Regulatory affairs manager full time jobs

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal and external stakeholders for GRAIL projects, including Multi-Cancer Early Detection (MCED). The position supports the U.S. Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual reports, and other relevant documentation. The role collaborates cross-functionally with Quality, Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market product support, and change control processes. This individual monitors and communicates changes in regulatory policies and In Vitro Diagnostic (IVD) requirements to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. The role fosters a work culture aligned with GRAIL's values This job requires that a minimum of 60% or 3 days of the total work week be onsite in Durham, NC. **Responsibilities:** + Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings. + Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies. + Provide regulatory support for both new and marketed Laboratory Developed Test (LDT) products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor and report on international regulatory developments and LDT requirements that may significantly impact business operations or customers. + Maintain up-to-date knowledge of applicable regulatory requirements and relevant scientific/technical developments. + Identify regulatory risks and propose alternative courses of action. + Assess new regulations and collaborate with internal teams to implement appropriate changes. + Support internal and external quality audits. + Ensure compliance with all regulations and laws applicable to GRAIL's business, providing guidance and recommendations. + Review and approve regulatory strategy documents, regulatory plans, procedures, SOPs, and other documents for alignment with commitments, regulations, and filings. + Manage the creation and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required Qualifications:** + **Experience** + Minimum of 10 years of experience in regulatory, development, clinical affairs, quality, or program management within the IVD, medical device, or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions in the EU, Japan, China, Canada, and other international markets is preferred. + Background in diagnostics or biomarker development, particularly in oncology, is a plus. + Advanced scientific degree preferred. + Regulatory Affairs Certification (RAC) preferred. + Experience in pharmaceutical clinical, statistical, or regulatory settings-especially in oncology, immunology, or related fields-is a plus. **Knowledge, Skills, and Abilities** + Proven leadership and sound judgment with strong business partnering skills. + Demonstrated knowledge of U.S. and international regulatory frameworks and processes for medical device development and approvals. + Effective collaborator in dynamic, fast-paced, and evolving environments. + Problem-solving mindset with the ability to work well across diverse teams. + Strong written and verbal communication skills. + Excellent organizational skills and attention to detail. Expected full time annual base pay scale for this position is $164K-$205K. Actual base pay will consider skills, experience and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at *************** if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights (**************************** ' poster. We welcome job-seekers from all backgrounds to join us!

