• Managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks • Working closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance • Preparing for auditing activities while meeting strict deadlines • Maintaining a full study workload with minimal supervision • Establishing and maintaining a document management system for regulatory electronic files • Maintaining FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks • Ensuring all regulatory documentation is compliant with local Standard Operating Procedures (SOPs) for format and content • Maintaining critical documentation ensuring compliance • Modifying and/or developing informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA • Organizing and processing documentation for IRB submission for multiple trials • Processing of Protocol Deviations that meet the IRB reportable criteria • Submitting urgent safety notifications to the IRB • Other duties as assigned

• Serve as the Engineering technical contact for annual SOX, SOC2 Type II, and ISO-27001 audits while automating evidence collection into Continuous Compliance workflows with minimal disruption to engineering velocity. • Work with DevOps Engineers to implement Compliance as Code, establishing automated guardrails and performing internal reviews of infrastructure configurations. • Manage the technical lifecycle of user access, enforce Segregation of Duties (SoD), and review deprovisioning workflows to ensure compliance with security policies. • Support GRC teams by providing technical expertise during sales cycles, responding to RFPs, and maintaining the Security Trust Center and compliance documentation.

• Advise customers on information security policies, control evidence, and overall audit readiness as they prepare for audits and assessments • Lead end-to-end control mapping and cross-framework crosswalk analysis • Serve as the primary compliance expert in customer-facing meetings • Lead the development and present on GRC industry best-practices and on common compliance questions received from customers • Lead ongoing internal learning and success of our team by sharing knowledge through mentorship, research, and internal presentations. • Partner with Customer Success and Account Managers in providing current customers with additional compliance advisory services as needed. • Engage with the Sales team, as needed, with responding to prospective customer questions. • Host customer-facing webinars to answer questions on audit and GRC best practices • Review marketing articles and blog posts for accuracy as needed.

• Manage incoming security questionnaires and customer assurance requests and assessments end-to-end, coordinating with Engineering, Security, and other internal stakeholders to provide accurate, timely responses • Maintain and update the customer assurance knowledge library and trust center documentation to ensure content is current and accurate • Review incoming contracts and identify compliance-related requirements, obligations, or risks, escalating findings to Legal as appropriate • Support the development and maintenance of reusable response frameworks and standard documentation to improve the efficiency of the customer assurance process • Execute recurring compliance activities within assigned control domains, including evidence collection cycles, control attestations, and scheduled review tasks • Manage findings and evidence renewals in the GRC platform, ensuring controls remain current and audit-ready • Daily monitoring of compliance IT solutions for the identification and resolution of out of compliance end users, devices, and other company assets • Contribute to the development, review, and maintenance of company policies, security controls, and supporting documentation • Support the preparation for and completion of internal and external compliance audits, including evidence gathering and auditor coordination within assigned scope • Stay current on the evolution of relevant compliance frameworks and communicate changes to team members and leadership • Perform vendor due diligence and compliance reviews for vendor evaluation requests, documenting findings and requirements in relevant systems • Coordinate with SecOps to review vendor risk findings and track remediation to resolution • Support the continuous improvement of vendor risk assessment processes and documentation standards • Stay up to date on the evolution of compliance frameworks, providing updates to team members, departments, and management when changes occur • Educate and train team members, departments, and management on security best practices that align with compliance frameworks • Additional duties as assigned