Data Governance - Compliance Specialist - job 1 of 2

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

The Data Governance – compliance specialist is vital to ensuring robust governance of consent and sample management for both primary and secondary sample uses across QM&G. This role is responsible for reviewing and optimizing Informed Consent Forms (ICFs), overseeing sample collection, retention, and withdrawal of consent processes, and ensuring adherence to all relevant internal and external regulations. The specialist collaborates closely with Legal, R&D, and QM&G teams to coordinate cross-functional governance projects, facilitate continuous process improvement, and drive operational excellence in sample governance. Additionally, the role provides critical operational and project support across various governance initiatives, aiding in the planning, coordination, and execution of these projects, including support for secondary use sample request across R&D in GOV360. By fostering strong collaboration between departments, contributing to process enhancements, and ensuring that governance activities align with organizational goals and compliance requirements, the specialist plays a key role in the success and integrity of governance operations.

Key Responsibilities:

• Governance Process Support:
  • Critically review, edit, and optimize ICFs and consent documentation for regulatory compliance and sample management transparency.
  • Assist in designing and improving processes/procedures for sample collection, retention, withdrawal of consent (WoC), and disposition, ensuring alignment with organizational policies and participant rights.
  • Ensure alignment cross function on language and strategy on sample collection.
• Operational Coordination:
  • Coordinate cross-functional governance initiatives, collaborating with Legal and R&D to resolve protocol and or ICFs issues, implement best practices, and integrate consent and sample management across functions.
  • Track and report project milestones, identify gaps, and support corrective actions and process improvements.
  • Support Gov360 Sample request and processes.
  • Support cross functional governance projects.
• Technical and Analytical Support:
  • Leverage relevant platforms or tools to document, track, and analyze consent and sample lifecycle data, ensuring traceability and audit/preparedness.
  • Support data integration for operational planning and reporting needs.
• Training and Guidance:
  • Develop and deliver training for internal stakeholders on regulatory requirements, SOPs, and governance best practices related to consent/sample management.
  • Serve as a point of contact for operational and compliance inquiries.
• Performance Monitoring and Reporting:
  • Monitor compliance metrics, key performance indicators (KPIs), and prepare governance reports for leadership and stakeholders.
• Continuous Improvement:
  • Identify and drive initiatives for process harmonization, risk mitigation, and operational efficiency across all aspects of sample and consent governance.

Qualifications:

• Bachelor’s degree or above in life sciences, health law, business administration, regulatory affairs, or related field.
• 4+ years' experience in clinical research governance, protocol/sample management, or operations support, preferably with hands-on ICF and sample workflow exposure.
• Deep understanding of regulatory standards (GCP, GDPR, HIPAA) and sample/consent documentation requirements.
• Proficiency in analytical platforms and documentation tools.
• Strong organizational, interpersonal, and communication skills with demonstrated cross-functional collaboration.

Preferred Qualifications:

• Experience working in biopharmaceutical, clinical research, or integrated governance environments.

Key Competencies:

• Attention to Detail: Ensure thoroughness and accuracy in complex compliance documentation and process execution.
• Analytical Thinking: Use regulatory and operational data to inform decisions and process improvements.
• Collaboration: Work effectively with multidisciplinary teams to drive governance integration and compliance.
• Initiative: Proactively identify system/process gaps and propose solutions to enhance governance practice.

Key Stakeholders 

Scientific Compliance group, Metrology, Discovery, Development Science staff, Clinical Manufacturing & Operations

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 ofthis posting 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 short-term incentive programs. ​

• 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 anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand 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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