Join the Texas Health and Human Services Commission (HHSC) and be part of a team committed to creating a positive impact in the lives of fellow Texans. At HHSC, your contributions matter, and we support you at each stage of your life and work journey. Our comprehensive benefits package includes 100% paid employee health insurance for full-time eligible employees, a defined benefit pension plan, generous time off benefits, numerous opportunities for career advancement and more. Explore more details on the Benefits of Working at HHS webpage. Functional Title: Program Compliance Coordinator Job Title: Program Specialist VI Agency: Health & Human Services Comm Department: Settlement Agreement Complianc Posting Number: 15209 Closing Date: 04/06/2026 Posting Audience: Internal and External Occupational Category: Personal Care and Services Salary Range: $5,098.66 - $8,304.83 Pay Frequency: Monthly Salary Group: TEXAS-B-23 Shift: Day Additional Shift: Telework: Eligible for Telework Travel: Up to 35% Regular/Temporary: Regular Full Time/Part Time: Full time FLSA Exempt/Non-Exempt: Exempt Facility Location: Job Location City: AUSTIN Job Location Address: 909 W 45TH ST #634 BLDG 4 Other Locations: MOS Codes: 16GX,60C0,611X,612X,63G0,641X,712X,86M0,8U000,OS,OSS,PERS,YN,YNS Brief Job Description: Come work in an environment where we truly value and respect those we serve and believe in the mission that all people can achieve a higher level of wellness and independence. The state supported living centers serve people with intellectual and developmental disabilities who are medically fragile or who have behavioral problems. The centers provide campus-based direct services and supports at 13 centers located throughout the state. Learn About Our State Supported Living Centers If you are looking for a place to work where you can establish a career that is filled with purpose, this is the job for you! The Program Compliance Coordinator (PCC) reports to the Quality Assurance Manager and is a member of the Quality Improvement team at the State Supported Living Center (SSLC) State Office. This position can be based anywhere in Texas and must routinely report to their headquarters location. This position requires significant travel to SSLCs (35% of work schedule). The PCC is assigned to 6 or 7 SSLCs and serves as a Quality Assurance subject matter expert. Performs highly advanced (senior-level) consultative services and technical assistance work in the areas of quality assurance and improvement. The PCC works closely with the SSLC State Office team and SSLC staff to monitor and report progress towards compliance with Intermediate Care Facility for Individuals with Intellectual Disability (ICF-IID) Conditions of Participation and quality assurance and quality improvement (QA/QI) processes and initiatives. As part of the QA and QI oversight process, conducts remote and on-site review of documents, on-site observations and interviews, and prepares narrative reports. Assists with the development of improvement plans and other QA/QI activities as needed. Tracks recommendations when plans of improvement are initiated to assist Centers with action step implementation and ensure recommendations are completed and have supporting evidence. Provides updates on SSLC progress in response to findings and action plans. Travels to assigned SSLCs to monitor and provide technical assistance to Center staff on minimum requirements and best practices. Works under minimal supervision, with considerable latitude for the use of initiative and independent judgment. Essential Job Functions (EJFs): Attends work on a regular basis and may be required to work a specific shift schedule or, at times, even a rotating schedule, extended shift and/or overtime in accordance with agency leave policy and performs other duties as assigned. May serve in an on-call status on a rotating schedule as required to meet operational needs of the SSLCs. Extensive travel (35%) is required. For assigned SSLCs, provides technical support, on-site or virtually, during quality assurance-oriented meetings. Meetings include Quality Assurance/Quality Improvement Council (QAQI) meetings, monthly/quarterly department lead meetings, State Office monthly QA meeting with assigned Centers, corrective action plan (CAP) team meetings, and plan of improvement (POI) meetings. Elevates concerns to the Quality Assurance Manager. Conducts at least one on-site visit annually, or more as needed, to provide on-site monitoring, verify/validate the completion of QA action plans and implementation of directives. While on-site, evaluates programs, procedures, and/or processes for effectiveness through the use of designated monitoring tools. Analyzes data and documentation and provides recommendations for improvement or identification of best practices. Participates in internal State Office meetings to discuss findings, observations, provide updates when needed, and with the help of other State Office staff, identify issues requiring SSLC Director notification, and assists in developing actions to address compliance gaps or performance concerns. Provides technical assistance to other State Office staff and the Center, as needed. After each on-site visit, prepares a report of findings within assigned time frames. Provides updates on status to Center administration and State Office both verbally and in writing. Submits the report to the Quality Assurance Manager for approval and distributes to State Office and the Center. Works with the Center after the visit to coordinate action plans and improvements. Addresses comments and questions about findings from Center and/or State Office staff. Makes recommendations to improve QA and QI processes when needed. In between on-site visits, regularly reviews QAQI reports, data inventory, and improvement plans for assigned Centers to provide feedback and work with Center staff to clarify and edit them. Provides oversight and verification of Center QA processes such as submitting required documents, completing quality audits, and conducting data validation. When needed, coordinates the Center, State Office discipline coordinators, and