Description:

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at An American Pharmaceutical Company is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

An American Pharmaceutical Company Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Summary:
This is a unique and exciting opportunity to support BMS's Digital Health Team on new and innovative initiatives and solutions to better service patients. In this role, you will lead the legal support, including directly advising, educating BMS colleagues, staying current on evolving global regulatory, legal and policy environment for BMS' work with digital solutions, including regulated patient and physician-facing digital health solutions (e.g., digital medicine and digital therapeutics) such as mobile applications, diagnostic algorithms, digital biomarkers, use of artificial intelligence and clinical decision support solutions. These digital solutions span across the BMS value chain from clinical trials to manufacturing, to commercialization and market access.

This is a key role within the Law Department's Regulatory Law group and the individual must be able to advise a multi-dimensional client group consisting of commercialization, development, IT, and other enabling functions, as well as liaise across the Law Department with other subject matter experts.

Expertise in Digital Health: The individual will be required to gain and maintain expertise in the rapidly evolving and complex framework of global laws and regulations that impact the development of digital health solutions, including:

Anti-kickback statute/Anti-bribery and Corruption
Product liability
Advertising and promotion of healthcare technology
Consumer data and protection issues (including experience with FTC issues on data usage and consumer data)
Health information privacy and security (HIPAA/GDPR) compliance
Market access and reimbursement (Medicare/Medicaid)
Specific experience in telehealth and structuring compliant provider arrangements.
Medical Device regulations (including software as a medical device)
Artificial intelligence laws, regulations, and guidelines

Development of Policies, Practices, and Companywide Learning: The individual will be required to support internal and external policy and advocacy initiatives advancing laws and regulations in this space, including the development of policies and procedures within BMS in conjunction with the BMS Compliance & Ethics group.

The individual will also be responsible for leading the development of learning materials for business colleagues relating to the appropriate use and creation of digital health tools.

Practical, Solution-Oriented Counseling: The role will provide legal advice on quick moving projects allowing teams to apply appropriate real-time guidance across the enterprise to advance BMS's digital work.

Law Department Collaboration and Education: The role will need to collaborate closely with relevant subject matter experts across the Law Department and Compliance & Ethics to ensure functional understanding of key areas identified above and to gain advice from those experts where additional advice from a particular Law Department expert is required.

This role will also be responsible for education and training across the law department on topics related to digital health to equip therapeutic area, deal, contract, and market lawyers to identify digital health related issues and pull in the Digital Health Legal attorney for additional support.

Qualifications:

Experience and familiarity with privacy laws and regulations is a plus but is not required.
A law degree from a US Law School
7-10+ Years of experience working on digital (preferred), commercial, regulatory and/or R&D issues for pharmaceutical, life sciences, medical devices and/or technology companies, preferably with a law firm that advises companies in highly regulated industries or in-house at a pharmaceutical or biotech or medical device company
Excellent judgement, time management, communication, and cross functional collaboration skills required.
Experience working on digital health initiatives.
Experience and familiarity with privacy laws and regulations is a plus but is not required.