• Medical Director will complete assigned medication utilization reviews (PA) and/or medical necessity appeals for commercial clients; governmental (Medicare/Medicaid) programs and individual client requested coverage determinations or appeals when appropriate • Makes clinical determinations in accordance with medical necessity and criteria • Performs scientific literature evaluation using primary, secondary, and tertiary drug resources to support decision-making and recommendations to requesting prescribers • Follow all internal procedures, job aids, and HIPPA guidelines to protect patient privacy and data security • Support the Department’s responsibilities to provide peer-to-peer phone call support to physicians/prescribers who call the company with specific and general questions about our clinical programs, communications and utilization review decisions • Communicates effectively and confidently with members to promote positive health outcomes • Actively participates in the development of utilization management (PA) criteria and clinical policy revisions/reviews • Ability to work in a fast-paced environment with shifting priorities • Weekend on-call responsibilities (shared rotating call) • Attention to detail and commitment to delivering high-quality work

• Responsible for medical oversight of safety vendor(s) to ensure effectiveness, quality, and compliance of all outsourced activities, support timely triage and narratives for timely case reporting to agencies and for periodic safety reports (e.g., DSURs, PADERs, etc.) in collaboration with other cross-functional teams. • Provide day-to-day medical support for the Safety Operations team and provide updates to internal and external stakeholders, as required. • Reviews incoming adverse event reports to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports. • Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices. • Support safety inspection readiness activities in collaboration with department leadership. • Support the requirements of Safety Data Exchange Agreements with Celcuity partners and ensure compliance with the agreed upon terms and timelines. • Reviews and provides input on the safety sections of clinical documents, including but not limited to the safety reporting section of protocols, Investigator Brochures, and Informed Consents. • Support the development of internal and external (with vendors) key performance indicators and metrics to track performance. • Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB) • Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed • Serves as the Safety subject matter expert for internal audits and global inspections. • Other Duties as assigned.

• Assist the Chief Medical Director to direct and coordinate the medical management, quality improvement and credentialing functions for the business unit • Provides medical leadership of all for utilization management, cost containment, and medical quality improvement activities • Performs medical review activities pertaining to utilization review, quality assurance, and medical review of complex, controversial, or experimental medical services • Supports effective implementation of performance improvement initiatives for capitated providers • Assists Chief Medical Director in planning and establishing goals and policies to improve quality and cost-effectiveness of care and service for members • Conduct regular rounds to assess and coordinate care for high-risk patients • Collaborates effectively with clinical teams, network providers, appeals team, medical and pharmacy consultants for reviewing complex cases and medical necessity appeals • Participates in provider network development and new market expansion as appropriate. • Reviews claims involving complex, controversial, or unusual or new services in order to determine medical necessity and appropriate payment.

Role Description At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry. To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing laws, regulations, and public policies across the globe. In this context, we are looking for regulatory affairs experts in the med-tech space to play a key role in driving Oracle's success and competitiveness in the healthcare and life sciences sector. - Work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device). - Help prepare the required documentation to register products in global markets where the products are sold. - Establish strong partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch to post-market activities of software products in scope. - Define the regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance (e.g. advertising / promotion, etc.), as applicable. - Work primarily with the Oracle Health & Life Sciences business units but will also interact with all Oracle business units selling products to the health and life sciences industries. - Seek a regulatory strategist who is collaborative, a creative problem solver, and dedicated to excellence in their work. Position is opened at the principal level, for 10+ years of experience. One level lower (senior) and one level higher (lead) will also be considered. Qualifications - BA/BS or advanced degree preferred. - Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. - Experience authoring submissions (510k, EU Tech Files, etc.) required. - Experience with sustaining and new product development is ideal. - Experience interacting with notified bodies and/or regulators preferred. - RAC, CQE, CPPS, CQA desired. - Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001, or Quality System Regulations. - Understands continual improvement and risk management. - Excellent written and verbal communication skills. - Ability to adjust and adapt to changing priorities in a dynamic environment. - Ability to perform in a fast-paced and continually evolving business environment. Benefits - Competitive benefits that support our people with flexible medical, life insurance, and retirement options. - Encouragement for employees to give back to their communities through volunteer programs. Company Description Oracle's Healthcare and Life Sciences business is a global leader in industry-specific software and solutions to healthcare providers, payers, pharmaceutical companies, medical device companies, and clinical research organizations. We offer a range of products and services, including AI/ML solutions, 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.