AbbVie

Director, Regulatory Affairs Data Standards and Governance

AbbVie • $150K — $180K *
North Chicago, IL 60064In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in life sciences (pharmacy, biology, chemistry, medical technology pharmacology)
  • 6 to 8 years in regulatory affairs, R&D or related area
  • Knowledge of ISO IDMP requirements and EU IDMP implementation
  • Experience in a complex global matrix environment
  • Strong oral and written communication skills

Responsibilities

  • Lead the Product Data Governance Office to execute effective Data Governance processes
  • Support enterprise-level data governance and improve data quality for Regulatory and Supply Chain integration
  • Collaborate with cross-functional teams to implement consistent data standards
  • Utilize AbbVie’s Data Catalogue to verify data lineage and mapping properties
  • Advocate for AbbVie’s interests in industry forums regarding regulatory standards
  • Work with EKS to build central Ontology services while incorporating external standards
  • Support the deployment and training of analysis tools for data harmonization

Benefits

  • Comprehensive benefits package including medical/dental/vision insurance
  • Paid time off including vacation, holidays, and sick leave
  • Participation in long-term incentive programs
  • 401(k) plan for eligible employees
Full Job Description
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 AbbVie's 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 AbbVie's interest in industry forums and collaborates with RPI colleagues to share knowledge learned through industry engagement and assess the impact to AbbVie's Regulatory systems and processes.
  • Ensure that AbbVie's 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 AbbVie's 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: Bachelor's 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 location,and 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, 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 anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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