QA staff when progress is not made or concerns are identified. When a plan of improvement (POI) is required for an assigned Center, the PCC compiles the POI by collecting data from QA and action items from subject matter experts and serves as liaison between the Center and State Office throughout the POI process. Conducts on-site observations at a determined interval to verify POI action steps are complete. Attends all POI meetings and communicates concerns to SSLC leadership. Collaborates with other State Office staff to promote facility compliance with Intermediate Care Facility for Individuals with Intellectual Disability (ICF-IID) Conditions of Participation and system-wide policies and procedures. Analyzes the implementation of and variation within processes across SSLCs to develop action plans for improving processes or initiating new ones. Provides consultation and technical assistance on quality assurance and improvement processes to other State Office staff. Other potential collaborative activities include developing program policies, procedures, standards, and manuals, developing and implementing new monitoring tools, identifying the need for new programs, and providing training and guidance to staff in the development and integration of new methods and procedures. As needed, conducts on-site visits to assigned Centers to assist with review or implementation of ad hoc Center initiatives. Duties for ad-hoc visits could include compiling data and preparing a report within assigned time frames after the on-site review. Provides updates on status to Center administration and State Office both verbally and in writing. Works with the Center after the review to coordinate action plans and improvements. Develops recommendations to improve QA/QI processes when needed. Other duties as assigned include but are not limited to actively participating and/or serving in a supporting role to meet the agency’s obligations for disaster response and/or recovery or Continuity of Operations (COOP) activation. Such participation may require an alternate shift pattern assignment and/or location. Knowledge, Skills and Abilities (KSAs): Basic knowledge of local, state, and federal laws and standards related to the program area to include Intermediate Care Facilities/Individuals with Intellectual Disabilities (ICF/IID), Texas Administrative Code (TAC), and HHSC policies and procedures related to State Supported Living Centers, or ability to gain that knowledge. Knowledge of security procedures for handling, protection, and distribution of confidential data. Working knowledge and understanding of electronic health records. Knowledge of statistical analysis processes; and of program planning and implementation. Skill in data validation. Skill in using monitoring tools to evaluate performance. Ability to gather, assemble, correlate, and analyze facts. Ability to devise solutions to problems. Ability to prepare technical reports, to communicate effectively, to train, lead and coordinate the work of others. Ability to collect, interpret, organize, verify, and disseminate significant amounts of information with attention to detail and accuracy. Ability to provide direction and guidance to others Ability to travel extensively (35% of the time) Registrations, Licensure Requirements or Certifications: None Initial Screening Criteria: Bachelor’s degree from an accredited college or university with at least one year of ICF-IID experience OR Associate’s degree with three years of ICF-IID experience. Experience writing reports. Experience conducting on-site monitoring, observations or program assessments. Experience evaluating compliance with administrative and programmatic requirements, policies, and guidelines is preferred. Additional Information: Applicants must pass a fingerprint criminal background check, pre-employment drug screen, and registry checks including the Client Abuse/Neglect Reporting System (CANRS), Nurse Aide, Medication Aide and Employee Misconduct and HHS List of Excluded Individuals/ Entities (LEIE). Males between the ages of 18 – 25 must be registered with the Selective Service. All State Supported Living Center Employees are subject to Random Drug Testing. Flexibility in work hours may be required for this position. The position may be required to work overtime and/or extended hours. Must be willing to work weekends and holidays. All applicants must be at least 18 years of age to be considered for employment at a state-operated facility. Review our Tips for Success when applying for jobs at DFPS, DSHS and HHSC. Active Duty, Military, Reservists, Guardsmen, and Veterans: Military occupation(s) that relate to the initial selection criteria and registration or licensure requirements for this position may include, but not limited to those listed in this posting. All active-duty military, reservists, guardsmen, and veterans are encouraged to apply if qualified to fill this position. For more information please see the Texas State Auditor’s Job Descriptions, Military Crosswalk and Military Crosswalk Guide at Texas State Auditor's Office - Job Descriptions. ADA Accommodations: In compliance with the Americans with Disabilities Act (ADA), HHSC and DSHS agencies will provide reasonable accommodation during the hiring and selection process for qualified individuals with a disability. If you need assistance completing the on-line application, contact the HHS Employee Service Center at 1-888-894-4747. If you are contacted for an interview and need accommodation to participate in the interview process, please notify the person scheduling the interview. Pre-Employment Checks and Work Eligibility: Depending on the program area and position requirements, applicants selected for hire may be required to pass background and other due diligence checks. HHSC uses E-Verify. You must bring your I-9 documentation with you on your first day of work. Download the I-9 Form Telework Disclaimer: This position may be eligible for telework. Please note, all HHS positions are subject to state and agency telework policies in addition to the discretion of the direct supervisor and business needs.

