Alignment Health is breaking the mold in conventional health care, committed to serving seniors and those who need it most: the chronically ill and frail. It takes an entire team of passionate and caring people, united in our mission to put the senior first. We have built a team of talented and experienced people who are passionate about transforming the lives of the seniors we serve. In this fast-growing company, you will find ample room for growth and innovation alongside the Alignment Health community. Working at Alignment Health provides an opportunity to do work that really matters, not only changing lives but saving them. Together. The Manager of Compliance & Delegate Oversight Reporting & Analytics will serve as the analytical and reporting leader responsible for ensuring visibility, accountability, and regulatory alignment across internal operations and delegated entities (e.g., provider groups, vendors, and MSOs). This role is a working manager. The Manager will oversee delegate monitoring frameworks, reporting tools, and compliance analytics that support regulatory requirements, mitigate risk, and strengthen operations’ audit readiness. This role partners closely with Compliance, Delegation Oversight, Operations, Quality, Legal, Optimization, and external delegates to ensure performance expectations are defined, measured, and actionable. The Manager is expected to operate strategically while being hands-on in producing reporting, performing root-cause analysis, and developing insights that drive compliance and operational improvement. Job Responsibilities: - Own the analytics, reporting, and performance monitoring framework for both internal operations and delegated entities to support regulatory compliance and oversight requirements. - Serve as a hands-on contributor in developing reports, dashboards, and analytics — including writing queries, building visualizations, and synthesizing insights for performance improvement. - Lead the development and maintenance of dashboards and scorecards that measure delegate performance, contractual compliance, corrective action progress, and operational risk indicators. - Partner with Compliance, Delegation Oversight, and Operations teams to define expectations, metrics, and escalation criteria for delegate monitoring. - Conduct root cause analysis and trend evaluations on compliance issues, audit findings, or delegate performance gaps, providing data-backed recommendations for corrective action. - Translate regulatory, contractual, and audit requirements into measurable analytic and reporting structures. - Prepare and validate data and reports to support CMS, state, or internal audits and readiness reviews, including universe build development and reconciliation. - Serve as a subject matter expert on compliance reporting definitions, data structures, and methodologies. - Lead, develop, and manage a team of analysts — assigning work, reviewing deliverables, coaching skill development, and building analytical rigor. - Work with BI, Data Engineering, and IT teams to improve data access, reporting automation, and governance of compliance data sources. - Present findings and risks to leadership and cross-functional stakeholders with clear storytelling and recommended actions. - Other duties and projects not listed above. Supervisory Responsibilities: Manage a team of analysts while also contributing as a hands-on individual contributor. Responsibilities include hiring, training, mentoring, performance management, and establishing analytical standards across the team. Job Requirements: Experience: Required: - 5+ years of experience in healthcare analytics, compliance reporting, regulatory oversight, or delegated entity monitoring. - 2+ years of experience leading analysts or project teams, preferably in a working manager or hybrid leadership role. - Demonstrated experience producing reporting and insights in regulated environments (Medicare Advantage preferred). Preferred: - Experience supporting CMS program audits, reporting submissions, delegation oversight reviews, or corrective action plans. - Experience monitoring delegated entity performance across functions such as claims, encounters, provider data, UM, appeals/grievances, etc. Education: Required: - Bachelor’s degree in Data Analytics, Business, Public Health, Information Systems, Healthcare Administration, or a related field. 4+ additional years of related experience can be used in lieu of a degree. Preferred: - Master’s degree. Training: Required: n/a Preferred: Compliance or regulatory training, delegated oversight, or formal training in Medicare Advantage program requirements. Specialized Skills: Required: - Proficiency in SQL and/or BI tools (Power BI, Tableau, etc.) — including hands-on report and dashboard development. - Ability to translate regulatory and contractual requirements into measurable KPIs and reporting structures. - Strong analytical and critical-thinking skills, including ability to independently investigate issues and synthesize insights. - Excellent written and verbal communication skills, including the ability to present risk, compliance trends, and recommendations to leadership. - Ability to manage multiple priorities and deadlines in a high-visibility environment. Preferred: - Experience with automation, report scheduling, or data quality validation workflows. - Familiarity with CMS reporting and other regulatory / delegation standards. - Exposure to enterprise data governance, MDM standards, or audit frameworks. Licensure: Required: none Preferred: none Essential Physical Functions: 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. 1. While performing the duties of this job, the employee is regularly required to talk or hear. The employee regularly is required to stand, walk, sit, use hand to finger, handle or feel objects, tools, or controls; and reach with hands and arms. 2. The employee frequently lifts and/or moves up to 10 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus. Pay Range: $130,332.00 - $195,498.00Pay range may be based on a number of factors including market location, education, responsibilities, experience, etc. Alignment Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity, or sexual orientation. *DISCLAIMER: Please beware of recruitment phishing scams affecting Alignment Health and other employers where individuals receive fraudulent employment-related offers in exchange for money or other sensitive personal information. Please be advised that Alignment Health and its subsidiaries will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for employment with our company. If you feel that you have been the victim of a scam such as this, please report the incident to the Federal Trade Commission at https://reportfraud.ftc.gov/#/. If you would like to verify the legitimacy of an email sent by or on behalf of Alignment Health’s talent acquisition team, please email careers@ahcusa.com.

