Jobs
>
Pittsburgh

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

    ZOLL Medical Corporation
    ZOLL Medical Corporation Pittsburgh, PA, United States

    Found in: Lensa US 4 C2 - 4 days ago

    Default job background
    Description

    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.

    #J-18808-Ljbffr
  • VetJobs

    Medical Affairs Director

    Found in: Jooble US O C2 - 4 days ago

    VetJobs Pittsburgh, PA, United States

    It is open to Veterans, Transitioning Military, National Guard Members, Military Spouses, Wounded Warriors, and their Caregivers. When you are part of the team at Thermo Fisher Scientific, you'll do meaningful work, that makes a positive impact on a global scale You'll find the r ...

  • VetJobs

    Medical Affairs Director

    Found in: Lensa US 4 C2 - 4 days ago

    VetJobs Pittsburgh, PA, United States

    Job Description On behalf of VetJobs/MilitarySpouseJobs, thank you for your interest. We are assisting our partnering company, listed below, with this position. It is open to Veterans, Transitioning Military, National Guard Members, Military Spouses, Wounded Warriors, and their C ...

  • ZOLL Medical Corporation

    director of medical affairs

    Found in: Careerbuilder One Red US C2 - 4 days ago

    ZOLL Medical Corporation Pittsburgh, PA , USA, United States

    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 ...

  • Duquesne University

    director of clinical affairs

    Found in: Careerbuilder One Red US C2 - 5 days ago

    Duquesne University Pittsburgh, PA , USA, United States

    Director of Clinical Affairs - College of Osteopathic Medicine · Salary: Commensurate with experience · Benefits: Generous benefits include paid time off including holidays and vacation, retirement match, and tuition remission for employee and dependents. Details at · Location: ...

  • Attaineo Search, Inc.

    Director, Regulatory Affairs, AD/Promo

    Found in: Lensa US 4 C2 - 5 days ago

    Attaineo Search, Inc. Pittsburgh, United States

    Job Description · Position: Director of Regulatory Affairs, Advertising/Promotions (AD/Promo) · Location: Pittsburgh, Pennsylvania (Remote) · Overview: This role involves leading advertising and promotion activities, ensuring they comply with U.S. regulations. The ideal candid ...

  • Duquesne University

    Student Affairs Coordinator

    Found in: Lensa US 4 C2 - 3 days ago

    Duquesne University Pittsburgh, United States

    Student Affairs Coordinator - College of Osteopathic Medicine · Salary: Commensurate with experience · Benefits: Generousbenefits include paid time off including holidays and vacation, retirementmatch, and tuition remission for employee and dependents.Details at · Location: Col ...

  • University of Pittsburgh Medical Center

    medical director, medical oncology

    Found in: MyJobHelper US C2 - 4 days ago

    University of Pittsburgh Medical Center Pittsburgh, PA , USA, United States

    Purpose: · The Medical Director for Medical Oncology of UPMC Hillman Cancer Center, Zabok, will provide the leadership, vision, and clinical knowledge to build one of the pre-eminent cancer centers in Croatia. Supported by our UPMC Hillman physician leadership in Pittsburgh, the ...

  • University of Pittsburgh Medical Center

    medical director, radiation oncology

    Found in: MyJobHelper US C2 - 4 days ago

    University of Pittsburgh Medical Center Pittsburgh, PA , USA, United States

    Purpose: · The Medical Director for Radiation Oncology of UPMC Hillman Cancer Center, Zabok, will provide the leadership, vision, and clinical knowledge to build one of the pre-eminent cancer centers in Croatia. Supported by our UPMC Hillman physician leadership in Pittsburgh, th ...

  • Krystal Biotech, Inc.

    Director of HCP Marketing

    Found in: Lensa US P 2 C2 - 11 hours ago

    Krystal Biotech, Inc. Pittsburgh, United States

    Director of HCP Marketing · Who we are: · At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and commercialization of gene delivery medicines for patients with serious and life-threatening genetic dis ...

  • BioLife Plasma Services

    Medical Support Specialist RN

    Found in: Jooble US O L C2 - 3 days ago

    BioLife Plasma Services Pittsburgh, PA, United States

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...

