Assistant General Counsel, Privacy & Regulatory

Overview

The Assistant General Counsel - Privacy & Regulatory will work closely with members of the Legal and Compliance Teams in the drafting, implementing, and overseeing the organization's global privacy, regulatory, and legal compliance programs. This individual enables adherence to applicable laws and regulations, including data privacy laws (e.g., HIPAA, CCPA, GDPR, etc.), industry regulatory standards (CLIA, NYS), and internal policies to mitigate risk and protect organizational integrity.

Responsibility

• Serve as subject matter expert and internal escalation point for privacy and data protection issues in contracting, sales and marketing, business development and operations.
• Ensure the organization has appropriate privacy contract provisions, including DPAs, Business Associate Agreements, Standard Contractual Clauses and Transfer Impact Assessments, if and as required.
• Monitor developments in data protection, regulatory, and privacy laws applicable to advanced diagnostics, and develop and lead cross functional project teams to support company compliance.
• Provide practical legal advice on data driven projects while anticipating and navigating regulatory and privacy considerations. This includes advising on issues related to data sharing and analytics, mobile applications, and use of artificial intelligence.
• Participate in the review of customer-facing materials for alignment with applicable data protection and privacy policies, laws, and regulations.
• Oversee and provide legal advice on privacy incident and breach response program.
• Provide legal advice on the use of technology within the organization (i.e. enterprise digital marketing, websites, etc.).
• Partner with Information Security, Governance/Risk/Compliance (GRC), and Government Affairs on diagnostics regulatory oversight (FDA/CLIA etc.), privacy and cyber related policy/regulation impacting the company.
• Create and/or assist with privacy operations management, including, where applicable, DSARs, data mapping, data inventory, records of processing activities, DPIAs and PIAs.
• Provide legal advice to support compliance with HIPAA, GDPR, global privacy regulation, and state genetic testing, data breach notification, regulatory and privacy laws.
• Provide support for human subject research, IRB protocol, and informed consent review in compliance with the Common Rule and Clinical Trial Regulations.
• Provide privacy and regulatory advice in research and commercialization collaborations and M&A transactions and integrations.
• Assist in special projects and other duties as assigned.

Qualifications

• Juris Doctor degree and bar admission in good standing required, License in Utah preferred or ability to obtain Utah license upon hire.
• 7-10 years of law firm or in-house legal practice with a minimum of 3-5 years in a role focused on privacy, regulatory compliance, and risk management.
• Deep understanding of and demonstrated experience working with HIPAA/HITECH, the Common Rule, GDPR, CAN SPAM/TCPA, 21^st Century Cures Information Blocking Rules, state comprehensive privacy laws (including CCPA) and emerging US state and global privacy laws.
• Experience in the diagnostics industry and working knowledge of CLIA and state regulations related to laboratory developed tests is strongly preferred.
• Strong business sense coupled with the ability to provide practical legal advice.
• Thorough organizational skills, and resourceful self-starter with excellent problem-solving capabilities, judgment, communication (written and verbal) and interpersonal skills.
• Ability to work collaboratively with cross functional teams and provide clear, concise and actionable legal advice.
• Understanding and adherence to legal ethics and ability to maintain confidentiality.

Physical Requirements

Lifting Requirements - sedentary work or exerting up to 10 pounds of force occasionally. Physical Requirements - stationary positioning, moving, communicating, and observing. Use of equipment and tools that are necessary to perform essential functions of the job.

EEO

We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.

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