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Director, Privacy Counsel

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Privacy Counsel is responsible for advising Foundation Medicine (FMI) 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) in the United States, under which FMI is a Covered Entity, the General Data Protection Regulation (GDPR) in the European Union, and US state laws like the California Consumer Privacy Act (CCPA).

Key Responsibilities

  • 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 consumer privacy, genetic testing, DNA analysis, human subjects research, health information exchanges, and medical privacy).
  • Demonstrate expertise in HIPAA, state laws, GDPR, HHS Common Rule, and FDA policies for protection of human subjects, with only limited need for consultation with outside counsel.
  • Advise FMI on matters related to informed consent, HIPAA authorization, and research protocols, including obtaining any appropriate waivers or exemptions.
  • Advise FMI on de-identification and anonymization standards and requirements, including expert determinations under HIPAA.
  • Assist Legal colleagues in connection with need for or negotiation of Business Associate Agreements.
  • Along with Privacy Officer, serve as a privacy subject matter expert to FMI for all privacy-related issues.
  • In collaboration with Privacy Officer and the EU Data Protection Officer (as applicable), advise on required breach determination and notification processes under HIPAA, GDPR, and applicable US state breach laws and requirements.
  • Create internal Legal and Compliance guidelines and tools for common privacy topics.
  • Work in strong partnership and collaboration with other members of the Legal and Compliance department to develop, implement, and share best practices, leverage learnings, and create an effective privacy program within the larger Roche enterprise.
  • Participate in certain internal FMI committees as a standing team member.
  • Prepare materials and make presentations to FMI senior leadership, Compliance Committee, and board members, as requested.
  • 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 and membership in at least one state bar
  • 8+ years of demonstrated experience working in data privacy

Preferred Qualifications

  • 3+ years of direct privacy experience in a healthcare company or institution (Diagnostics, Medical Device, Pharma/Biotech, hospital system)
  • 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/privacy matters
  • CIPP/US or CIPP/E certification
  • Demonstrated ability to establish and maintain open and trusting work relationships
  • Demonstrated ability to work efficiently and independently, prioritize workflow, meet demanding deadlines, and manage multi-faceted projects in a fast-moving environment
  • Demonstrated 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
  • Knowledge and understanding of the importance of global privacy laws including, but not limited to, HIPAA, GDPR, and CCPA, and particularly the importance of the obligations of a covered entity to safeguard personal health information
  • Demonstrated organization, facilitation, written and oral communication, and presentation skills
  • Strong analytical skills
  • Excellent collaboration and influencing skills
  • High level of integrity and trust
  • Strong attention to detail, with a pragmatic, practical, decisive, and direct approach
  • Superior judgment and rigor in relation to problem-solving and appropriate escalation of issues
  • Commitment to FMI values: patients, innovation, collaboration, and passion

#LI-hybrid

 

Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

 

About Foundation Medicine

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

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