  • Philips

    Head of Regulatory Affairs, S&RC

    Found in: Lensa US 4 C2 - 5 days ago

    Philips Pittsburgh, United States

    Head of Regulatory Affairs, S&RC · Lead and manage global teams of Regulatory Affairs professionals responsible for all Regulatory activities in support of the Sleep and Respiratory Care Business, which has critical global evidence-generation needs. · Your role: · - Responsibl ...

  • Spectraforce Technologies

    Pathologist

    Found in: Lensa US P 2 C2 - 11 hours ago

    Spectraforce Technologies Pittsburgh, United States

    Reference #: 9b1b85e7-69f0-4c4f-a5de-39442e9d2be1 Job title: Pathologist Location: Pittsburgh, PA 15201 Duration: 12 months Shift Hours: Monday through Friday 7:00 am - 3:30 pm Scope of Care: Contractor's physician(s) shall be responsible for providing PATHOLOGY Physician care, i ...

  • BioSpace

    MSL/Sr. MSL, Dermatology

    Found in: MyJobHelper US C2 - 2 days ago

    BioSpace Pittsburgh, United States

    Job Details · Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key the ...

  • VetsEZ

    Systems Administrator

    Found in: Lensa US P 2 C2 - 11 hours ago

    VetsEZ Pittsburgh, United States

    VetsEZ is seeking a full-time remote Systems Administrator to be responsible for overseeing the maintenance and security of intranets and computer systems. Including installing antivirus or malware protection software, responding to employee concerns, or drafting documents to hel ...

  • New Voices

    Development Manager

    Found in: Lensa US 4 C2 - 1 day ago

    New Voices Pittsburgh, United States

    About Us · New Voices for Reproductive Justice (New Voices) is a leader in the Reproductive Justice movement. With nearly two decades of experience in identity-based and issue-based leadership development, community engagement and organizing, and state and federal-level policy a ...

  • Wounded Warrior Project

    Veterans Benefits Services Manager

    Found in: Lensa US 4 C2 - 6 days ago

    Wounded Warrior Project Pittsburgh, United States Regular, Full time

    Great benefits. Competitive pay. We know these are some of the things people look for in a job. · But if you're the kind of person who also cares about making an impact and serving our nation's wounded warriors and their families, then you're exactly the kind of person we're look ...

  • Wounded Warrior Project

    Veterans Benefits Services Manager

    Found in: Lensa US 4 C2 - 3 days ago

    Wounded Warrior Project Pittsburgh, United States

    Great benefits. Competitive pay. We know these are some of the things people look for in a job. · But if you're the kind of person who also cares about making an impact and serving our nation's wounded warriors and their families, then you're exactly the kind of person we're look ...

  • Verona Pharma PLC

    respiratory sales specialist, pittsburgh, pa

    Found in: MyJobHelper US C2 - 4 days ago

    Verona Pharma PLC Pittsburgh, PA , USA, United States

    Respiratory Sales Specialist, Pittsburgh, PA (Pittsburgh, PA\/Washington\/Uniontown, PA), description: Respiratory Sales Specialist, Pittsburgh, PA (Pittsburgh, PA\/Washington\/Uniontown, PA) · The Company: · Our mission is to improve the health and quality of life for the millio ...

  • Commonwealth Of Pennsylvania

    Registered Nurse

    Found in: Lensa US P 2 C2 - 5 days ago

    Commonwealth Of Pennsylvania Pittsburgh, United States

    · THE POSITION · The Department of Military & Veterans Affairs is seeking hardworking and caring people who are dedicated to taking care of our residents. The Southwestern Veterans' Center offers veterans and their spouses superior care. · If you are an ambitious, confident Reg ...

  • Takeda Pharmaceutical Company Ltd

    Manager, Regulatory Affairs CMC

    Found in: Lensa US 4 C2 - 2 days ago

    Takeda Pharmaceutical Company Ltd Pittsburgh, United States

    By clicking the Apply button, I understand that my employment application process with Takeda will commence and that · the information I provide in my application will be processed in line with · Takedas · Privacy Notice · and · Terms of Use . · I further attest that all in ...