Elena Shturman, Ccep-I (She/Her/Hers) Email & Phone Number

Sunnyvale, California, Us

Developing and leading all aspects of Ceribell's corporate and healthcare compliance program.Creating foundational policies and processes to ensure regulatory compliance.Chair of the Compliance Committee, driving compliance strategy and oversight.Supported the company’s successful transition to a public entity by aligning compliance with business goals.Focus: Building a scalable, effective compliance program that fosters a culture of integrity and supports growth in the medtech space.

South San Francisco, Ca, Us

Develop the Compliance Department and implement support during the commercialization of the FDA approved leading therapeutic product for a publicly traded biopharmaceutical company developing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases.• Partner with Chief Compliance Officer to develop the Compliance Program strategy• Develop Policiies, Training Plan, Auditing and Monitoring Program• Implement a Hotline• Partner with Sales and Marketing teams to support Speaker Beaureau and HCP engagements programs

Austin, Texas, Us

Identified risk, developed the Compliance Department and implemented support for the scaling of COVID-19 testing and COVID-19 vaccinations during the COVID-19 pandemic of a privately held medical device, CLIA laboratory and healthcare provider company operating throughout the United States. • Partnered with the General Counsel to perform a gap assessment analysis of the Compliance Program.• Developed and implemented a Code of Conduct and Business Ethics.• Developed Healthcare Compliance Policies.• Partnered with CLIA lab, HR, Regulatory and National Sales Team.

Lawrence Township, Nj, Us

Worked with BMS integration and Legal teams to ensure a smooth transition, knowledge retention, and business continuity for a global biopharmaceutical company headquartered in New Jersey (US) aspiring to transform patients’ lives through science. MyoKardia sits within BMS’ Cardiovascular focus area.• Served as co-chair of COVID-19 Return to Site Task Force.• Acted subject matter expert on COVID-related regulations, compliance pitfalls and return to site strategy. • Partnered to HR, Facilities, EHS, Finance and Executive Team.• Acted as post-NDA filing FDA Inspection Readiness team member and Financial Disclosures subject matter expert.• Supported HCP engagements due diligence process.• Managed MyoKardia FINRA, SEC, and other government inquiry-related internal investigations.• Continued to provide interim risk assessment of MyoKardia functions.

Brisbane, California, Us

Identified risk, developed the Compliance Department and implemented support during the commercialization of the leading therapeutic product for a clinical-stage publicly traded biopharmaceutical company developing medicines for the treatment of rare cardiovascular diseases. • Served on COVID 19 Task Force co-chair, engaged in compliance and legal strategy planning for COIVD 19 return to site process. Serve as an expert on laws and state-specific rules and regulations. Consult and collaborates with departments on compliance review of pandemic-related risk assessment.• Created strategy for Compliance Department growth and development.• Continuously identified opportunities for process improvements in managing cross-functional and department needs, implement procedures and technology to maintain momentum for operational efficiencies created with the enterprise and compliance department.• Supported NDA filing and inspection readiness projects.• Managed contracts and document forensics.• Investigated potential violations of policy, regulations and standards of conduct and coordinated with management in implementing corrective action plans.• Created tools that can support diverse business functions and complex interdepartmental data sharing.• Implemented and served as an administrator of a Hotline.

Sacramento, California, Us

Served as an expert on healthcare compliance for the Company, providing education and training on HIPAA, fraud and abuse laws, including the Stark Law, Anti-Kickback Statute, Federal False Claims Act, global privacy laws and state-specific rules and regulations for a multinational privately held corporation that built healthcare communities through partnerships with government, research institutions, and private organizations. • Ensured internal policy compliance with State and Federal laws.• Delivered compliance support across organization working with colleagues in marketing, research, clinical, regulatory, finance, and other departments to identify practical solutions that balance the risk/ benefit for the company.• Increased revenue by $50 million annually with creation of Speech Therapy Department. Strategized to negotiate contracts with HCPs and HCOs, global specialists in the field.• Achieved business growth by developing compliance culture internal policy analysis and business continuity strategies.

Served in an elected capacity as Vice President with corporate governance responsibilities requiring maintenance of registrations, bylaws, and policy development.• Developed and maintained an up-to-date Corporate Governance and Conflict Resolution Policy, created Contract templates for various commercial agreement types between UNA – USA chapters, various vendors and donor corporations.• Planned more than a dozen successful fundraising projects annually, met objectives, developed contingencies, and managed resources within budget.• Worked closely with US and foreign officials and representatives, in cross-functional teams, to co-host International Events aimed at promoting United Nations Millennium Goals and influence US / UN foreign policy

Bonn, North Rhine-Westphalia, De

Worked with multiple specialized agencies within the United Nations system, such as UNDP, UNESCO and United Nations Volunteers. Facilitated growth of sustainable human development-oriented projects by focusing on detailed legal research and review, effective online communication and collaboration with international cross-functional teams.• Created and Translated volunteer law, outlining volunteer rights, responsibilities and protection for volunteers while performing volunteer work for the United Nations in Kyrgyzstan.• Developed a database of codes, treaties, case law and other resources available to lawyers throughout the world for Defense Wiki, an International Criminal Defense online legal research library.• Reviewed, analyzed and created Corporate Governance Documents for Non-Profit Corporations working with United Nations, to make sure they meet international standards.• Refined relationship-building skills and experience working collaboratively with multi-national range of corporations and government representatives.

Paralegal Studies

Doctor Of Law - Jd, Law

Certificate, Healthcare Law

Liberal Arts And Sciences, General Studies And Humanities