When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Great opportunity to bring your regulatory labeling operations and analytics expertise to Parexel!
We are seeking a strategic Senior Regulatory Affairs Associate, Global Labeling Compliance Analytics professional to join a large, dedicated client partnership and lead data and metrics-driven end-to-end (E2E) labeling compliance oversight. This pivotal role encompasses KPI design, analytics, reporting, data integrity, and governance support. The successful candidate will provide critical visibility into E2E labeling process health while supporting compliance forums, audits, and digital enablement initiatives. Cross-training in key process management responsibilities ensures backup coverage and operational continuity.
Key Responsibilities
Data, Metrics & Analytics Leadership
- Design, manage, and report E2E labeling metrics and KPIs; identify trends, risks, and improvement opportunities
- Maintain the Global Labeling Monitoring & Evaluation Plan and develop new metrics for E2E process health
- Build dashboards and analytics using Power BI, Excel, and pivot tables
- Lead cross-functional alignment on metric definitions, oversight expectations, and reporting cadence
- Prepare slide decks for Compliance Councils and governance forums and track follow-up actions to closure
Compliance Governance & Forums
- Support Global Labeling Compliance E2E Compliance Meetings, PSMF inputs, PCC, and other compliance governance activities
- Manage Pharmacovigilance aggregate report scheduling until transition is complete
- Provide analytics-based insights to strengthen regulatory and compliance decision-making
Data Oversight, Quality & Digital Enablement
- Monitor, validate, and analyze data relevant to labeling implementation and oversight
- Prepare audit/inspection evidence and escalate data integrity issues as needed
- Support digital enablement initiatives, including data model improvements and process automation
- Uphold standards for data quality, integrity, and traceability
Process Management & Change Support
- Support process updates (e.g., Veeva-related changes) and evaluate downstream process impact
- Align with Veeva COP workflows, system handoffs, and system-to-process dependencies
- Cross-trained on key process management and Global Labeling training tasks for operational continuity and to provide backup coverage
Project & Cross-Functional Support
- Contribute to data-driven and compliance reporting projects (e.g., GRA Data Cockpit, data integrity initiatives)
- Provide analytic insights to upstream and downstream partners across functions
Audit & Inspection Support
- Prepare and review data-driven audit materials, ensuring accuracy and data integrity
- Support maintenance of an audit-ready state and continuous improvement of audit processes
Skills & Experience required for the role:
- Bachelor's degree in Life Sciences, Pharmacy, Data Analytics, or related field
- Strong grasp of E2E labeling process and the interdependencies with Regulatory, Pharmacovigilance, and Manufacturing functions
- Experience in compliance governance, KPI oversight, and supporting audits/inspections
- Solid grounding in deviations, CAPA, audits, ALCOA+ principles, and process management
- Hands-on experience with Veeva RIMS, TrackWise, QDocs, Documentum and regulatory data structures
- Advanced Excel (pivot tables, formulas, analytics) and Power BI (dashboards, visualization) experience
- Strong analytical capability with ability to translate data into clear insights and actionable CAPAs
- High standards for data quality, integrity, and traceability
- Excellent communication, organization, and cross-functional collaboration skills
- Experience working with Senior Leadership and presenting to executive audiences
- Project management certification or experience (preferred)
- Fluent in English, written and spoken
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
