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The MQA Compliance Specialist investigates quality nonconformances, reviews and approves CAPAs and change controls, and ensures compliance with local and federal regulations. Key responsibilities include reviewing documentation, conducting inspections, and collaborating with functional groups to improve processes.
The Senior CQA Specialist is responsible for managing Change Control and CAPA records, authoring Quality Agreements, participating in audits, and ensuring regulatory compliance at the Raleigh facility. This includes developing compliance systems, facilitating self-inspections, and supporting multi-functional project teams.
The Patent Counsel will develop and implement strategies to secure and protect Indivior's intellectual property, manage patent portfolios, draft and prosecute patent applications, and support the R&D organization through client counseling and risk analysis. The role requires interaction with various business areas and support in patent litigation.
The Senior Rebate Analyst is responsible for managing State Medicaid and Commercial payor contracts, processing rebates, and analyzing utilization and rebate trends. They collaborate with various teams to ensure compliance and timely payments and continuously maintain knowledge of regulations affecting rebate contracting.
The Manager, Quality R&D Operations will lead a team to ensure adherence to quality systems for the development and delivery of investigational medicinal products, manage the quality management system, host regulatory inspections, and ensure compliance with cGMPs in support of clinical trials. Collaboration with cross-functional teams to resolve GxP related issues is also a key responsibility.
The Head of Executive Compensation and Equity Plans will oversee the strategy and administration of the Group's share plans, support remuneration disclosures, assist in executive compensation matters, and collaborate with various internal and external stakeholders to enhance compensation and benefits design.
The Senior Manager/Manager, Peer to Peer Marketing Lead will coordinate external speaker engagements, ensure compliance with regulations, manage budgeting, develop marketing content, and assess program performance. This role requires collaboration across various functions and innovation in peer-to-peer strategies, focusing on advancing awareness and education about substance use disorders.
The Strategic Communications Specialist will develop and manage communication strategies and content for various platforms, ensuring brand consistency while overseeing production projects. Key responsibilities include managing the editorial calendar, coordinating town hall communications, and maintaining internal and external channels.
The Lead Scientist in Module 3 Dossier Development will write, review, and approve regulatory submission documents, support the development and maintenance of dossiers throughout the project lifecycle, ensure compliance with ICH and local regulations, and actively engage in stakeholder interactions and continuous improvement initiatives.
The Integrity & Compliance Global Analytics Lead will create and implement analytic strategies for the Indivior Global I&C Program, generating insights and standardized tools while improving compliance metrics through data analysis and BI solutions. Responsibilities include managing data sets, designing BI reporting systems, and ensuring data quality.
The Aseptic Operator I is responsible for operating and monitoring aseptic processing and test equipment, ensuring compliance with cGMP and SOPs. Duties include cleaning and maintaining equipment, adhering to safety and quality standards, and completing required documentation.