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Senior Specialist - Clinical Trials Compliance & Standards - Now Hiring

Company: Horizon Therapeutics
Location: Buffalo Grove
Posted on: November 20, 2022

Job Description:

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

Position Summary:
The Senior Specialist, R&D Compliance and Standards works to ensure that Horizon's R&D complies with all internal and external standards (laws, regulations, directives, guidance, etc.) that are applicable to their activities. The Senior Specialist, R&D Compliance and Standards works closely with R&D functions to anticipate and prevent issues that may impact R&D compliance. This role may support any or all the responsibilities and tasks listed below.

It is the expectation that the Senior Specialist, R&D Compliance and Standards will be able to perform the following tasks independently, unless otherwise stated with support, oversight and/or direction:

  • Assist with generation/revision of policies, SOPs, forms, and guidelines as assigned
  • Manage controlled documents within Horizon's Quality Management System (QMS)
  • Update and/or maintain training for R&D personnel
  • With direction, create tools and training material to support R&D functions
  • Support partner audit/regulatory inspection readiness and audits/inspections
  • With direction, perform checklist driven review of R&D documents
  • Support site, vendor and/or internal audits and assessments
  • Assist with vendor KPI (Key Performance Indicators) tracking and other R&D Compliance metrics
  • Support change control, validation, and testing of R&D systems
  • Manage RDCS email mailbox
  • As assigned, mentor and support R&D Compliance and Standards team members
  • Other R&D Compliance support tasks as assigned
  • Ability to travel up to 10-15% over the course of a year

    Qualifications and Skills Required:
    • Bachelor's Degree, preferably in healthcare or clinical research
    • At least 3+ years of experience in clinical research
    • Previous experience in a compliance/quality role preferred
    • Strong technical writing skills
    • Ability to work under pressure and maintain flexibility
    • Attention to detail
    • Knowledge of 21 CFR 11, SO, 54, 56, 58, 312, and 812 as well as ICH E6R2
    • Proficient in Microsoft Office
    • Professional, proactive demeanor
    • Strong interpersonal skills
    • Excellent written and verbal communication skills
    • #LI-REMOTE
      Horizon Core Values & Competencies:

      • Manages Ambiguity
      • Strategic Mindset
      • Demonstrates Self-awareness
      • Cultivates Innovation
      • Develops Talent

        • Drives Results
        • Ensures Accountability
        • Decision Quality

          • Courage
          • Collaboration
          • Instills Trust


            Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department. Associated topics: clinical, clinical development, clinical informatics, clinical trial, coordinator, lab, laboratory, research, research coordinator

Keywords: Horizon Therapeutics, Buffalo Grove , Senior Specialist - Clinical Trials Compliance & Standards - Now Hiring, Healthcare , Buffalo Grove, Illinois

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