Director, Digital Health Corporate Counsel

Otsuka Pharmaceutical Co.; United States; Remote; USD 183,000 - 275,000; Full time

Job summary

Join a forward-thinking health technology organization as a Director of Digital Health Corporate Counsel. This exciting role involves providing legal guidance to digital health and data teams, ensuring compliance with healthcare regulations while fostering collaboration across departments. You will play a pivotal role in shaping the future of healthcare delivery by advising on regulatory matters and supporting product development. With a commitment to innovation and personal connection, this position offers the chance to make a significant impact in the health technology space. Embrace the opportunity to work in a dynamic environment where your expertise will drive meaningful change.

Benefits

Comprehensive employee benefits package

401(k) match

Flexible work models

Discretionary annual bonus program

Tuition reimbursement

Student loan assistance

Flexible time off

Paid holidays

Paid leave programs

Qualifications

• 7+ years of experience in legal counseling for medical device and healthcare clients.
• Strong understanding of healthcare regulations and compliance.

Responsibilities

• Provide legal counsel on corporate and regulatory matters for digital health products.
• Review and negotiate contracts and manage compliance risks.

Skills

Healthcare Regulatory Laws

Legal Counseling

Communication Skills

Problem-Solving Skills

Analytical Skills

Leadership Skills

Education

J.D. Degree

Job description

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 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)

The Director, Digital Health Corporate Counsel will be responsible for providing legal counsel to digital health and data teams at OPH. The ideal candidate will have experience advising medical device, digital health, and A.I. clients on the application of healthcare regulatory laws to their business. The position will report to the Executive Director, Deputy General Counsel.

The Director will collaborate with other members of the OPH Legal team 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:

• Support product, commercial, and operational teams developing OPH products, services, and technology on a broad array of corporate and regulatory matters.
• Provide strategic advice, legal direction, and training on applicable laws and regulations related to the development and commercialization of OPH healthcare products, services, and technology. Expert knowledge of medical device and consumer protection (e.g., FDA, FTC), healthcare compliance (e.g., FCA, AKS), and privacy (e.g., GDPR, HIPAA, CRPA) regulations.
• Maintain awareness of emerging laws, regulations, and guidance applicable to OPH's core businesses. Provide regular updates to key stakeholders as relevant regulatory authorities update guidance and as enforcement activities develop.
• Review and negotiate a variety of contracts, including vendor, regulatory service, and SaaS agreements, and BAAs.
• Identify opportunities for developing policies, tools, templates, playbooks, and processes to scale legal operations.
• Partner with Privacy, Security, and Compliance teams to efficiently manage risks across OPH.
• Perform other work-related duties as assigned.

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 healthcare 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.
• Excellent communication and collaboration skills, with the ability to develop strong relationships and influence stakeholders across the organization.
• Demonstrated leadership experience.
• Strong problem-solving skills, with an ability to creatively identify and implement solutions.
• Excellent analytical skills and the ability to appropriately communicate complex compliance and legal concepts and their relevant potential risks clearly to non-legal stakeholders for consideration.
• Ability to travel up to 25%.

Preferred Qualifications

• Legal and/or compliance experience in a digital health, tech, and/or AI company.

What you can expect of us

As we work to develop solutions that enhance peoples' lives, we also work to care for our teammates' professional and personal growth and well-being. This role is intended to be remote with intentional travel as described in the qualifications section.

In addition to the base salary, OPH offers a benefits program comprising health and wellness plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program.
• Flexible work models, including remote work arrangements, where possible.

Competencies

• Accountability for Results: Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving: Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity: Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication: Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration: Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development: Play an active role in professional development as a business imperative.

Salary Range: Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity. The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.