• Facilitate improvement system-wide in the overall quality, completeness, and accuracy of the medical record documentation through extensive audit investigation, education and data analysis • Responsible for identification of patterns, trends, and opportunities for the entire CDI team, at all acute care facilities, to improve accuracy and outcomes • Responsible for assisting with large retrospective audits, at the request of hospital clients system-wide, and for educating physicians, if needed • Audits case reviews and queries of Clinical Documentation Specialists (CDIS) to ensure quality and compliance, using audit tools developed • Tracks, trends, and reports audit findings for each Clinical Documentation Specialist (CDIS), Hospital Region, and System-wide to Director/management team • Identifies knowledge gaps and provides clear explanations and interpretations on missing, unclear, conflicting, or non-compliant information captured by the CDIS • Researches, investigates and remains up to date on both clinical and coding guidelines in quarterly Coding Clinics as they relate to physician documentation improvement needed, in an ICD-10 coding environment • Assists in overall quality, timeliness and completeness of the quality health record to ensure appropriate data, provider communication, and quality outcomes • Serves as a resource for appropriate clinical documentation • Develops presentation material and provides training and education to physicians and CDIS staff as needed in an effort to strengthen documentation practices and ensure accurate coding that reflects the severity of illness (SOI) and risk of mortality (ROM) of patients they serve • Responsible for using audit tools to conduct clinical quality audits • Develops and updates policies and procedures around the CDIS audit function; and refines audit tools as needed in collaboration with Director/management team • Collaborates with leadership to conduct focused post-discharge documentation and coding audits as requested by hospital clients system-wide • Ensures safe care to patients, staff and visitors; adheres to all Memorial Hermann policies, procedures, and standards within budgetary specifications including time management, supply management, productivity and quality of service • Promotes individual professional growth and development by meeting requirements for mandatory/continuing education and skills competency; supports department-based goals which contribute to the success of the organization; serves as preceptor, mentor and resource to less experienced staff • Demonstrates commitment to caring for every member of our community by creating compassionate and personalized experiences • Models Memorial Hermann’s service standards by providing safe, caring, personalized and efficient experiences to patients and colleagues

• Perform data/referencing quality check of scientific/medical assets • Review content and identify any non-compliances with local regulatory guides • Perform actions in the Review and Approval platform (Veeva Vault) • Check anchors/links to references required for scientific/medical assets • Identify assets that may require pre-alignment with internal stakeholders • Flag claims that may be difficult to substantiate or do not follow guidelines • Track asset quality data for internal and external reporting

Role Description Within the Global Rare Diseases, R&D, Regulatory Affairs and reporting to the VP, Global Regulatory Affairs, Global Rare Diseases the Principal Regulatory Writer is responsible for authoring, reviewing, and managing regulatory documents that translate clinical, nonclinical and CMC data into clear, accurate, and compliant submissions for global health authorities (e.g., FDA, EMA, MHRA, NMPA, Health Canada), supporting both initial marketing applications and post‑approval lifecycle activities for drugs and biological products. They serve as a central member of cross‑functional regulatory submission teams, working in close collaboration with: - Global and Regional Regulatory Leads - Clinical Development - Biostatistics - Safety/Pharmacovigilance - CMC - Medical Affairs - External partners They are accountable for document development across the full product lifecycle, including: - Original applications - Variations/supplements - Responses to regulatory questions - Periodic updates - Other post-approval life cycle management documents They provide coordination, oversight, and guidance for regulatory writing activities across Global Rare Disease (GRD) development programs, ensuring harmonization of messaging and adherence to global standards. You will be responsible for: - Overseeing the drafting, review, and finalization of key regulatory and clinical documents, including but not limited to: - CTD Module 1 and 2 documents, including: - 1.6.1 and 1.6.2 (Meeting requests and packages) - 2.4, 2.5, 2.7.3, 2.7.4, 2.7.5, 2.7.6 (e.g. Nonclinical and Clinical summaries and overviews) - Addenda, updates, consolidation, alignment of Module 2 documents required to support post‑approval variations, extensions, or annual benefit–risk reassessments - Regulatory response documents, including responses to Questions, Information Requests, Requests for Information (RFIs), Major Objections, Clarifaxes, and List of Outstanding Issues - Documents required for clinical development and post-approval life cycle management, including clinical study protocols, clinical study reports, investigator’s brochures - Expedited and Special Program applications (e.g. Orphan Designation Requests, Rare Pediatric Disease Designation Requests, RMAT, Breakthrough, Fast Track, PRIME, Sakigake, Priority Review Voucher Requests) - Ensuring all regulatory documents are fully compliant with eCTD specifications and applicable regional and international guidelines (e.g., ICH, FDA, EMA) - In collaboration with Global Regulatory Leads and Regional Regulatory Leads, supporting timely and high‑quality dossier assembly and submission, managing document timelines and cross‑functional inputs - Maintaining awareness of current and evolving global regulatory requirements, proactively incorporating regulatory intelligence into authored submissions - Providing subject-matter expertise and leadership in the development, maintenance, and implementation of role‑relevant tools, SOPs, work instructions, templates, and style guides - Coordinating and managing external regulatory writers and internal subject matter experts, ensuring quality, consistency, and adherence to agreed timelines for marketing authorization and lifecycle submissions - Training and guiding cross‑functional contributors on best practices for regulatory writing, including adherence with Chiesi standards and styles, document structure, data presentation, traceability, and version control - Contributing to resource planning, ensuring adequate FTE and budget support to meet program and organizational regulatory writing needs Qualifications - Relevant life science university degree, PhD or Pharm. D in Biochemistry, Pharmacology, or a related field. RAC Preferred - Demonstrated experience authoring and/or leading the development of regulatory documents across the drug development lifecycle, such as: - Health Authority Meeting Requests, Packages, Briefing Documents - Critical / Key Module 1 documents - Nonclinical and Clinical Overviews and Summaries (CTD Module 2) - Response documents to regulatory authorities - Expedited and Special Program Requests and Designation Packages (e.g. Orphan Drug Designation Requests, Fast Track, Prime, RMAT, Breakthrough, Sakigaki, etc.) - Clinical Trial Applications/Dossiers (e.g., IND, CTA, NDA/BLA modules) - Background knowledge in rare diseases is highly desirable - Fluent in both the written word and spoken English Requirements - Strong familiarity with global regulatory frameworks and expectations, including FDA and EMA requirements - Advanced knowledge of ICH guidelines governing regulatory document structure, format, and content, including but not limited to ICH E3, E6, E9, and M4 - Strong understanding of the end to end drug development process, regulatory strategy considerations, and the informational needs of internal and external stakeholders - Proficient in interpreting complex clinical and statistical data, with the ability to present results clearly, convincingly, and concisely in a regulatory context - Advanced proficiency in MS Office applications (Word, PowerPoint, Excel, Teams) and Adobe Acrobat, including document formatting, review, and alignment with eCTD requirements to facilitate efficiency in the publishing of regulatory submissions Soft Skills - Exceptional written and verbal communication skills, with the ability to convey complex scientific and regulatory concepts clearly to both technical and non-technical audiences - Highly organized and proactive, with the ability to manage multiple deliverables under tight timelines while maintaining high standards for quality and compliance - Excellent attention to detail, including data consistency, traceability, and alignment across submission documents - Proven ability to build, guide, and maintain cohesive and collaborative teams, including mentoring junior writers and contributors (candidates with leadership development aspirations will be considered) - Strong motivation, coordination, and conflict resolution skills within a matrixed, cross-functional environment - Excellent problem-solving skills and the ability to work both independently and collaboratively in multidisciplinary teams Benefits - The minimum salary for this role is €59.040, aligned to our established salary framework - This role is eligible to participate in an annual bonus scheme, subject to company and individual performance - Comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme - Flexible working arrangements, remote work options, and tax assistance services for foreign colleagues Location The role can be based in the HQ in Parma or in one of Chiesi affiliates in Europe. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws.