Role Description The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as: - Core/Site document collection and approval - ICF customization and approval - IRB/EC and CA/ MoH submissions - Delivery of quality IMP release packages Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities. Essential functions of the job include but are not limited to: - Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery. - Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution. - Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation. - Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up. - Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines. - Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels. - Responsible to co-ordinate translations for documents required for submissions. - Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables. - Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country. - If needed, directly support country or site level activities start up activities. - Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors. - Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries. - Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL. - Interact with clients in proposal activities, including slide development and client presentation as required. Qualifications - Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience. - 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. - 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities. Requirements - Demonstrated leadership experience in driving cross-functional activities. - Excellent communication and organizational skills are essential. - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. - Fluency in English and for non-English speaking countries the local language of country where position based. - Experience using milestone tracking tools/systems. Benefits - We strive to ensure employees feel appreciated for the contributions they make every single day. - You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

• Assist with preparing and verifying data for internal and external audits, ensuring accuracy and completeness. • Monitor data integrity within client and staff databases, reporting any potential discrepancies. • Compile reports and documents according to established guidelines. • Support audits and investigations, including scheduling, documentation, and communication. • Assist with communicating and upholding policies, procedures, and expectations to staff. • Responsible for the maintenance and distribution of client records in accordance with HIPAA regulations. • Facilitate the timely and accurate processing of incoming requests and information for various projects, workflows and initiatives. • Resolve daily and routine nature issues as well as exercise appropriate judgment for escalation.

POSITION SUMMARY Position Title: Regulatory Affairs Associate II Contractor Reports to: Senior Manager, Regulatory Affairs Status: Contractor Location: South San Francisco, CA/Remote Summary: The Regulatory Affairs Associate II Contractor supports regulatory activities across Assembly Biosciences’ development programs, including regulatory operations, document management, and meaningful contributions to regulatory strategy for assigned projects. This role is primarily responsible for tracking regulatory deliverables, maintaining document repositories and archives, and assisting with submission readiness and lifecycle management activities under direct supervision. The Associate will collaborate with cross-functional teams to ensure regulatory documents are complete, accurate, and readily available to support regulatory submissions and ongoing compliance. Specific responsibilities include, but are not limited to: - Tracking regulatory deliverables, milestones, and timelines across development programs to ensure visibility and on-time completion. - Maintaining regulatory document repositories (e.g., Veeva RIM, Veeva eTMF) including version control, accuracy checks, and archival of final documents. - Performing detailed document quality checks (QC) to ensure formatting, completeness, and adherence to FDA eCTD specifications and internal SOPs. - Supporting regulatory publishing activities, including document compilation, formatting, and hyperlinking/bookmarking under guidance. - Coordinating with cross-functional teams (CMC, Clinical, Quality) to collect and organize required submission deliverables. - Assisting in the preparation and maintenance of submission trackers, document lists, and regulatory correspondence logs. - Supporting post-submission activities, including filing of regulatory correspondence and tracking of queries/responses. - Contributing to the maintenance of Regulatory Operations processes, templates, and SOPs to enhance efficiency and compliance. - Supporting inspection and audit readiness by ensuring regulatory records are organized and readily retrievable. - Supporting transfer of regulatory documents to external partners as needed. - Periodically conducting eTMF reviews for Regulatory and Safety documents This job description outlines the primary duties and responsibilities of the role; however, it is not intended to be all-inclusive. The scope of responsibilities may be modified, expanded, or adjusted at the discretion of the organization to meet evolving business needs. Qualifications Include: - Bachelor’s degree in Life Sciences, Regulatory Affairs, or a closely related field combined with 2+ years of experience in regulatory affairs or equivalent. - Proficiency in Microsoft Office Suite (Word, Excel) and Adobe Acrobat for document handling. - Strong organizational skills with meticulous attention to detail and a high degree of accuracy. - Ability to manage multiple deliverables and meet tight deadlines in a fast-paced environment. - Clear and professional written and verbal communication skills - Experience with Smartsheets, Veeva RIM and eTMF preferred Pay Range: $48 - $58/hour The stated pay range for this position reflects the San Francisco Bay Area job market. Assembly Bio establishes pay ranges based on geographic work locations. Additional factors such as academic credentials and relevant experience will influence the actual salary offered. About Assembly Bio Assembly Bio (NASDAQ: ASMB) is an ambitious biopharmaceutical company with cutting- edge therapeutic clinical candidates capable of improving the lives of millions living with chronic hepatitis B virus (HBV) infection around the world, and research and preclinical programs focused on the discovery of novel antivirals to treat devastating viral diseases, including HBV, hepatitis delta virus (HDV) and herpesviruses. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We set our sights high—and pursue our goals with determination. Our unique organization stands ready to welcome talented, motivated individuals, who share our ambitions. As an equal opportunity employer, we are committed to diversity and inclusion and will not tolerate discrimination and harassment of any kind. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Information for Recruitment Agencies Assembly Bio does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or Assembly Bio employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search. Your willingness to comply with this will significantly impact any decision we may make about doing business with you. Location South San Francisco, California (Remote) Department 250 Regulatory & Quality Assurance Employment Type Contractor Compensation $48 - $58/hr