Work From Home Work From Home Work From Home, Indiana 46544 The Supervisor Utilization Management is responsible for the direct supervision of the daily operations of the Centralized Utilization Management department in order to assure that utilization management needs are addressed. This position ensures appropriate staffing levels, ongoing educational opportunities, and employee satisfaction to maintain operational commitment. The Supervisor maintains and enhances relationships with internal and external customers and peers across the continuum in order to facilitate excellent outcomes for patients and Franciscan. WHO WE ARE With 12 ministries and access points across Indiana and Illinois, Franciscan Health is one of the largest Catholic health care systems in the Midwest. Franciscan Health takes pride in hiring coworkers that provide compassionate, comprehensive care for our patients and the communities we serve. WHAT YOU CAN EXPECT - Maintain inter- and intra-departmental communications, special projects, programs, policies, and procedures as well as care management services. - Participate and educate team in performance improvement initiatives. Implement processes to satisfaction with those we are privileged to serve. - Coordinate and maintain compliance with HFAP, state and federal agencies pertaining to Utilization/Denial management activities. - Supervise direct reports and manage the performance of individuals through ongoing coaching, feedback, and development to motivate, engage and drive a high performing team. - Make decisions for direct reports in assigned function and performs people management activities, such as, performance evaluations, disciplinary actions, staff planning, and interviews. - Supervise and maintain Utilization Management operations in collaboration with the Manager and Director, including ensuring appropriate utilization and denial management. QUALIFICATIONS - Bachelor's Degree in Nursing required - Active Indiana Registered Nurse (RN) license required - 5 years of Nursing/Patient Care required - 2 years of Utilization or Case Management experience preferred TRAVEL IS REQUIRED: Up to 20% JOB RANGE: INCENTIVE: Not Applicable EQUAL OPPORTUNITY EMPLOYER It is the policy of Franciscan Alliance to provide equal employment to its employees and qualified applicants for employment as otherwise required by an applicable local, state or Federal law. Franciscan Alliance reserves a Right of Conscience objection in the event local, state or Federal ordinances that violate its values and the free exercise of its religious rights. Franciscan Alliance is committed to equal employment opportunity. Franciscan provides eligible employees with comprehensive benefit offerings. Find an overview on the benefit section of our career site, jobs.franciscanhealth.org.

Overview Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. Responsibilities We are seeking a U.S. East Coast (EST) or European Union based Clinical Safety Manager with global pre-market and post-market study expertise in cardiovascular medical devices. This role is pivotal in ensuring timely review, identification and communication of safety signals for drug eluting balloons and contributing to the execution of our clinical investigations in conformity with all applicable requirements and standards. The Clinical Safety Manager will be responsible for review, evaluation, and analysis of safety events and information from ongoing clinical studies, supporting clinical and regulatory activities across several clinical studies. Key Responsibilities - Continuously review and analyze adverse events and safety data from ongoing clinical studies to monitor and identify any emerging safety signals or trends, potential risks, or emerging safety issues associated with the investigational products. - Investigate, manage and process all Serious Adverse Events (SAEs) for assigned clinical research trials - Support safety-related documents/sections in the clinical program development (e.g. CIP, CSR, ICF, IB, etc.) - Review, or prepare and submit, safety reports to regulatory agencies (individual or summary reports), in compliance with applicable country regulatory requirements and guidelines. - Support safety responses to address any regulatory queries or concerns related to safety signals or safety reports - Perform literature surveillance activities, develop and maintain search strategies to ensure comprehensive safety evaluations and identify any new or unexpected safety issues from published medical literature - Lead regular safety review meetings and contribute to discussions on safety data interpretation, safety signal assessment and risk mitigation strategies. - Generate safety narratives for Adverse Event (AE) cases as required - Create Safety Plans as applicable - Develop DSMB and CEC charters - Oversees timelines for adverse event processing, reviews summary safety data at regular intervals and monitors CEC adjudication results. - Monitor and track all safety action items from safety oversight committees (CEC and DSMB) to ensure timely implementation of any risk mitigation strategy - Support data review and presentation development for data monitoring committee meetings - Contribute to