Role Description We’re looking for a motivated and collaborative Senior Manager, Regulatory Affairs, CMC to join our growing team at Delcath. In this role, you’ll have the opportunity to make a meaningful impact while working alongside talented colleagues in a supportive and innovative environment. The Senior Manager, Regulatory Affairs, CMC is responsible for executing the day-to-day tactical activities of CMC regulatory submissions, with specific emphasis on compiling and submitting regulatory submissions. The Senior Manager, Regulatory Affairs shall provide direct regulatory submission support for NDA/IND for our oncologic drug/device combination product that is regulated as a drug. Essential Duties and Responsibilities - Must be familiar with the Quality Systems Registration under 21 CFR 820, Regulation of Combination Products 21 CFR 4, and EU Medical Device Regulation (MDR). - Must have knowledge of Investigational New Drug regulations under 21 CFR 312 and Applications for FDA Approval to Market a New Drug regulations under 21 CFR 314. - Must have device product experience; drug/device combination product experience a plus. - Must be familiar with FDA’s current thinking and guidance for industry. - Execute day-to-day processes for regulatory accountabilities to ensure continual regulatory compliance with FDA and MDR requirements. - Work closely with regulatory team and internal staff to prepare, review and submit international regulatory and domestic submissions, including NDA, IND and CTA supplements and amendments. - Assist in the preparation, review, and submission of annual reports, amendments, and supplemental applications to INDs, NDAs, and CTAs. - Monitor, review, and interpret new or revised regulatory requirements and proactively advise corporate disciplines. - Review and interpret technical and scientific data to ensure regulatory requirements are met; evaluate product/design and process changes for potential effect upon product safety and effectiveness; and appropriately document the regulatory disposition of such changes. - Other activities as assigned by management. Qualifications - A BS or MS degree in physical or life sciences required. - At least 5 years drug regulatory affairs experience in the pharmaceutical industry, with direct accountabilities related to Health Authority submissions and compliance related matters. - Direct working knowledge of FDA and International drug regulations. - Experience working across multi-disciplinary levels, functions, and regions is required. - Team oriented, with the ability to work well with diverse cross-functional teams. - Strong analytical and process skills; computer proficient in EXCEL, MS Project, PowerPoint, Word, etc. - Strong verbal and written communication skills. - Willingness to travel. Requirements - Must be able to read and interpret technical documents. - Must be able to effectively write routine reports and correspondence. - Must possess the ability to speak effectively with employees and outside organizations. - Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. - Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - Regularly required to sit, stand or walk and talk or hear. - Frequently required to use hands to finger, handle, or feel and reach with hands and arms; subject to repetitive motions of the wrists, hands, and/or fingers. - Occasionally lift and/or move up to 10 pounds. - Specific vision abilities required include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Screen reader users may encounter difficulty with this site. For assistance with applying, please contact hr-accessibleapplication@osu.edu. If you have questions while submitting an application, please review these frequently asked questions. Current Employees and Students: If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process. Welcome to The Ohio State University's career site. We invite you to apply to positions of interest. In order to ensure your application is complete, you must complete the following: - Ensure you have all necessary documents available when starting the application process. You can review the additional job description section on postings for documents that may be required. - Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application. Job Title: Lead Regulatory Compliance Officer | CCC - Clinical Trials Office Department: CCC | Clinical Trials Office Position Summary Lead Regulatory Compliance Officer serves as primary resource in regulatory aspects by providing regulatory expertise to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the OSUCCC Clinical Trials Office. Responsibilities - Assists the Regulatory Manager with the daily oversight of the Regulatory team and monitoring of the regulatory research compliance function across all disease teams managed by the Clinical Trials Office (CTO). - Conducts interviews for regulatory staff and trains, mentors, and supervises staff. Serves as the subject matter expert for all regulatory compliance officers within the department by monitoring & ensuring compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state & industry sponsor regulations. - Answers questions and provides technical support to junior members on the team. - Provides coverage/back up as needed for Regulatory manager and/or team members. Serves as lead Regulatory contact for external audits; performs quarterly spot checks of regulatory files. - Participates