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Principal Clinical Research Scientist

Company: Abbott Laboratories
Location: Saint Paul
Posted on: April 4, 2021

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION: Principal Clinical Research Scientist Leading an active lifestyle is important to the many people we serve. In Abbott's Electrophysiology & Heart Failure division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies, allowing people to restore their health and get on with their lives.-- As Principal Clinical Research Scientist, you will lead the development of clinical evidence generation plans that describe the strategy, anticipated scope and projected timelines to develop all the clinical evidence needed to support a product/product family through its full lifecycle. This plan will outline the steps to establish feasibility, achieve regulatory approvals and meet ongoing regulatory requirements, gain reimbursement and support full commercial adoption. You will analyze and interpret scientific data and write clinical study protocols, reports and scientific publications. In this role, you will interact with physician Key Opinion Leaders and various cross-functional teams, including Marketing, R&D, Risk Management, Reimbursement, Medical Affairs, Quality and Regulatory Affairs. You will also interact with global regulatory agencies to obtain market approval of new products and study sites to train on study protocols, obtain Ethics Committee / IRB approval and respond to questions throughout the study. Primary Duties and Responsibilities

  • Comply with applicable Corporate and Divisional Policies and procedures.
  • Lead the development of clinical strategy and study design.
  • Provide technical leadership to business units and physicians.
  • Write study protocols, study reports, and scientific papers for publication by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice.
  • Interpret results and write reports for regulatory applications
  • Facilitate communication between Sales and Marketing, R&D, Program Management, Reimbursement, Medical Affairs, Risk Management, Quality and Regulatory Affairs, and investigational sites.
  • Present regular updates to senior staff.
  • Oversee study Steering Committees and Publication Committees, consisting of physician Key Opinion Leaders globally.
  • Present clinical study results at medical device congresses, investigator meetings and meetings with regulatory agencies
  • Participate in and support audits.
  • Participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring.
  • Act as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.
    Required Qualifications :
    --
    • Bachelor's degree in engineering, medicine, healthcare or sciences--
    • 8+ years of related research work experience
    • Demonstrated understanding of business environment and relates extensive knowledge of internal and external technological activities to trends.
    • Experience interfacing with senior management on significant matters, often requiring the coordination of activity across organizational units.
    • Ability to participate in the development of other technical contributors by facilitating training and providing feedback and guidance.
    • Ability to plan and organize project assignments of substantial variety and complexity.
    • Requires ability to be innovative, resourceful, and work with minimal direction
    • Requires excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
    • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
    • Strong organizational and follow-up skills, as well as attention to detail. Preferred
      --
      • Advanced degree in the sciences, medicine, or similar discipline highly preferred
      • Experience in the medical device industry
      • Experience with international medical device regulations and submissions.
      • Familiarity with relevant international regulatory requirements for medical devices including Quality Systems standards and clinical investigations.WHAT WE OFFER----At Abbott, you can have a good job that can grow into a great career. We offer:--
        • Training and career development, with onboarding programs for new employees and tuition assistance
        • Financial security through competitive compensation, incentives and retirement plans
        • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs--
          • Paid time off
          • 401(k) retirement savings with a generous company match--
          • The stability of a company with a record of strong financial performance and history of being actively involved in local communities--Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.--Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.--JOB FAMILY:Research and DiscoveryDIVISION:EPHF Electrophysiology & Heart FailureLOCATION:United States > Minnesota > Plymouth : 5050 Nathan Lane NADDITIONAL LOCATIONS:United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza, United States > Minnesota > St. Paul > Tech Center : One St Jude Medical DriveWORK SHIFT:StandardTRAVEL:Yes, 20 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Posted 2 Days Ago Full time 30967084 About Us Abbott-- is about the power of health. For more than 125 years,-- Abbott-- has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of-- Abbott-- come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges. We invite you to explore opportunities at-- Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer,-- Abbott-- welcomes and encourages diversity in our workforce.

Keywords: Abbott Laboratories, St. Paul , Principal Clinical Research Scientist, Healthcare , Saint Paul, Minnesota

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