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Manager, Clinical Trials Compliance & Standards

Company: Horizon Pharma
Location: Deerfield
Posted on: November 20, 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 Manager, R&D Compliance and Standards 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 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 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: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 functionsWith direction, plans, arranges, and/or conducts internal and external auditsWith oversight, manages partner audit/regulatory inspection readiness and audits/inspectionsTracks and communicates vendor Key Performance Indicators (KPIs) and other R&D Compliance metrics across the organizationWith support, plans 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 research4+ years of experience in medical product research and developmentPrevious 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 skillsHorizon Core Values & Competencies: GrowthManages AmbiguityStrategic MindsetDemonstrates Self-awarenessCultivates InnovationDevelops TalentAccountabilityDrives ResultsEnsures AccountabilityDecision QualityTransparency CourageCollaborationInstills TrustHorizon 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.SummaryLocation: Deerfield, ILType: Full time

Keywords: Horizon Pharma, Arlington Heights , Manager, Clinical Trials Compliance & Standards, Executive , Deerfield, Illinois

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