Regulatory Data Steward

Job not on LinkedIn

October 22

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $137k - $215.3k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Takeda

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Takeda is a global biopharmaceutical company dedicated to bringing better health and a brighter future to patients worldwide. With a strong focus on research and development, manufacturing, and quality, Takeda operates with a commitment to ethics and a diverse workforce that spans over 80 countries. The company leverages innovative science and partnerships to create impactful medicines, including therapies in oncology and vaccines, ensuring that they effectively meet the needs of the patients they serve.

10,000+ employees

Founded 1781

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Grant on 2016-08

📋 Description

• Monitor, profile, and analyze regulatory data to ensure compliance with defined standards and design specifications (source-to-target validation). • Perform data quality analysis, error detection, documentation, and correction across diverse platforms (SQL, Excel, Informatica, Veeva Vault, third-party applications). • Investigate, troubleshoot, and document data issues raised by internal and external stakeholders. • Support root-cause analysis of data issues and recommend process and system improvements. • Implement data governance policies, standards, and SOPs in partnership with Regulatory Data Owners. • Define and maintain data quality controls, metrics, and dashboards within data catalogs and reporting tools. • Ensure processes, methodologies, and metrics are consistently applied to maintain and improve data quality. • Identify and escalate regulatory and legal risks related to data issues, ensuring timely resolution. • Maintain awareness of evolving international regulatory requirements (e.g., IDMP, SPOR, XEVMPD, eCTD, ePI, PQ/CMC, CTIS, ESMP) and assess their impact on RIM data. • Act as liaison between Data Owners, Business Process Owners, IT, and external vendors to ensure alignment on remediation and quality improvements. • Participate in cross-business unit forums to resolve data definition, production, and usage issues. • Communicate data quality concerns, escalations, and risks to stakeholders and governance forums in a clear and actionable manner. • Establish, monitor, and report on Service Level Agreements (SLAs) with external vendors performing data stewardship and quality assurance activities. • Ensure external partners deliver consistent, compliant, and high-quality data services aligned with regulatory expectations. • Define processes and frequencies for metadata reconciliation and discrepancy resolution. • Recommend and implement new controls, process enhancements, and automation opportunities to improve data quality. • Support integration of new data assets from M&A, system migrations, or external regulatory sources into RIM.

🎯 Requirements

• 5+ years of experience in the healthcare/pharmaceutical industry. • 5+ years of experience in data management or data governance roles, ideally in a regulatory context. • Bachelor’s degree in Life Sciences, Pharmacy, Data Science, Information Management, or a related field required. • Master’s degree in Regulatory Affairs, Data Management, or related discipline preferred. • Strong expertise with the Veeva RIM data model and regulatory metadata management. • In-depth understanding of regulatory data standards (IDMP, SPOR, XEVMPD, eCTD, etc.). • Strong analytical and problem-solving skills, including root-cause analysis and remediation. • Hands-on experience with SQL, Excel, and reporting/visualization tools (Power BI, Tableau, or equivalent). • Experience working in GxP environments and familiarity with data privacy regulations. • Ability to work independently with minimal oversight, while influencing diverse stakeholders. • Excellent communication skills, with the ability to translate technical data concepts into business terms. • Experience with regulatory domains such as Labeling, CMC, and broader Regulatory Affairs processes. • Exposure to public and hybrid cloud environments.

🏖️ Benefits

• U.S. based employees may be eligible for short-term and/ or long-term incentives. • U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. • U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.