Sr Manager, Clinical Trials Compliance and Standards

Company: Horizon Therapeutics
Location: Evanston
Posted on: March 12, 2023

Job Description:

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 Summary:The Senior Manager, R&D Compliance and Standards must have experience in Clinical Trials and is a model of regulatory and quality systems compliance and should function as a subject matter expert and advisor to his or her colleagues throughout the organization.The Senior Manager, 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 Manager, 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 of the responsibilities and tasks listed below.Responsibilities:The expectation is the that Senior Manager, R&D Compliance and Standards is able to perform the following responsibilities and tasks independently, with minimal direction from management:Develops and maintains quality systems and controlled documentsReviews R&D documents and provides input from a compliance and standards perspectiveMaintains documentation and tracking of Compliance and Standards activities and communicationsCreates tools and training material to support R&D functionsPlans, arranges, and/or conducts internal and external auditsManages partner audit/regulatory inspection readiness and audits/inspectionsTracks and communicates vendor Key Performance Indicators (KPIs) and other R&DCompliance metrics across the organizationPlans and conducts root cause investigations and analysesManages CAPAs including those arising from deviations and incidentsAs assigned, manages, directs, or mentors, R&D staff, and consultants or contractorsUnderstands and works to a risk-based approach, prioritizing the safety and welfare of human trial participantsAbility to travel independently up to 20% over the course of a yearQualifications and Skills Required:Bachelor's Degree, preferably in healthcare or clinical research5+ years of experience in medical product research and developmentClinical Trials experience preferred Previous experience in a GCP and/or GVP role preferredAbility to work under pressure and maintain flexibilityAttention to detailKnowledge of 21 CFR 11, SO, 54, 56, 58, 312, and 812 as well as ICH E6R2Strong analytical skillsProficient in Microsoft OfficeProfessional, proactive demeanorStrong interpersonal skillsStrong written and verbal communication skills#LI-REMOTE Our ValuesTransparency: 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 employeesEnterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspectiveExhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sourcesEnsure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitmentsEmbrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of workingDevelop Talent: Provide feedback, coaching and mentorship to help others be more effective in their roleCompensation and Benefits Summary:The salary range for this role is $135,000.00-$165,000.00 annually. The base salary offered may vary based on the final candidate's qualifications. The level of this role may also change based on the final candidate's qualifications.In addition to the salary, this position is eligible for the benefits listed here and for the following plans:Salary Plan, Annual Merit Plan, Annual Equity Grant, New Hire Equity Grant, Corporate BonusAt 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, Evanston , Sr Manager, Clinical Trials Compliance and Standards, Executive , Evanston, Illinois