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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
The Data Governance Lead for Regulatory Affairs will be responsible for defining, implementing, and overseeing data governance strategies and frameworks within the regulatory affairs domain. Regulatory information assets are a core asset for regulatory affairs and the broader enterprise at Gilead, this leader will ensure data integrity and quality expectations are embedded into the ways of working within the organization. This role ensures compliance with global regulatory data requirements, drives data quality initiatives, and facilitates alignment between global regulatory affairs and cross-functional teams.
The role will provide strategic input and operational leadership for data domain teams that will focus on data quality throughout the regulatory affairs organization. The incumbent will collaborate with patient safety, quality, regulatory CMC, commercial, clinical, and other development organizations on data governance activities that interfaces with end-to-end regulatory processes. The role will align and leverage broader master data management initiatives that exist within the development systems and information technology organizations. The role will lead efforts to improving our data quality through establishing authoritative datasets and leveraging innovative technologies.
You will be a member of the Innovation, Digital and External Partnerships (IDEP) Leadership Team with considerable responsibilities to develop, continuously improve and innovate global regulatory practices, processes, tools, team, and other capabilities.
EXAMPLE RESPONSIBILITIES:
Leads the Regulatory Affairs Data Governance Council and drives the overall approach for data integrity and quality for the organization.
Designs and implement a comprehensive data governance framework that is fit for purpose for Regulatory Affairs data and processes.
Accountable for driving an effective and integrated cross functional data governance that crosses organizational boundaries.
Leads a matrixed team of representatives from the data domains across the organization
Define data standards, policies, and procedures to ensure consistency, accuracy, and compliance across the organization.
Act as the custodian for regulatory data, ensuring data quality, completeness, and reliability.
Ensure all regulatory data adheres to local, regional, and global compliance requirements, including FDA, EMA, and other regulatory bodies.
Partner with quality and compliance teams to stay updated on evolving regulatory standards and inspection readiness expectations, integrate needs into data quality practices.
Collaborate across Regulatory Affairs functions and Quality to establish authoritative datasets, data governance priorities and objectives.
Provide guidance to functions on data governance and stewardship best practices for their organization.
Evaluate and implement data quality management tools and technologies to improve business operations and data quality.
Drives digital innovation across the data governance activities and approaches.
Collaborate with development systems and data owners to manage system upgrades, integrations, and enhancements related to regulatory data integrity and quality.
Develop and track key performance indicators (KPIs) to measure the effectiveness of data governance initiatives.
Generate reports for senior management and functional leadership as needed on state of regulatory data.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Education & Experience
MA/MS/MBA/PharmD/PhD with 10+ years’ relevant experience.
BA/BS in Life Sciences, Information Management, Regulatory Affairs, or related field with 12+ years’ relevant experience.
10+ years’ experience in life sciences/biotech industry. Extensive experience leading data governance and stewardship capabilities in a regulated environment.
Strong experience in the domains of regulatory information and how they relate to the product development and lifecycle management activities of our portfolio (i.e. product registrations/licenses, investigational and marketing applications, submission content, label tracking, variations)
Extensive experience and significant successes establishing authoritative data assets and developing operating constructs to ensure data integrity and quality.
Strong track record of successes working and negotiating across organizations in a matrixed environment.
Experience in leading high-complexity, large-scale, cross-functional global initiatives in regulatory affairs.
Certifications in PMP, change management, or Six Sigma/Lean are a plus.
Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.
Knowledge & Other Requirements
Strong knowledge of the biopharma industry, including in-depth understanding of regulatory affairs and adjacent business functions, as evidenced by proven achievement in short- and long-range strategies, plans, and objectives.
In-depth knowledge of systems, tools, metrics, and digital technologies to support regulatory affairs and broader data governance (i.e. Veeva, Docubridge, Collibra, Informatica)
Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH).
Knowledge of data privacy regulations (e.g., GDPR, HIPAA) and their implications for regulatory data management.
Demonstrates ability to rapidly become acquainted with Gilead’s current ways of working and data quality approaches.
Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications.
Proven ability to influence up, down, and across the organization and externally in a collaborative manner.
Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans, and strategic objectives.
Advanced meeting facilitation, organizational, and communication skills.
Strong negotiation and conflict resolution skills.
When needed, ability to travel.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
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