Role Description The Senior Utilization Review Specialist (SURS) provides administrative support and management to Within and clients. Additionally, the URS works collaboratively with insurance companies and clinical staff. - Maintain efficient methods for ensuring the medical necessity and appropriateness of prescribed level of care. - Oversee the entire UR process for client journey from admission to discharge. - Complete precertification process and associated documentation. - Audit charts to ensure content reflects medical necessity guidelines. - Ensure continued stay reviews are completed, accurate, and timely. - Assist clinical staff with appeals when necessary. - Provide support to clinical staff around the UR process. - Train new clinical staff on UR process and procedures including documentation of medical necessity. - Provide ongoing training for existing staff on UR and documentation. - Submit initial assessments, continued stay assessments, and payer requested reviews following the established policies and governing regulations. - Communicate with commercial payers per request of payer and Within policy. - Issue complete and concise communications, submitting the critical elements that establish medical necessity. - Follow-up on approval/denial if no reply is received within 12-24 hours by telephone or payer portals. - Document all actions and activities in the case management and billing management systems. - Advise clinical staff on peer review and/or appeals process and provide oversight when necessary. - Communicate with Admissions Specialists and other members of the Clinical team to ensure effective collaboration. - Compile reports and statistics for presentation to the Utilization Review Committee upon request. - Other duties assigned by the supervisor. Qualifications - Experience in a business or health-related field or an equal combination of education and applicable experience within a higher level of care eating disorders setting. - Minimum of 1 year experience performing insurance verification, utilization review or intake assessments in a Residential Treatment Center (RTC), Partial Hospitalization Program (PHP) and/or Intensive Outpatient Program (IOP) environment, eating disorders setting preferred. - Ability to assist in the development and process improvement of obtaining payor authorization and concurrent appeals. - Manages time effectively, setting priorities, and consistently meeting deadlines. - Ability to effectively interact with insurance companies. - Demonstrates initiative and proactive approach to problem resolution. - Can perform well independently and on a team. - Assumes accountability for behaviors consistent with the customer service policy. - Competent in computer based charting, clinical, and non-clinical software programs. - Understands commercial coverage details. - Operates office equipment efficiently. - Demonstrates appropriate judgment and discretion in the UR Coordinator role. Requirements - Must have reliable internet connection. - Must be comfortable operating a computer and smart-phone and navigate applications within macOS and iOS. - Must be comfortable communicating with colleagues via chat, telephone, and video calls. - Must be able to sit for the majority of the shift. - This is a work-from-home position. Work should be performed in a private, quiet space with minimal background noise. Benefits - Competitive compensation package including salary commensurate with experience. - Remote work flexibility with a results-driven culture. - Comprehensive health benefits that reflect our commitment to wellbeing. - The chance to directly transform lives and makes treatment accessible. - Collaborative and innovative work environment with a team passionate about our mission. - Professional development opportunities and support for continued growth.