Specialist, R&D Compliance

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 Summary: The R&D Compliance Specialist 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 R&D Compliance Specialist 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. Responsibilities: With direction and oversight from Management, the R&D Compliance Specialist: Assists with generation/revision of policies, SOPs, forms, and guidelines as assigned Manages controlled documents within Horizon's Quality Management System (QMS) Updates and/or maintains training for R&D personnel Creates tools and training materials to support R&D functions Supports partner audit/regulatory inspection readiness and audits/inspections Performs checklist driven review of R&D documents Supports site, vendor and/or internal audits and assessments Assists with vendor KPI (Key Performance Indicators) tracking and other R&D compliance metrics Supports change control, validation, and testing of R&D systems Manages RDCS email mailbox Performs other R&D Compliance support tasks as assigned Qualifications and Skills Required: Bachelor's Degree, preferably in healthcare or clinical research At least 2 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 Our 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 role At 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. Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: We apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

Salary : $56,300 - $71,200