Director, Regulatory Affairs Data Standards and Governance

Responsibilities

• Demonstrates leadership within the Product Data Governance Office, building and executing lean and effective Data Governance processes.
• Support the Product Data Office initiative to establish enterprise-level data governance, improve data quality and interoperability to resolve key business challenges including Regulatory and Supply Chain data integration and Change Control processes.
• Through Data Office engagement, works with cross-functional colleagues to define and implement consistent processes for data standards implementation across AbbVie.
• Builds and uses AbbVies Data Catalogue to drive clear definitions for critical data elements, supporting data lineage verification and mapping properties across systems for interoperability of Regulatory data across the product lifecycle.
• Demonstrates detailed knowledge of ISO IDMP requirements, and how the ISO IDMP standard is being implemented by Health Authorities globally. As an IDMP SME, advocate for AbbVies interest in industry forums and collaborates with RPI colleagues to share knowledge learned through industry engagement and assess the impact to AbbVies Regulatory systems and processes.
• Ensure that AbbVies interests are represented in external industry forums for cloud-based submissions, structured data submissions, eCTD4, structured content authoring and the implementation of Regulatory industry standards.
• Prepare AbbVie for the implementation of regulatory requirements on data submission topics to ensure sustained compliance with Health Authority requirements.
• Collaborates with EKS (Enterprise Knowledge Services) to build AbbVies central Ontology services for Regulatory and Enterprise use, incorporating external standards published by organizations including ISO, WHO, ICH and Health Authorities.
• Supports the rollout, implementation and training of analysis tools which aid comparison of AbbVie system dictionary terms and data to enterprise standards maintained in the Ontology to support cross-system and cross-functional data harmonisation, remediation and synonym matching.
• Engages with and communicates on data enrichment and harmonisation projects linked to system interoperability projects thus driving overall awareness.
• Support consistent data entry within COSMOS RIM by monitoring and maintaining system dictionaries and vocabularies in alignment with enterprise standards to support data submissions, FHIR projects and, to prepare AbbVie to meet Regulatory compliance e.g. EU IDMP.
• Work with RIM colleagues to deliver COSMOS system releases that drive further automation, functionality, and data optimization using new technologies.
• Collaborate with RIM colleagues to define enhancements and improvements to COSMOS and Hubble configuration and processes.
• Support communications and training rollout to ensure adoption of consistent processes and best practices to drive data quality improvements.
• Update COSMOS system dictionaries and vocabularies to accommodate external standards and define and implement internal, AbbVie standards to support consistent data entry and reporting.
• Manage and monitor COSMOS dictionaries and vocabularies in alignment with Ontology values and drive automation to reduce the burden and risk of manual data entry.

Qualifications

• Required Education: Bachelors degree in pharmacy, biology, chemistry, medical technology, pharmacology, or related life sciences.
• Required Experience: 6 to 8 years in regulatory affairs, R&D or related area.
• Knowledge of ISO IDMP requirements, EU IDMP implementation requirements and external organizations promoting regulatory data standards e.g ISO, WHO, FDA, EMA.
• Experience working in a complex global matrix environment with diverse team members.
• Good communication, both oral and written.

Additional Information

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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