering developmental processes is highly desirable.
    • Prior experience with managing teams.
    Travel Requirements
    • 20% 15%-20% of Travel
    Physical Demands

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
    • Standing - Occasionally
    • Walking - Occasionally
    • Sitting - Constantly
    • Talking - Occasionally
    • Hearing - Occasionally
    • Repetitive Motions - Frequently
    ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.