Senior Managing Counsel, Health and Life Sciences Americas

Oracle Senior Managing Counsel, Health and Life Sciences Americas Boston, MA Apply Job Description About the role At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global organizations that engage deeply in this space requires a legal/business leader who is deeply steeped in the levers, both public and private that impact this industry. To remain competitive in this rapidly changing landscape, organizations require a legal/business leader who can navigate complex and fast-changing laws, regulations, and public policies across the globe. In this context, we are looking for a legal expert in the life sciences, medical device, and healthcare regulatory space, who will be leading decisions and actions that concern a broad array of risks and opportunities. With his/her regulatory expertise and business acumen, he/she will play a pivotal role in driving Oracle's success and competitiveness in the healthcare and life sciences sector. About the business Oracle's Healthcare and Life Sciences business provides industry-specific software and solutions to healthcare providers, payers, pharmaceutical, and medical device companies, and clinical research organizations. It offers a range of products and services, including cloud-based healthcare platforms, data analytics, electronic health records (EHR), and patient engagement systems. The business aims to help organizations improve patient outcomes, lower costs, and accelerate innovation. By leveraging Oracle's technology and expertise, healthcare and life science organizations can streamline their operations, gain insights from data, and make more informed decisions. Oracle also enables secure and compliant handling of sensitive healthcare data, helping organizations meet regulatory requirements and protect patient privacy. With a focus on digital transformation, Oracle's Healthcare and Life Sciences business empowers the industry to embrace modern technologies and improve overall healthcare delivery. Responsibilities What you'll do As Senior Managing Counsel, Health and Life Sciences Americas, you will oversee Oracle's health and life sciences regulatory legal strategy in North America and Latin American regions, working closely with the life sciences, health and medical device regulatory teams and the Health and Life Sciences Chief Health Compliance Officer and compliance teams, along with product, sales, and consulting teams to develop and implement regulatory and legal strategies to address risks related to healthcare tech and life sciences products, emphasizing patient safety as a priority. You will regularly report to Oracle leadership on health and life sciences regulatory legal risks, work to mitigate risks appropriately, and escalate key risks to senior leadership for action. Additionally, you will work with product, sales, and consulting teams to understand business strategy.

Specific Responsibilities include:

• Lead counsel on legal regulatory issues impacting our customers' use of Oracle products with a focus on electronic health records technologies, artificial intelligence and machine learning, software as a medical device, life sciences clinical research, real world data, AI, and other evolving regulatory areas.
• Advise on the regulatory implications of commercial transactions to enable the fast and efficient completion of commercial transactions in a manner that is viewed positively by our customers and partners.
• Work with the health and life sciences regulatory affairs team to monitor, assess, and advise on relevant regulatory developments and their impact on Oracle Health and Life Sciences products and services.
• Participate in and represent Oracle with various regulatory bodies and agencies and with relevant trade associations.
• Advise on software as a medical device laws and regulations in jurisdictions in the region.
• Formulate strategies to implement patient safety priorities with product teams, leadership, customers, and regulatory authorities as appropriate and promote a patient safety culture.
• Advise on evolving AI/ML regulations relevant to health and life sciences industries and participate in and comment on various public policy initiatives relating to AI/ML.
• Advise on regulatory requirements impacting clinical research, pharmacovigilance, medical product commercialization, fraud and abuse laws, and other relevant legal regulatory requirements, as well as other legal developments relevant to the health and life sciences business lines.
• Input into policy initiatives in the health and life sciences regulatory space.
• Collaborate cross-functionally with other teams, including internal product development, cloud operations, compliance, security, business practices, marketing, and sales teams, to help progress the regulatory program goals and initiatives.
• Maintain high credibility, independence, integrity, confidentiality, and trust. What you'll bring
• We are seeking a J.D. (or a Regulatory Attorney) with +15 years of legal experience in healthcare or life sciences. Minimum qualifications include an advanced degree with 10+ years of relevant work experience in healthcare or life sciences regulatory work.
• Knowledge of healthcare tech and life sciences regulatory requirements in the US is required. Knowledge of Canadian health and life sciences law in addition to the US is preferred.
• Strong domain in Antikickback Statute, False Claims Act, and/or Medical Devices / Medical Devices Software Regulation.
• Professional demeanor, confidence, and innovation with the ability to effectively communicate with senior executives and clients.
• Excellent writing, analysis, negotiation, and partnership skills.
• Problem solver (not just an issue spotter) with a creative, innovative approach and strong decision-making abilities.
• Outstanding project management and interpersonal skills.
• Exceptional business orientation and ability to balance legal considerations with commercial priorities.
• Ability to perform in a fast-paced and continually evolving business environment.

Disclaimer:

Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates. Oracle uses Artificial Intelligence in our recruiting process. Read more about it in our Recruiting Privacy Policy (https://www.oracle.com/legal/privacy/recruiting-privacy-policy/) . Range and benefit information provided in this posting are specific to the stated locations only

CA:

Hiring Range in CAD from: $136,900 to $224,900 per annum.

US:

Hiring Range in USD from: $139,400 to $291,800 per annum. May be eligible for bonus, equity, and compensation deferral. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: Medical, dental, and vision insurance, including expert medical opinion Short term disability and long term disability Life insurance and AD&D Supplemental life insurance (Employee/Spouse/Child) Health care and dependent care Flexible Spending Accounts Pre-tax commuter and parking benefits 401(k) Savings and Investment Plan with company match Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 11 paid holidays Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. Paid parental leave Adoption assistance Employee Stock Purchase Plan Financial planning and group legal Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC5 Vacancy Type - New Position About Us Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life-saving care. And with AI embedded across our products and services, we help customers turn that promise into a better future for all. Discover your potential at a company leading the way in AI and cloud solutions that impact billions of lives. True innovation starts when everyone is empowered to contribute. That's why we're committed to growing a workforce that promotes opportunities for all with competitive benefits that support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_mb@oracle.com or by calling 1-888-404-2494 in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law. Active Filters Senior Managing Counsel, Health ... Boston, MA Clear All Apply