About the Job

The Dir, Privacy Counsel supports FMI’s privacy program, responsible for advising on US and ex-US privacy laws and regulations. The position’s responsibilities include but are not limited to interpreting and assessing risk under various global data privacy laws such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA), under which FMI is a Covered Entity, the General Data Protection Regulation (GDPR), and US state laws like the California Consumer Privacy Act (CCPA). The Privacy Counsel is also responsible for supporting the drafting and negotiation of data privacy terms in FMI’s corporate and commercial agreements. This role works cross-functionally across our legal, compliance, clinical, biopharma, information security, marketing, and business teams.

Key Responsibilities

• Serve as a privacy subject matter expert to FMI for all privacy-related matters, with only limited need for consultation with outside counsel.
• Maintain current knowledge of applicable privacy laws in the US (state and federal) and ex-US (e.g., European Union and foreign national laws), including in the areas of health information privacy, consumer privacy, genetic testing, DNA analysis, and human subjects research.
• Advise FMI on matters related to informed consent, HIPAA authorization, and research protocols.
• Advise FMI on de-identification, pseudonymization, and anonymization standards and requirements. 
• Support investigation, analysis, remediation, and notification of privacy and security incidents.
• Support legal colleagues in drafting, reviewing, and negotiating data use and data protection terms in commercial agreements, vendor agreements, data sharing agreements (e.g., BAAs, DPAs, DUAs), research agreements, clinical trial agreements, and other collaboration agreements.
• Work in strong partnership and collaboration with other members of the privacy team, and the broader legal and compliance department, to continually advance and maintain an effective and dynamic privacy program, including assisting with the development of policies and procedures, privacy training, and awareness activities.
• Participate in certain internal FMI committees as a standing team member.
• Prepare materials and make presentations, as necessary or requested. 
• Independently triage workflow, set clear priorities and expectations with stakeholders, and efficiently deliver results.
• Manage and coordinate with outside privacy counsel, as needed on a case-by-case basis.
• Other duties as assigned.

Qualifications

Basic Qualifications

• Juris Doctor (JD) degree from an accredited law school
• Admission in good standing to any state bar in the United States
• 8+ years of demonstrated experience working in data privacy with at least 5 years of experience working in data privacy within the healthcare sector.

Preferred Qualifications

• 3+ years of direct privacy experience at a healthcare company or institution (e.g., diagnostics, medical device, pharma/biotech, hospital system, healthcare provider)
• Experience advising business and legal colleagues on data privacy laws, regulatory guidance, and industry guidelines, including but not limited to HIPAA, GDPR, the Federal Trade Commission (FTC) Act, CCPA and other state privacy laws, and genetic information privacy laws
• Experience working in privacy program at a HIPAA Covered Entity or advising HIPAA Covered Entity clients on privacy matters
• Experience working in a privacy program of a Controller that complied with GDPR or advising clients on GDPR compliance matters
• CIPP/US or CIPP/E certification
• Ability to apply a risk-based analysis to privacy issues and demonstrate creativity and flexibility in developing solutions that satisfy both business requirements and legal obligations
• Demonstrated ability to prioritize numerous requests for assistance and offer superior advice in a timely, thoughtful, and complete manner
• Ability to:
  • establish and maintain strong relationships within FMI’s business and legal teams;
  • engage professionally with colleagues at all levels, including external partners, and to influence outcomes through effective leadership skills; and
  • work in a dynamic, evolving, and fast-paced work environment, with the confidence and abilities to work independently
• Strong analytical skills and attention to detail
• Excellent collaboration and influencing skills
• Superior judgment and rigor in relation to problem-solving and appropriate escalation of issues
• Excellent written and oral communication and presentation skills
• High level of integrity and trust
• Commitment to FMI values: patients, innovation, collaboration, and passion.

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