in the development of SOPs and Processes for the regulatory team to stay current with the changing regulatory requirements and training. Participates in the creation and delivery of onboarding and educational training programs, tools and materials for CTO staff, and investigators. - Provides regulatory guidance, direction and support to all members of research team. - Stays current on legislation, rules, regulations, procedures, and development; educate physicians and staff regarding change as related to clinical research protocols, university staff, affiliates, and patients. - Work with CTO Managers and coordinators as needed to ensure understanding of study protocols. Job Requirements Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required; Master’s degree in a relevant field desired; clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) required. Three to five years of experience in a clinical research or administrative capacity working on clinical research projects required; knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required; experience and knowledge of federal & industry research sponsor requirements preferred; experience in a regulatory affairs capacity in a medical research setting desired; experience in protocol development desired. Additional Information: Research Administration / Research Compliance - Individual Contributor - Specialized - S4 Consultant Location: Remote Location Position Type: Regular Scheduled Hours: 40 Shift: First Shift Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process. Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions. The university is an equal opportunity employer, including veterans and disability.

By joining Sedgwick, you'll be part of something truly meaningful. It’s what our 33,000 colleagues do every day for people around the world who are facing the unexpected. We invite you to grow your career with us, experience our caring culture, and enjoy work-life balance. Here, there’s no limit to what you can achieve. Newsweek Recognizes Sedgwick as America’s Greatest Workplaces National Top Companies Certified as a Great Place to Work® Fortune Best Workplaces in Financial Services & Insurance OSHA Representative | Remote PRIMARY PURPOSE: To provide OSHA services designed to assist and support client OSHA recordkeeping obligations, run QC/exception reports, generate routine and ad hoc reports as requested and facilitate client compliance with regulatory requirements. ESSENTIAL FUNCTIONS and RESPONSIBILITIES - Reviews, identifies, analyzes and evaluates cases for OSHA 1904 recordkeeping requirements. - Maintains current knowledge of and adheres to company internal policies and procedures, corporate directives, standard operating procedures, professional account management standards, and client service standards. - Provides reports, advice, and counseling; generates reports via one OSHA application for OSHA inspectors. - Conducts QC/exception reports as dictated by best practices and/or team lead. - Communicates information to include interpretation of regulations to claims staff and determines time loss from work. - Works with risk services colleagues to help develop prospects into clients. ADDITIONAL FUNCTIONS and RESPONSIBILITIES - Performs other duties as assigned. - Supports the organization's quality program(s). QUALIFICATIONS Education & Licensing High school diploma or GED required. Proficiency in Excel required. Experience Two (2) years of workers compensation services or technically related experience or customer services experience or equivalent combination of education and experience required. Skills & Knowledge - Oral and written communication, including presentation skills - PC literate, including Microsoft Office products - Proficiency in Excel - Analytical and interpretive skills - Good organizational skills - Ability to work in a team environment - Ability to meet or exceed Performance Competencies WORK ENVIRONMENT When applicable and appropriate, consideration will be given to reasonable accommodations. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines Physical: Computer keyboarding, travel as required Auditory/Visual: Hearing, vision and talking As required by law, Sedgwick provides a reasonable range of compensation for roles that may be hired in jurisdictions requiring pay transparency in job postings. Actual compensation is influenced by a wide range of factors including but not limited to skill set, level of experience, and cost of specific location. For the jurisdiction noted in this job posting only, the range of starting pay for this role is $19.00/ hr. A comprehensive benefits package is offered including but not limited to, medical, dental, vision, 401k and matching, PTO, disability and life insurance, employee assistance, flexible spending or health savings account, and other additional voluntary benefits. Always accepting applications. The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Sedgwick is an Equal Opportunity Employer and a Drug-Free Workplace. If you're excited about this role but your experience doesn't align perfectly with every qualification in the job description, consider applying for it anyway! Sedgwick is building a diverse, equitable, and inclusive workplace and recognizes that each person possesses a unique combination of skills, knowledge, and experience. You may be just the right candidate for this or other roles.