Director, Regulatory Affairs Data Standards and Governance

The Director Regulatory Affairs Data Standards and Governance is responsible for driving awareness and implementation of data standards and associated best practices in systems to support Regulatory Requirements for data submissions and to enable Regulatory data to connect with data sourced from other functions including R&D Development Supply Chain Operations and Quality Assurance. This role has functional responsibilities within RIM in addition to performing a key role within the cross-functional Enterprise Product Master Data (EPMD) Data Office initiative.

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. Accomplished by building detailed knowledge of external standards applicable to Regulatory business processes and submissions including:
  • EMA standards (published through the SPOR platform)
  • FDA Data Standards Catalogue
  • World Health Organization (WHO) for ATC Codes and INN
  • International Conference on Harmonization (ICH)
• 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) 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

Preferred Experience:

• Experience working with electronic regulatory submissions and data standards prior experience in a regulatory affairs strategy role preferred
• Experience with large cross-functional master data governance projects
• Interest in advocacy as an AbbVie representative in industry forums related to the global implementation of IDMP standards data submissions and ePI and related technology collaboration with RPI
• Interest in a business SME role in Regulatory business applications and development collaborating with BTS functions

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand we may ultimately pay more or less than the posted range. This range may be modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our long-term incentive programs. 

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 commissionincentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless anduntil paid and may be modified at the Companys 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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Work :

No

Employment Type :

Full-time