Director, Global Labeling

05 Sep, 2022

Jobs

Director, Global Labeling

Horizon Therapeutics
Deerfield, IL

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:

As a Director of Labeling, you’ll play an important role in managing processes and key stakeholder relationships to support global product labeling development throughout the product lifecycle to ensure compliance with global regulatory standards. You will lead a team of labeling professionals responsible for driving labeling strategy and label development as well as managing cross-functional labeling activities to meet Company goals for submission, approval and maintenance of global compliant labeling as outlined below. This position may also serve as Global Labeling Lead for assigned products.

 

Responsibilities:

  • Establish the internal processes for the development and maintenance of key product labels (US PI, EU SmPC)
  • Serve as internal expert for labeling development and the lead for the Horizon Global Labeling Governance Committee (GLGC), providing oversight to Labeling Working Teams (LWTs) in the creation of product labels
  • Contribute to cross-functional initiatives and identify opportunities to influence regulatory policy and climate with respect to labeling content
  • Ensures CCDS/labeling documents are prepared and executed in accordance with applicable regulations and company position.
  • Ensure that key stakeholders and line management are informed of key labeling issues/risks with mitigation plans.
  • Proactively manage workload and monitors progress against submission timelines, prioritizes resources to meet Company objectives
  • Understands and interprets complex issues as related to regulatory requirements and labeling strategy. Partners with key internal and external stakeholders to resolve issues.
  • Provide leadership and development for direct reports

 

Qualifications and Skills Required:

  • Minimum of 10-15 years of experience in Regulatory Affairs with strong knowledge of product labeling development
  • Expert knowledge of global labeling guidance documents and regulations
  • Proven understanding of the dynamics and purpose of the Company Core Data Sheets (CCDS) and the implications of the CCDS
  • Proven ability to understand regulatory implications of product strategy related to labeling development, assessment and management
  • Demonstrated ability to develop strong and positive working relationships across diverse teams and within a global environment
  • Experience in people management and developing and managing a highly competent and technically skilled team including remote team members
  • 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.

Learn more here

Job posted: 2022-09-05