Regulatory Data Excellence & Integrity Lead

Reports to Head, Regulatory Data Vanguard (RDV) and accountable for the oversight & execution of global data management activities spanning multiple regions, products etc. in support of new and remediation activities. Also accountable for the overall integrity and quality of Pfizer Global regulatory data through the oversight of data quality, completeness and timeliness, working in close partnership with the relevant BPO’s to inform procedural and process updates.

Accountable for measuring, experimenting and driving GRS towards data excellence through innovation and improvement, utilizing existing and new capabilities such as AI, data science, automations and reports in support of optimizing data quality and efficiencies for GRS.

This role will also be responsible for completing, overseeing, or supporting strategic initiatives identified by GRS in support of progressing/evolving GRS Data management. Typical projects can include working on business transformation, implementing change management, building new capabilities, increasing business efficiency efforts, re-designing complex processes or working on program management efforts for global/regional projects.

Finally, this role is responsible for liaising and influencing partner lines in the interest of safeguarding patient safety through high quality data management across Pfizer systems.

JOB RESPONSIBILITIES

Key Accountabilities:

• Accountable for the oversight of global data management activities and stewardship of Regulatory Milestones and license status conformance within regulatory systems
• Champion innovation and takes appropriate risks to challenge the status quo, resulting in enhanced processes that impact the business directions of cross functional teams and Business Units
• Influences senior management decisions that have an impact on business direction to support global regulatory data strategies across all global business units and markets
• Lead the evolution of data management & quality oversight in partnership with business and digital partners
• Ensures overall data integrity through audit and verification checks, performing quality control of timeliness, accuracy and completeness of data.
• Develop key performance indicators in order to ensure accurate and timely execution of improvement initiatives and guarantee increased compliance in relevant processes.
• Liaise with business process owners, ensuring interpretations of compliance requirements and as a key stakeholder providing input
• Establish effective and open communication with all relevant stakeholders to ensure appropriate staffing and coverage
• Coach, mentor and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities
• Demonstrated ability to effectively lead cross-functional teams and to autonomously influence business decisions where direct reporting line relationships do not exist
• Ability to autonomously influence business decisions where direct reporting line relationships do not exist
• Efficient use of resources through operational effectiveness.
• In Partnership with RIO stakeholders, e.g., business process owners, SM, Strategists, serve and co-ordinate regulatory compliance activities ensuring the timely delivery of all regulatory compliance activities across the portfolio
• Anticipates internal/external business and regulatory/ compliance issues that impact the Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit
• Serves as advisor to others across Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit
• Develops ideas and leads/co-leads complex projects across Sub Business Unit/Sub Operating Unit
• Develops and manages plans to achieve objective
• Applies skills and domain expertise to contribute to the achievement of work within Sub Business Unit/Sub Operating Unit
• Has advanced knowledge of the principles, concepts and theories in the discipline, and comprehensive knowledge of principles and concepts in other disciplines
• Makes decisions that require developing innovative options to resolve complex problems
• Makes decisions within general business line or functional guide
• Leads operational team(s) within and across Work Teams and Departments

QUALIFICATIONS / SKILLS

• Bachelor’s degree with 6 or more years or a Master's degree with 4 or more years in Life Sciences, Regulatory Affairs, Data Management, or related field.
• Strong experience in Regulatory Affairs or Regulatory Operations and data governance, data management, or data quality role.
• Proven experience managing colleagues and/or contractors within a matrix environment
• Robust understanding of biopharmaceutical industry, regulatory and safety processes, external/internal environment
• Strong understanding of global regulatory submission and compliance requirements.
• Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs ​and support compliance (e.g., Veeva RIM, Liquent, Lorenz).

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