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Specialist Regulatory Affairs - Molecular Diagnostics

Company: Abbott Laboratories
Location: Des Plaines
Posted on: August 5, 2022

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 113,000 colleagues serve people in more than 160 countries.Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.Abbott Molecular has an opening in its Des Plaines, IL site for a Specialist Regulatory Affairs.WHAT YOU'LL DO:

  • Prepares technical documents to support both domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications for diagnostic assays and instruments. Incorporates text, graphs, charts, tables, statistical analyses, etc. in a clear and accurate manner.
  • Confirms that data are presented in a clear, complete, accurate, and concise manner.
    • Serves as the Medical Writing representative on product teams.
    • Coordinates all activities related to the preparation and compilation of data and information into a single comprehensive package for new and revised domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications for diagnostic assays and instruments.
    • Communicates deliverables needed and writing process to team members.
    • Accesses resource needs as timelines progress, and communicates those needs to management.
    • Utilizes submission templates (if available) and format/style guidelines established by Medical Writing.
    • Obtains relevant product data and information.
    • Assesses accuracy of information.
    • Understands sources of information.
    • Converts relevant product data and information into a form that meets submission requirements.
    • Reviews, circulates, edits, assembles, inspects, and duplicates product submissions.
    • Uses AMD manufacturing/ testing documentation systems.
    • Determines format for submissions and documents.
    • Interprets data, and verifies that results are consistent with protocols.
    • Confirms completeness of information to be presented.
    • Confirms label and package insert claims are supported by and consistent with data presented in the submissions.
    • Acts as interface to resolve issues and questions arising during writing process.
    • Arranges and conducts review meetings with teams on submission and related labeling.
    • Coordinates responses to inquiries, questions, and deficiencies received from submission reviewers both in the US and internationally.
    • Interprets and explains data generated from a variety of sources, including internal experiments, research documentation, charts, graphs, and tables.
    • Explains the data in a manner consistent with the target audience and regulatory requirements.
    • May recommend and implement process improvements.
    • Responsible for implementing and maintaining the effectiveness of the Quality System.
    • Accountability/Scope/Budget
    • Drafts domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications for new diagnostic assays and instruments.
    • Coordinates activities with product development teams to ensure goals are met.
    • Expected to meet quality standards for accuracy and completeness.
    • Works independently with some supervision.Education/ Skills/ Experience:Required:
      • Bachelor's degree in Science, Medical Technology, English, or equivalent experience. American Medical Writers Association (AMWA) certification is desired, with a specialty in Editing/Writing or Pharmaceutical.
      • Minimum 2 years relevant professional experience, in a related area such as R&D, Technical Product Development, Quality, Regulatory Affairs, Clinical Research, or Medical Writing.
      • 2+ years experience in experimental design and data interpretation preferred.
      • Knowledge of AMD products desirable. Good written and oral communication skills. Superior attention to detail.
      • Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
      • Fluent in word processing, flow diagrams and spreadsheets.
      • Good working knowledge of personal computer software programs in Windows environment.
      • Good communication, interpersonal, and team skills. Ability to critically review own work before sending out for internal/external review by team.Preferred:
        • 2+ years writing experience as a medical writer in the health care industry preferred.WHAT WE OFFERAt Abbott, you can have a good job that can grow into a great career. We offer:
          • Training and career development, with on-boarding programs for new employees and tuition assistance
            • Financial securitythrough competitive compensation, incentives and retirement plans
            • Health care and well-being programsincluding medical, dental, vision, wellness and occupational health programs
            • Paid time off
            • 401(k)retirement savings with a generous company match
            • The stability of a companywith a record of strong financial performance and history ofbeing actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: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, on Facebook atand on Twitter @AbbottNews and @AbbottGlobal.

Keywords: Abbott Laboratories, Des Plaines , Specialist Regulatory Affairs - Molecular Diagnostics, Other , Des Plaines, Illinois

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