All Professionals
Overview
Sarah Volden is a director in the Life Sciences Consulting Group at Paul Hastings, based in the firm’s Palo Alto office. Sarah has over 17 years of experience leading global compliance programs for pharmaceutical, biotech, medical device and digital health companies. Blending consulting and in-house experience, she has assisted teams in navigating regulatory ambiguity to mitigate risk while still enabling teams to meet strategic business objects when building, designing and operationalizing compliance programs. She possesses extensive experience advising and managing across the elements of an effective program, including: risk assessments, written standards, training and communication, governance and oversight, third party management, and monitoring and auditing.
Education
- University of California, Los Angeles, B.S. (Science, Computer Science and Engineering)
Representations
- Led the redesign of a large pharmaceutical company’s monitoring program across live, transaction and email review; engagement involved aligning global and U.S. requirements and reporting, developing key risk indicators to select samples, enhancing testing attributes and implementing a consistent governance and remediation framework.
- Oversaw and owned all elements of the compliance program for a digital health company through various phases of program and company maturity, including investigations, monitoring, transparency, policy governance and third-party management.
- Managed several compliance program assessments for pharmaceutical, biotech, medical device and digital health companies; defined compliance program strategy and roadmap for companies of varying size, maturity and scope (e.g., global, U.S.).
- Owned compliance governance and executive reporting, including managing and presenting to the compliance committees and facilitating compliance board reporting.
- While in-house, advised sales, marketing, medical, clinical and user experience research on complex and ambiguous legal and regulatory requirements.
- Ran a digital health company’s risk assessment program that had to navigate an ever-changing product portfolio and business focus; developed the company’s risk strategy and approach; assembled and managed a cross functional risk management and mitigation team comprised of regulatory, clinical, security, privacy, commercial; presented regularly to senior leadership.
- Supported a risk assessment engagement for a large multinational company focused on compliance with anti-bribery anti-corruption, trade compliance, anti-money laundering and sanctions laws and regulations.
- Designed and implemented fit-for-purpose global compliance processes focused on company interactions with healthcare professionals for several pharmaceutical and life sciences companies.
- Established a third-party risk management program that integrated anti-bribery anti-corruption, security, privacy, regulatory, quality and clinical components.
- Created training and awareness materials for a pharmaceutical company’s anti-bribery and anti-corruption due diligence program.
- Led multiple engagements to assist companies in policy and procedure design, creation and rollout.
- Managed an engagement to develop a large pharmaceutical company’s global healthcare compliance policy framework; defined global policies and local annexes to meet all local country requirements.
- Conducted a Health Insurance Portability and Accountability Act (HIPAA) assessment to prepare an organization for potentially becoming a covered entity; reported key recommendations to executive leadership risk committee; enhanced policies and procedures to meet regulatory requirements.
- Led numerous engagements related to spend transparency across state, federal and global jurisdictions; defined and implemented company strategies/operating models for spend transparency reporting across people, process and technology.
- Recruited to Switzerland to build a virtually ground-up network for pharmaceutical and life sciences healthcare compliance specialists across multiple European markets.