• Liaise with SAR colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis • May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc. • Where required provide local QC of submission dossiers prior to dispatch • Effectively communicate to the SAR Lead and relevant project team members the status and action plans concerning submissions • Identify risks and generate mitigation strategies • When possible, foster professional working relationships with internal and external contacts to ensure expeditious submission/approval of regulatory dossiers • Maintain country specific patient information sheet and consent form customization text • Maintain country specific drug labeling information • Maintain Country Intelligence Pages • Be familiar with and comply with SOPs, ICH GCP and applicable regulations • Stay informed of changing regulatory legislative requirements and maintain regulatory intelligence database • Advise the SAR project team about appropriate regulatory strategies • Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements • Provide timely and relevant updates and communication of changes in the regulatory environment to the Regulatory Affairs department • Provide advice to the Regulatory Affairs department on interpretation of new legislation, guidance and directives

• Direct the preparation, implementation, and coordination of regulatory projects for new product introductions and lifecycle maintenance across the U.S. (Federal and State), as well as Canada and Mexico if expertise supports. • Apply expert knowledge of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to register traditional actives, “me-too” products, biopesticides, and antimicrobial/biocide products. • Navigate the unique regulatory landscapes for biologicals, leveraging recent regulatory developments to accelerate time-to-market. • Perform comprehensive data gap analyses, draft waiver requests, and design testing strategies to meet EPA and state-level requirements in partnership with relevant internal technical experts. • Draft and review regulatory labels for compliance with federal and state labeling laws. • Act as a primary point of contact for the knoell team for North America expertise, contributing to education of the team on regulatory pathways, risks, and opportunities while supporting long-term client relationships. • Mentor and provide technical guidance to regulatory specialists and managers. • Provide expertise alongside project managers in initial client inquiry calls, and collaborate on client proposals and quotes, advising on budget needs. • Provide competitive intelligence and insights into emerging regulatory trends.

Role Description The Regulatory Specialist performs a variety of duties, technical and administrative tasks, and customer relations functions in support of city permit, country permit, railroad permit processes along with Corp of Engineers permitting requirements. - Project scheduled to kick off this summer, June-September. Essential Tasks and Responsibilities - Ensures that permits are acquired correctly and promptly. - Communicates directly with the client regarding agreement language, compensation, insurance requirements, bonds, and long lead items. - Collaborates and communicates with other permit agents, survey crew, drill crew, and recording crew to maximize efficiencies. - Participates in the permit project start-up meetings and ensures an absolute understanding of all topics discussed. - Completes all necessary paperwork. - Researches ownership for surface and/or minerals. - Negotiates and acquires necessary surface and/or mineral permits for crew access. - Works directly with the project manager, project engineers, and surveyors to receive the necessary documents such as calculations, pipeline specifications, and exhibits. - Supports surveying, drilling, and recording phases, making sure permit stipulations are followed, and addressing problems as the issues arise. - Other duties as assigned or required. Qualifications - Bachelor's degree or experience equivalent to a four-year degree is preferred. - Minimum of 3 years' relative experience. - Good communication and organizational skills. - Knowledgeable about survey drawings, engineering drawings, and alignment sheets. - Strong communication skills. - Ability to effectively handle multiple tasks. - Ability to work autonomously and to collaborate fully as a team player. - Ability to pay close attention to details, and present good planning, organization, and time management skills. - Ability to work in a team environment and willingness to assume additional or new responsibilities readily. - Ability to maintain regular attendance as per work schedule agreed with the manager (may require working an adjusted work schedule based on project assigned and work overtime if warranted). - Ability to comply with applicable laws and regulations and Company policies and procedures. Work Environment and Physical Demands - Spends a mixture of the time in an office and field environment. - Is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms, and talk or hear. - Is occasionally required to stand, walk, and stoop, kneel, or crouch. - Is occasionally required to lift and/or move up to 25 pounds. - Specific vision abilities include close vision, distance vision, color vision, and the ability to adjust focus.

Role Description Primary responsibility is to independently perform clinical chart reviews, risk adjustment audits, payor audits, coding analysis, charge/reimbursement analysis, medical records reviews, and educate provider personnel on coding methodologies that will result in improved accuracy by following RMG compliance standards for commercial and government payors. This position serves as subject matter expert to coordinate review and root cause analysis of coding follow-up/denial and audit work queues, coding denial volumes, and coding trends. Responsible for identifying and reporting obstacles, patterns, and variations as well as resolutions in a timely, clear and concise manner. Serves as an expert for all coding-related questions and is responsible for providing educational materials to answer questions from clinical/office managers, providers and other administrative personnel. What you will do - Independently conducts Medical Record audits following official coding guidelines and interprets and applies Federal and State regulations, coding and billing requirements for Baseline, Annual, Post Education and Focused provider chart reviews. - Analyzes provider coding and documentation to evaluate risks relating to future payor recovery audits. - Uses expertise and discretion to apply necessary corrections to ensure compliance with payor rules and regulations with appropriate databases. - Demonstrates expertise and ensures that all Third Party Payor reviews are completed timely with all requested supporting documentation (e.g. Medical records). - Researches payor rules (e.g. manuals, policies and other sources) for support and guidance. - Pre-reviews files and materials and provides summary of findings so that issues can be shared with the department director. - Works in alliance with RHS Internal Auditing. - Reports and tracks necessary corrections to ensure compliance with payor rules and regulations with appropriate databases. - Analyzes coding related to: - Ensuring work queues are worked timely and accurately and reporting concerns to department managers, and/or Director. - Identifying trends. - Conducting root cause analysis of trends. - Developing action plans for corrective action. - Makes recommendations to Manager and practices/departments, including Patient Accounting (CBO), Physicians and Contracting to resolve the denied claims and provide education to reduce future denials. - Audits both aggregate coded data and individual encounter data to independently determine opportunities for education, training and documentation improvement for both individual providers and RMG Coding team. - Provides feedback and suggestions to providers/coders regarding coding accuracy. - Identifies trends and opportunities for improvement in clinical documentation and reports this information to the Director. - Works with newly hired team members’ orientation program to ensure understanding of office based payor regulations (ABN, HIPAA, Incident to/shared visits). - Oversees the department’s new team member and reports on evaluation results with any recommendations as needed. - Assists with and/or provides suggestions for continuing education topics and issues for coding staff. - Interacts with and educates coding staff in specialty topics. - Develops and maintains all presentations and tracking logs. - Works collaboratively with both internal and other departments with assistance and guidance. - Answers questions and solves complex coding problems which includes performing preliminary research on topics such as coverage determinations, coding guidelines or standards of care with an emphasis on improving efficiency. Qualifications - High School Diploma or GED (Required) - 3-4 years Commercial and Government Billing/Coding/Collections (Required) - 1 year Medical Record Reviews (Required) - Certified Professional Coder (CPC) - American Academy of Professional Coders (AAPC) (Required) or Certified Outpatient Coder (COC) - American Academy of Professional Coders (AAPC) (Required) - Certified Professional Medical Auditor (CPMA) - American Academy of Professional Coders (AAPC) or another AAPC recognized credential, or billing within 1 Year (Required) Company Description To learn more about being a team member with Riverside Health System visit us at Riverside Health System Careers .