the coding of events according to MedDRA or IMDRF standards. - Manage the monitoring and reporting of personal data breaches (PHI), in compliance with applicable regulations (HIPAA, GDPR) - Contribute upon request to safety documentation for marketed devices: clinical data reviews, periodic safety update reports, etc. Strategic Impact Support oversight of safety management for the sponsored clinical studies and commercial devices, with an initial focus on drug-eluting balloon catheters. Key Interactions - Supervisor: Director of Global Clinical Safety - Internal Interactions: This role will interact heavily with clinical teammates across all projects and cross-functionally as needed with QA, R&D, etc. - External Customer Interactions: This role will work with DSMB and CEC members, Clinical trial physicians and research coordinators, contract research organizations, core labs, etc. Qualifications Required Skills - Master’s or PhD in relevant Scientific field, or equivalent - Minimum of 5 years of relevant experience in safety surveillance with global pre-market and post-market clinical trial experience within the cardiovascular medical device industry. - Safety management experience on US IDE trials - Proficiency with MedDRA (or IMDRF) and experience in safety signal detection and risk management. - Experience in safety data analysis, including analyzing trends and patterns in large datasets. - Solid understanding of FDA, ICH, GCP, SAE reporting and other global medical device regulations and safety reporting requirements. - Experience with safety reporting, guidelines, compliance and oversight across US and EU regions Competencies & Skills - Precise, rigorous, detail-oriented with strong work ethic - Excellent communication, writing and listening skills - Demonstrates strong ability to communicate effectively cross functionally - Exhibits ability to multi-task effectively - Demonstrates solid project management skills and strong attention to detail - Self-driven and motivated - Ability to analyze, interpret, and summarize complex data - Strong problem-solving abilities - Fluent in English Pay / Compensation The expected pre-tax pay rate for this position is $114,950 – 165,000 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location. US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Overview Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. Responsibilities Remotely based on the U.S. East Coast or in the EU, the Clinical Safety Specialist monitors all safety aspects of our clinical research trial(s). With guidance, the Clinical Safety Specialist is responsible for collecting, assessing and processing Adverse Events (SAE) for safety reporting, CEC and DSMB across our clinical studies to ensure compliance with regulations and guidelines. Key Responsibilities - Execution of Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB): - Adheres to the study protocols and charters. - Provides reports and statistics related to dissemination of safety information to the clinical trial management team members and clinical trial core team members, as appropriate. - Monitors timelines for adverse event processing, reviews summary safety data at regular intervals and monitors CEC adjudication results. - Initiate missing data queries/data clarification queries to clinical sites regarding adverse events. - Requests appropriate source documentation necessary to analyze adverse events for seriousness and causality. - Prepares narratives of adverse events for adjudication by the CEC. - Participates in the preparation, attendance and hosting of CEC and DSMB meetings, providing agenda, recording/reviewing and distributing of minutes to key stakeholders internally and externally including CEC/DSMB Chair - Collects, reviews and files all clinical study documentation/correspondence and maintains the clinical trial master file (TMF). - Synthesizes information from various sources as it pertains to the safety of all patients enrolled in a study in accordance with study protocols and compliance with governmental/health authority regulations. Safety Surveillance and Reporting - Assists with reporting adverse events (individual or summary reports), and any other activity in keeping with the defined endpoints of the trial charters. - Reviews adverse events reported in clinical study for the identification and evaluation of safety issues and any patterns that are identifiable. - Collaborate with Data Management and contribute to the cleaning of data. - Reports safety findings in a summary internally. - Contribute to the coding of events according to MedDRA or IMDRF standards. - Interfaces with project management, functional team members and investigators to ensure a timely and precise safety reporting process. - Assists in preparing clinical study reports of assigned projects for submission to regulatory authorities. Personal Health Information / GDPR compliance - Contribute to the monitoring and reporting of personal data breaches that may be identified in the course of clinical investigations (e.g. source documentation). Strategic Impact - Supports clinical safety management for all sponsored clinical studies, with an initial focus on drug-eluting balloon catheters. Key Interactions - Supervisor: Director of Global Clinical Safety - Internal Interactions: This role will interact heavily with clinical teammates across projects - External Customer Interactions: This role will be working with DSMB and CEC members, Clinical trial physicians and research coordinators, contract research organizations, core labs, etc. Qualifications Required Experience - Bachelor’s degree - Minimum of 3 years of experience in medical device clinical studies - Experience with safety reporting, guidelines, compliance and oversight across US and EU regions, pre-market and post-market - Cardiovascular experience Competencies & Skills - Precise, rigorous, detail-oriented with strong work ethic - Excellent communication, writing and listening skills - Fluent in English - Professionalism and ability to effectively interact with peers and management alike - Ability to verbally communicate effectively with management, department clinical research and other team members Pay / Compensation The expected pre-tax pay rate for this position is $78,650 – 105,600 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location. US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Physician Advisor (Utilization Review) Part-Time | Remote (U.S. Based) Medical Review Institute of America (MRIoA) is a nationally recognized leader in utilization management and clinical review services, delivering evidence-based solutions for more than 43 years. We are currently seeking a part-time Physician Advisor to join our growing, fully remote team. POSITION OVERVIEW In this role, you will apply your clinical expertise to evaluate requests for medical services, interpret benefit language and medical policies, and make sound coverage determinations. You may also engage in peer-to-peer discussions with treating providers. This position emphasizes independent clinical judgment, thorough documentation, and collaboration with a nationwide team of Medical Directors. Core Responsibilities - Perform clinical coverage reviews using member benefits, medical policies, and established clinical guidelines - Interpret benefit language to support accurate and compliant determinations - Document review outcomes in alignment with regulatory, accreditation, and internal standards - Participate in peer-to-peer discussions with treating providers as needed - Collaboration with Medical Directors across multiple specialties and regions Work Schedule - 10-30 hour per week requirement - Flexible (but prescheduled) shifts between the hours of 6:00 a.m. - 7:00 p.m. MST (8:00 a.m. – 9:00 p.m. EST). Strong preference for shifts to be scheduled in 4-hour blocks. (6a-10a, 10a-2p, 2p-6p or 3p-7p Mtn time). - Must commit to 2 weekend shifts per month (4 hour shifts minimum) - Schedules are determined by physician and fixed 2 months in advance - Dedication during scheduled hours is required Requirements  To be eligible for this position, candidates must meet the following criteria: - Hold an active, unencumbered state licensure as a Medical Doctor (MD/DO), any state. - Hold current board certification in either Family Medicine or Internal Medicine (no other board-certified specialty is currently needed). - Possess a minimum of 5 years of direct patient care experience. - High level of computer proficiency and comfort with multiple software programs - Ability to be fully dedicated during scheduled work hours (Caregiving or other responsibilities during work hours are not permitted) - Must reside and work within the United States Additionally: - This is a part-time (W2), non-benefited role - Malpractice insurance is not required, as physicians do not provide direct patient care. Reviewers are covered under MRIoA's Errors and Omissions policy. Equipment Requirements - All necessary computer equipment is provided. - For security, computers must be hard-wired via Ethernet (Wi-Fi is not permitted). Work Environment: Ability to sit at a desk, utilize a computer, telephone, and other basic office equipment is required. This role is designed to be a remote position (work-from-home). Diversity Statement: Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law. Drug-Free Workplace: This company is a drug-free workplace. All candidates are required to pass a Background Screen before beginning employment. All newly hired employees will take a Drug Screen, as well as agreeing to all necessary Compliance Regulations on their first day of employment. Employees are required to adhere to all applicable HIPAA regulations and company policies and procedures regarding the confidentiality, privacy, and security of sensitive health information. California Consumer Privacy Act (CCPA) Information (California Residents Only): - Sensitive Personal Info: MRIoA may collect sensitive personal info such as real name, nickname or alias, postal address, telephone number, email address, Social Security number, signature, online identifier, Internet Protocol address, driver’s license number, or state identification card number, and passport number. - Data Access and Correction: Applicants can access their data and request corrections. For questions and/or requests to edit, delete, or correct data, please email the Medical Review Institute at HR@mrioa.com.