Alumni Profile: Jean Sposaro M.S.J. '15
Jean Sposaro earned her graduate degree through Seton Hall Law's Division of Online Learning. “I love the classroom,” she said, “but the online aspect of the course actually ended up providing a huge benefit."
Jean Sposaro M.S.J. ’15
Clinical Sciences & Operations Scientific Core Platform Assistant Director, Sanofi R&D
Bridgewater, New Jersey
In early February, Jean Sposaro M.S.J. ‘15, of Sanofi, went to Paris to participate in a European consortium of representatives from a diverse group of global pharmaceutical companies and biotechs. This consortium also includes European regulatory agencies and academia interested in sharing information and developing best practices for improving innovation, scientific research, and bioethics. Collaborations include defining how to maximize big research data for better outcomes in patient care.
Next month, Sposaro will travel to Chicago to participate in another collaborative partnership with a nonprofit organization promoting common compliant best practices across the pharmaceutical industry, with the goal of ensuring enhanced ethical clinical research practices and informed consent standards for clinical research participants. Throughout these collaborations, Sposaro partnered directly with the legal counsel of these international organizations.
“Both unique opportunities were a direct consequence of the knowledge I acquired during my M.S.J. experiences at Seton Hall Law,” she noted.
Sposaro began her career as an echocardiographer at a time when new technological advances in medicine were evolving. She quickly expanded her expertise to become a medical educator, department supervisor, and a clinical researcher. She was a medical device business owner for 25 years, operating throughout the New York /New Jersey metropolitan area, during which she gained experience in clinical research and compliance. In the early 2000’s, she encountered increasing challenges with Medicare insurance reimbursements, changing requirements, and other regulatory issues, which impacted her business strategy, her patients’ access to health care, and the compliant business practices of her physician clients.
“I was given an opportunity to enter the pharmaceutical industry in 2005 and quickly realized that there was a strong need to have a better understanding of the regulatory framework and laws which defined the business operations, clinical development, drug submission/approval process, and effective pharmacovigliance systems," she said. "Understanding the consequences of my professional responsibilities and decisions was very important to me. Therefore, I felt that it was important for me to go back to school and seek a degree that focused on compliance law and regulations in the pharmaceutical industry."
She believed a legal degree would provide a solid foundation and the knowledge base necessary to ensure a greater level of confidence in tackling emerging compliance issues and increasingly complicated regulatory obligations. She applied and was accepted to Seton Hall Law, but the demands of her business, her new role in R&D, and her family, made attending classes in Newark implausible at that time.
Yet her desire to pursue a legal education remained constant. “I needed to stay on top of the continuously evolving legal regulations and conflicting international requirements affecting Research and Development, and felt a Masters in Jurisprudence would serve me well,” she said.
Sanofi recruited Sposaro in 2005, inviting her to join its R&D department. “I came into the global pharmacovigilance and epidemiology group, which is focused on ensuring drug safety and risk mitigation strategies for thousands of products and medical devices,” she said. “Soon I was working as a global safety associate, managing a global team, working with physicians, pharmacists and international research thought leaders.” Her experience underscored for her the need to pursue further education in compliance.
“Gaining increasing levels of professional responsibility, collaborating with higher tiers of industry experts, and becoming involved in the development of contractual agreements with partners and vendors, reinforced my desire to enhance my understanding of the regulatory agencies, legal processes, and framework of the laws that define our business practices,” she explained. “I felt that it was critically important to better understand the impact of U.S. and international law when conducting clinical trials and maintaining business agreements, internationally.”
In 2012, when Seton Hall Law introduced the M.S.J. degree program available through its new Division of Online Learning, Sposaro re-applied to Seton Hall Law. “I love the classroom,” she said, “but the online aspect of the course actually ended up providing a huge benefit. It allows international flexibility and increases the scope and understanding of the impact of diversity on the industry.” The online program provided the freedom to strategize study planning based on her schedule, and accommodated business obligations which often included international travel. She enjoyed the emphasis that online classes place on writing and communication skills; something vital to effectively working in a global environment. “I also found opportunities to interact with my professors face-to-face or directly when possible,” she said. “They were a continuous source of inspiration. Their expertise and guidance fueled my passion to learn.”
The case law review, research objectives, high standards for writing requirements and fundamental approach in the program were immediately useful to Sposaro in her day-to-day work. “Biotechnology and the Law, FDA Regulations and Liability, HIPAA and Clinical Research and the Law core classes were directly related to the projects I was managing and leading at work,” she recalled. “I was able to share some case law with senior management to impress upon them the need to stay on top of the evolving regulations in our due diligence, compliance, and continuous process improvements.”
While in her first year of the M.S.J. degree program, she was given the opportunity to collaborate with Sanofi’s corporate medical and clinical quality group and local country affiliates. She was assigned the role of project leader, responsible for assessing the broad scope of her company’s compliance with standard operating procedures and complex international laws. “By my second year, I was selected to be the liaison to the Science Policy Group, and asked to lead a work stream sponsored by our bioethics committee on informed consent of research participants, establishing guidance for best practices and global quality standards,” she said.
It was Sposaro’s knowledge of HIPAA, in fact, that prompted Sanofi’s Data Privacy Office to invite her to Paris to collaborate on evolving scientific innovative medical initiatives linked to bioethical best practices in research and development. “Within the context of my Science Policy Preceptorship and newly developed role, I assisted in authoring our company policies on compassionate use, human biologic samples management, return of incidental findings and informed consent,” she recounts.
Since enrolling in the M.S.J. program, she was also invited to attend an FDA panel on compassionate use, review and provide comments on the OHRPs Notice of Proposed Rule Making on Human Research Protections, the Common Rule and the FDA’s draft guidance on e-Consent. “Being able to understand the way that laws are written, and interpret their potential impact upon R&D, was hugely dependent upon the experiences and skills gleaned from the M.S.J. program,” she explained.
With the completion of her M.S.J. in 2015, Sposaro continues to make her mark at Sanofi and on the industry. “I have been promoted to Assistant Director in Clinical Quality, completed a preceptorship in Science Policy and I have been provided the opportunity to select high profile projects of personal interest,” she said. She has also become an ad hoc member of the Sanofi bioethics committee, “which is quite an honor.”
“I can't believe I'm already going to be out of the program for a year in May,” she said. “I really miss the engagement of the professors and the engagement of the students. Since graduating, so much has happened that continues to stimulate my professional goals and objectives. Looking towards the future, I want to learn more about how policy influences legislation, explore external engagement opportunities, and continue to ensure compliance in the environment in which I work. My most recent opportunities have brought me full circle in my career, which has always been focused on ethical patient care. For now, I remain focused on ensuring ethically and legally compliant scientific innovation, exploring new ways to provide better health care options for all patients around the world.”