Public Disclosure and Transparency - Sr. Manager - Hiring Now

Company: Horizon Therapeutics
Location: Mount Prospect
Posted on: June 14, 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 primary responsibility is to oversee the completion of activities for all Horizon-sponsored clinical trials to comply with Global regulatory requirements for posting clinical trials on public websites (e.g., ClinicalTrials.gov, EudraCT, etc.) and reporting transfers of value to prescribers and other healthcare providers.

Responsibilities:

• Coordinate all activities related to clinical trial data sharing, publication of lay summaries, and redaction of trial documents according to Global regulations by performing these activities internally and/or managing selected vendors.
• Liaise with clinical study teams, attorneys, corporate communications, etc. to ensure timely and accurate information is agreed upon and released to the public.
• Remain up to date on Global Regulations and plan, coordinate, and prepare for internal presentations to ensure knowledge transfer to clinical study team members.
• Complete or manage Global reporting of transfers of value to prescribers and health care providers.
• Liaise with multiple vendors to ensure consistent reporting across all clinical studies and ensure proper filing of related finalized documentation.
• Manage vendors as needed to support activities of the department.
• Act as the subject matter expert during regulatory inspections.
• Review and update existing SOPs, guidelines, or work instructions and identify opportunities for process improvement.
• Participate in training and educational opportunities for personal development and cross-training within the organization.
• Manage and mentor direct reports to ensure consistency across departments.
  Qualifications and Skills Required:
  
  • BA or BS (or equivalent ex-US) degree
  • 7+ years experience managing Global Public Disclosure and Transparency activities
  • 2+ years' overseeing direct reports
  • Strong knowledge of the life science industry
  • Has familiarity with US FDA, ICH/GCP, and European Regulatory Authority requirements as applicable to a study (or the countries where a study is conducted).
  • Strong analytical and problem-solving skills
  • Ability to learn quickly and adapt to system and technology changes
  • Proficient in Microsoft Office, Adobe Acrobat, SharePoint, and clinical systems
  • Professional, proactive demeanor
  • Strong interpersonal skills
  • Excellent written and verbal communication skills
    Horizon Core Values & Competencies:
    
    Growth
    
    • Manages Ambiguity
    • Strategic Mindset
    • Demonstrates Self-awareness
    • Cultivates Innovation
    • Develops Talent
      
      Accountability
      
      • Drives Results
      • Ensures Accountability
      • Decision Quality
        
        Transparency
        
        • Courage
        • Collaboration
        • Instills Trust
          
          Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law.
          
          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.Required
          Preferred

          Job Industries

          • Customer Service

Keywords: Horizon Therapeutics, Mount Prospect , Public Disclosure and Transparency - Sr. Manager - Hiring Now, Executive , Mount Prospect, Illinois