Director, Digital Health Privacy & Compliance Counsel

About Otsuka Precision Health

Founded on Otsuka’s rich history in delivering breakthrough innovations to solve complex problems for patients, Otsuka Precision Health (OPH) is the next step in our evolution.  We are a health technology and services organization on a mission.  And that mission is to get people the right interventions at the right time in their health journey through data and technology, leveraging the power of personal connection and deep, data-driven understanding of the patient condition.  OPH is part of Otsuka Holdings.  

Leverage your expertise to help us change the story on the health experience and how we can do our part to fix some of the fragmentation in care delivery.  The time is now.

What you will do (Job Description)

Let’s transform the health experience, one connection at a time, together. 

The Director, Digital Health Privacy & Compliance Counsel will be responsible for leading the Privacy & Compliance program at OPH. The ideal candidate will have experience advising medical device, digital health, and A.I. clients on the application of healthcare privacy and regulatory laws to their business. The position will report to the OPH Executive Director, Deputy General Counsel.  

This role has significant responsibility for overseeing and implementing best practices for all the company review processes and policies that cover the various business activities requiring privacy, compliance, and regulatory review. This includes collaborating and managing shared service support to achieve consistent and efficient processes to support the evolving OPH organization. The Director will collaborate with other members of OPH Legal on complex matters and matters of first impression, as well as provide hands-on and specific guidance both inside and outside the department. All members of OPH Legal and Compliance must exemplify collaborative culture and drive joint accountabilities across multiple stakeholders. As a Director within the Legal team, it is expected the individual will also work independently, be able to develop well-reasoned positions, and know when to appropriately escalate complex and unique topics for further discussion and consideration.

Responsibilities for this role include, but are not limited to: 
•    Assist in developing, implementing, and maintaining a comprehensive healthcare Privacy & Compliance program for OPH 
•    Oversee the development and dissemination of relevant privacy and compliance Policies, SOPs, and Training to OPH employees 
•    Serve as the subject matter expert on international, federal, and state data privacy and security laws and regulations, including GDPR, HIPAA, CCPA, and other such requirements 
•    Provide clear and practical guidance on relevant federal and state laws and regulations, including, but not limited to, the FDCA, FCA, AKS, and FTCA 
•    Stay abreast of on emerging legislative, regulatory, and industry privacy trends, proactively educating relevant stakeholders on such trends and ensuring business is prepared to respond 
•    Advise digital health, data, and A.I. teams on patient, consumer, and other privacy laws and regulations applicable to OPH’s core businesses  
•    Partner with relevant stakeholders to manage regulatory inquiries, government investigations, administrative actions, and internal investigations 
•    Manage periodic privacy and compliance risk assessments, internal audits, and ongoing monitoring 
•    Manage the process for DPIAs, Third-Party Due Diligence, and other privacy and compliance assessments 
•    Draft and negotiate data licenses, data use agreements, and other relevant agreements, as well as advise on technical implementation and compliance with privacy and data security terms 
•    Help optimize priority processes, including Incident Response, Data Subject Request Management, etc. 
•    Manage OPH’s incident management system (Speak-up line) 
•    Coordinate with Global and Regional Otsuka Group Companies Privacy Leads to identify opportunities to drive enhancements across the businesses  

This role can be remote or based in either the Princeton, NJ or Rockville, MD offices. Availability during U.S. Eastern time zone business hours is mandatory. Up to 25% of travel is required based upon business needs regardless of where the role is located. 

What we expect from you
Required Qualifications

•    J.D. admitted to the bar in good standing 
•    7+ years of counseling and advising medical device and healthcare clients on compliance with healthcare privacy and regulatory laws 
•    Experience in the MedTech or Digital Health industry or at a law firm serving such clients, with the ability to bring a foundational understanding of the industry and other related functional areas
•    Experience im