Specialist/Senior Specialist , PRC

Company: Horizon Therapeutics
Location: Deerfield
Posted on: May 21, 2023

Job Description:

At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us. The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees' personal and professional lives. Position SummaryAs a Senior Specialist, Promotional Review Committee, you will play an important role in coordinating our medical, regulatory and legal review in support of our various brands. This is a highly interactive and cross-functional role where you will develop an understanding of the brand team's business and focus on effectively managing relationships with key stakeholders.Responsibilities

• Facilitate, maintain and lead the Promotional Review Process (medical, regulatory and legal review) of materials or information intended to be available to health care professionals, patients, consumers, or other customers, which refer to an approved or investigational product.
• Manage all day-to-day activities for assigned products of the Promotional Review Process which includes interaction with and training of both internal and external stakeholders (includes, but is not limited to, medical, regulatory, legal, marketing, etc.).
• Plan and lead PRC meetings, prepares and maintains documents necessary for effective dialogue, and documents assignments, follow-up items and meeting outcomes. Ensures involvement of appropriate functions/individuals in relevant meetings, decisions and working groups. Escalates matters to PRC Manager as needed.
• Support the Promotional Review Committee (PRC) document control process and systems; routing documents to internal and external reviewers and obtaining and collecting requisite approvals.
• Lead weekly status meetings with assigned brand teams and agencies.
• Ensure adherence to timelines for submission of material into the promotional review system.
• Troubleshoot bottlenecks in workflow system.
• Review assigned submissions for completeness and accuracy based on defined PRC standards.
• Act as the point of contact and communicate project and process status adequately to all participants. Modify level of communication to meet audiences' level of need-to-know basis.
• Coordinate schedule of OPDP (FDA's Office of Prescription Drug Promotion) submissions with Regulatory team.
• Effectively prioritize pieces during times of high volume - product launches, sales meetings, etc. - balancing competing objectives to ensure deliverables are on time and within budget.
  • Conducts and manages bi-monthly training sessions for new PRC users on process and system.
  • In conjunction with PRC Manager, perform internal audits of PRC process and internal procedures to measure compliance, and identify efficiencies driving to process optimization.
  • Complete special projects as assigned by PRC Manager to support process improvement and efficiencies. Qualifications and Skills Required
    • Bachelor's degree required
    • 2+ years experience in PRC Lead role
      • Proficient in Microsoft Office
      • Professional demeanor
      • Self-starter attitude
      • Strong interpersonal skills
      • Excellent written and verbal communication skills
      • Demonstrates knowledge and experience with process management
      • Experienced in Veeva Vault PromoMats or related software
      • Knowledge of pharmaceutical promotional regulations and submission requirementsOur Values
        • Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.
        • Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures.
        • Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.These three values come to life through our five Leadership Expectations that apply to all Horizon employees
          • Enterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspective
          • Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sources
          • Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments
          • Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of working
          • Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their roleOur Values
            • Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.
            • Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures.
            • Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.These three values come to life through our five Leadership Expectations that apply to all Horizon employees
              • Enterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspective
              • Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sources
              • Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments
              • Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of working
              • Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their roleAt Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better. Horizon intends that all qualified applications are given equal opportunity, and that selection decisions be based on job-related factors. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristics protected by law.

Keywords: Horizon Therapeutics, Arlington Heights , Specialist/Senior Specialist , PRC, Other , Deerfield, Illinois