• Support the organization of security policies and documentation • Assist in identifying and tracking risks • Help collect evidence for audits • Provide support in preparing reports and controls • Assist initiatives related to LGPD and security best practices

• Set submission strategy and operational timelines in partnership with Regulatory Strategy and the cross‑functional teams. • Lead the operational planning and execution of global regulatory submissions (INDs/CTAs, NDAs/MAAs, post‑approval lifecycle submissions, HA interactions). • Oversee submission formatting, publishing, QC and archival in accordance with global standards. • Build, evolve, and manage the Regulatory Operations infrastructure, including processes, standards, templates, and best practices. • Own and optimize regulatory systems (RIM, publishing tools, controlled document systems), driving automation and efficiency. • Partner with IT, QA, and system vendors to ensure appropriate lifecycle control for regulated systems. • Maintain submission metrics and compliance tracking, including periodic reviews of archives, submission history, and audit trails. • Lead the creation, implementation, and maintenance of RA SOPs, Work Instructions, and templates to ensure standardization and inspection readiness. • Establish and oversee training on RA procedures and submission standards. • Support inspections/audits, and partner with QA to address inspection findings, ensuring continuous improvement in alignment with quality system principles. • Build and lead a high‑performing regulatory operations team, oversee submission operating model and resource planning. • Manage external vendors (publishing partners, systems providers, CROs) to ensure quality and performance aligned with company expectations. • Partner with Regulatory Strategy to ensure alignment of operational plans. • Serve as a key liaison with CMC, Clinical, PV, and Medical Writing to ensure efficient preparation of submission‑ready content. • Collaborate closely with QA on procedural governance and RA‑related training.

About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit www.CareAccess.com. How This Role Makes a Difference Care Access is seeking a skilled and experienced Specialist, Study Training Compliance and DOA Matrix Management, to join our dynamic Central Support Operations team, part of the Global Expansion and Study Operations department. The Specialist, Study Training Compliance and DOA Matrix Management within Central Support Operations team supports critical compliance functions to ensure study training requirements and delegation matrices are accurately managed across clinical research studies. This role contributes to site staff readiness and regulatory adherence by tracking training completion, maintaining essential clinical staff records, and ensuring Delegation of Authority (DOA) matrices are complete, reviewed, and approved in accordance with standard processes. The ideal candidate is organized, responsive, and passionate about maintaining quality in a regulated, fast-paced environment. How You'll Make An Impact - Study Training Compliance - Track and monitor clinical staff training completion, including study-specific and mandatory compliance training. - Support delegation processes during study start-up by verifying that training aligns with assigned roles. - Ensure documentation of training is complete, current, and meets ICH-GCP, SOP, and sponsor requirements. - Delegation of Authority (DOA) Coordination - Support DOA matrix setup and maintenance by confirming training completion and role assignments. - Work cross-functionally to ensure delegation readiness for protocol activities and study transitions. - eISF & Documentation Management - Upload and maintain essential staff training records, certifications, and staff documents in the eISF and associated systems. - Ensure that site staff training records are audit-ready and aligned with regulatory and sponsor expectations. - Support internal audits, monitoring visits, and sponsor document requests. - General Support & Collaboration - Collaborate with internal stakeholders to support study training and access coordination across study phases. - Participate in team meetings and contribute to documentation and communication tools to enhance team efficiency. - Escalate issues or delays to senior team members as appropriate to ensure study and site compliance timelines are met. - Communicate effectively with internal staff, sponsors, and vendors regarding compliance tasks and timelines. - Assist in problem-solving training, or access issues, contributing to solutions in collaboration with the broader team. - Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required - Understanding of clinical research operations and the importance of compliance and documentation. - Strong organizational and tracking skills; detail-oriented with the ability to manage multiple tasks effectively. - Comfortable working with technology platforms (e.g., Clinical Conductor, Florence, SIP); Microsoft Office proficiency required. - Strong interpersonal and communication skills for cross-functional teamwork. - Ability to work both independently and as part of a collaborative team. - Professional and adaptable when interacting with providers, vendors, and sponsor representatives. - Knowledgeable in Microsoft Office applications, particularly Excel, Word, Outlook, and SharePoint; familiarity with internet-based research and database systems is essential. - Strong interpersonal and customer service skills, with the ability to interact professionally with healthcare providers, internal staff, and external business partners. Certifications/Licenses, Education, and Experience: - Bachelor’s degree in Life Sciences, Health Administration, or a related field preferred. - Minimum of 2 years of experience in a Central Support or clinical research support role at Care Access or within a comparable organization (in clinical research, training compliance, operations, or document management in a regulated environment). - Proven experience supporting onboarding, training compliance, and/or access coordination in a regulated research environment. - Demonstrated ability to navigate and work within compliance-driven systems and support multi-trial documentation workflows. - Familiarity with eISF (Florence) and clinical training platforms is a plus. How We Work Together - Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment. - Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role. - Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $60,000 - $80,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) - Paid Time Off (PTO) and Company Paid Holidays - 100% Employer paid medical, dental, and vision insurance plan options - Health Savings Account and Flexible Spending Accounts - Bi-weekly HSA employer contribution - Company paid Short-Term Disability and Long-Term Disability - 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com Mandatory Employer Disclosures: Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction. Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment. Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment. Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws. Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.

Requisition Number: 2347814 Optum Insight is improving the flow of health data and information to create a more connected system. We remove friction and drive alignment between care providers and payers, and ultimately consumers. Our deep expertise in the industry and innovative technology empower us to help organizations reduce costs while improving risk management, quality and revenue growth. Ready to help us deliver results that improve lives? Join us to start Caring. Connecting. Growing together. Optum Insight is seeking a strategic and highly collaborative leader to serve as the VP of Government Programs & HHS Strategic Coordination. This role will coordinate enterprise-wide efforts across Optum Insight, Optum Health, Optum Rx, and UnitedHealthcare on key product and technology initiatives responding to the U.S. Department of Health & Human Services (HHS), including CMS, CMMI. You'll enjoy the flexibility to work remotely * from anywhere within the U.S. as you take on some tough challenges. For all hires in the Minneapolis or Washington, D.C. area, you will be required to work in the office a minimum of four days per week. Primary Responsibilities: Translate emerging policy, rulemaking, and innovation into actionable product strategies across Optum businesses Partner with product, growth, regulatory and market leaders to shape enterprise positions that both influence and anticipate regulatory direction. Serve as a strategic connector between HHS/CMS stakeholders and Optum product teams to ensure regulatory insight informs solution design Policy, Proposed Rule, RFI/RFP, and Federal Opportunity Alignment Internal Communication & Governance You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in. Required Qualifications: Preferred Qualifications: Demonstrated background in federal health IT policy or CMS transformation initiatives Experience with federal RFIs/RFPs Demonstrated familiarity with Optum Insight products Unified enterprise coordination on HHS/CMS initiatives Ability to strengthen federal relationships Proactive identification of opportunities and risks High-quality communication and streamlined processes *All employees working remotely will be required to adhere to UnitedHealth Group's Telecommuter Policy Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives. The salary for this role will range from $159,300 to $273,200 annually based on full-time employment. We comply with all minimum wage laws as applicable. Application Deadline: This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants. At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission. UnitedHealth Group is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations. UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.