Datavant · 3 hours ago

Director, Life Sciences Compliance

Remote, United States

Full-time

Remote

Director/Executive

$165K/yr - $245K/yr

8+ years exp

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BiopharmaClinical Trials

No H1B

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Responsibilities

Design, implement, manage, and report Datavant’s GCP compliance program, ensuring adherence to regulatory requirements and industry best practices.

Provide strategic guidance to senior leadership on compliance-related business decisions.

Maintain a deep understanding of the Common Rule, data privacy requirements, GCP, ICH guidelines, and 21 CFR Part 11 to ensure Datavant clinical data, processes, and systems comply with relevant laws.

Serve as the primary compliance liaison with life sciences partners, regulatory bodies, and auditors.

Lead strategic compliance initiatives and risk assessments across the organization's life sciences activities, with support from the Chief Compliance and Privacy Officer.

Direct the development and implementation of compliance policies, procedures, and training programs to ensure organizational adherence to regulatory requirements.

Lead preparations for and responses to audits and inspections, ensuring the company's readiness and compliance.

Lead the development and execution of Corrective and Preventive Actions (CAPA) to address any identified compliance gaps or deficiencies, ensuring timely resolution.

Collaborate with Sales, Legal, Technology, and other critical internal stakeholders to review, update, and improve policies, procedures, processes, systems, and agreements to align with GCP and other applicable requirements.

Develop and manage GCP training programs for internal teams to strengthen understanding of compliance requirements.

Identify areas of non-compliance or risk and develop mitigation plans.

Partner with internal audit function to monitor compliance and drive continuous improvement.

Ensure the proper maintenance of documentation in compliance with GCP standards, including protocols, procedures, and audit trails.

Lead impactful efforts with a hands-on approach, ensuring high-quality execution.

Serve as a strong communicator, coach, and mentor within the organization.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical Practice (GCP)21 CFR Part 11Compliance managementRelevant certificationsHealth information technologyData analyticsProgram managementProject managementInternational regulatory complianceMatrix organization experienceRisk assessmentTraining developmentAudit preparationPreventive Actions (CAPA)Cross-functional experienceMentoring