Full Time Columbus, OH AndHealth is on a mission to radically improve access and outcomes for the most challenging chronic health conditions with the goal of making world-class specialty care accessible and affordable to all. We partner with health systems, community health centers, plans, and employers to remove barriers to care to ensure all people have access to the care they deserve. As a Director of Compliance, you will play a key role in supporting our compliance and privacy efforts across AndHealth. This position will ensure AndHealth operates in alignment with all applicable laws, regulations, and internal policies. This role will work closely with senior leadership and other departments to foster a culture of integrity and compliance throughout the organization. What you'll do in the role: Compliance: Manage a comprehensive corporate compliance program, including policies, training, auditing, monitoring, investigations, and reporting functions. Support the company in maintaining compliance with applicable local, state and federal regulatory requirements relevant to healthcare by collaborating with Legal and internal stakeholders. Monitor regulatory and policy changes and assess their impact on the business. When applicable, work with leadership and Legal to enhance policies, standard operating procedures, and systems to align with changes. Create, review, and update internal compliance policies and procedures. Conduct periodic internal audits and compliance risk assessments to identify and mitigate potential risks. Work with departments to implement, when necessary, corrective actions and monitor effectiveness to prevent future occurrences. In collaboration with Legal, conduct annual reviews and updates of business terms, including terms of use, privacy policies, and other published terms for accuracy and compliance. Collaborate with Information Technology to support periodic security risk assessments and to maintain company's incident response process, including investigations, final reporting, and leadership readouts. Oversee training and education programs related to compliance and ethics for all employees and contractors. Participate in the Specialty Pharmacy Services Quality Management Committee. Act as the designated compliance officer exclusively for the Specialty Pharmacy Services team. Act as primary liaison with community health center partners for compliance. Develop and maintain the compliance document infrastructure, ensuring accessibility and annual updates relevant to policies and standard operating procedures. Build and nurture positive relationships with other employees across the company and with outside regulators and serve as the compliance and privacy ambassador for the company. Privacy Oversight Serve as the primary in-house HIPAA privacy expert, ensuring safety and integrity of protected health information (PHI) across all platforms, services, and operations. Develop, implement, and manage privacy-related policies, training programs, and HIPAA awareness initiatives, including company-wide annual training and attestation processes. Lead and document privacy incident and breach investigations, including coordinating with Legal, regulatory reporting, executive communication, and oversight of incident response efforts. Oversee periodic internal and vendor privacy audits, ensuring optimal privacy practices and industry best practices. Collaborate cross-functionally with Legal, Product, Clinical, and other teams to perform privacy risk assessments, review and maintain consent forms (including patient testimonials), and address privacy risks in business processes and technology Contribute to updates and notices of privacy practices and review use of patient testimonials and patient data for compliance with consent and privacy expectations. Align privacy policies and risk management processes with broader security frameworks (e.g., SOC 2), in partnership with the Director of Information Technology. Contribute to the vendor procurement process by reviewing vendor documentation and checklist from a privacy and compliance perspective. Education & Licensure Requirements: Bachelor's degree in law, Business Administration, Finance, or a related field. A master's degree or professional certification (e.g., Certified Compliance & Ethics Professional - CCEP) is a plus. Other Skills or Qualifications: 5+ years of experience in compliance, legal, or regulatory roles (healthcare, provider practices, or healthcare technology environments are a plus). Familiarity with HIPAA, HITECH, Anti-Kickback Statutes, and other relevant healthcare regulations. Excellent communication and interpersonal skills, with the ability to interact with all levels of staff and management. Strong analytical and problem-solving abilities. Strong attention to detail, organizational skills, and the ability to manage multiple tasks in a fast-paced environment. Proficiency in compliance-related software and tools. Here's what we'd like to offer you: Equal investment and support for our people and patients. A fun and ambitious start-up environment with a culture that takes on important things, takes risks, and learns quickly. The ability to demonstrate creativity, innovation, and conscientiousness, and find joy in working together. A team of highly skilled, incredibly kind, and welcoming employees, every one of whom has something unique to offer. We know that the overall success of our business is a collaborative effort, and we strive to provide ongoing opportunities for our employees to learn and grow, both personally and professionally. Full-time employees are eligible to participate in our benefits package which includes Medical, Dental, Vision Insurance, Paid time off, Short- and Long-Term Disability, and more. Work Environment: The work environment characteristics described here are representative of those encountered while performing the essential function of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. 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 person the essential functions. While performing the duties of this job, the employee is regularly required to sit, stand, talk, visualize, or hear. We are an equal opportunity and affirmative action employer. We embrace diversity and are committed to creating an inclusive environment for all employees. Applicants will be considered for employment without regard to race, religion, gender, gender identity, sexual orientation, national origin, age, disability, or veteran status.

The Associate, External Affairs is responsible for assisting the External Affairs team with strategies stemming from the Community Relations Committee and Government Relations Committee, as well as efforts to combat antisemitism. In this capacity the Associate, External Affairs will be responsible for assisting to work on a broad range of issues and representing the Jewish community to the non-Jewish community. This position is full-time and reports to the Assistant VP, External Affairs. ESSENTIAL JOB FUNCTIONS Position the Jewish Federation of Cleveland as a convener for the Cleveland Jewish community's public affairs agenda. Partner in strategic thinking for the Federation to implement and scale a broad antisemitism plan. Assist in the execution of strategy, tactics, and partnerships to move forward these efforts. Assess the current climate and develop a roadmap to proactively combat antisemitism locally in K-12 schools and universities. Work with local member agencies on their grant processes related to security and other types of available funding at the federal, state, county, and city level. Serve as a resource on public affairs issues and activities to Federation stakeholders, including volunteer leadership and others. Develop and maintain relationships within the general and Jewish community for mutually beneficial programming and coalition-building, in conjunction with Government Relations. ADDITIONAL DUTIES/RESPONSIBILITIES 10% of the position is allocated to an annual Campaign assignment; this may include, but is not limited to, providing staff support to a group of Campaign volunteers, planning and executing a specific Campaign strategy, and participating in regular Campaign meetings and events, as determined by the Campaign Director. QUALIFICATIONS Knowledge, Skills, Abilities and Personal Characteristics: Creative and strategic thinker. Demonstrated success implementing short- and long-term strategic activities and tasks with clear goals, objectives and measurement tools. Knowledge of current affairs topics of interest to the Jewish community, including Israel. Possess a passionate commitment to the Jewish community and relevant public policy issues. Strong knowledge and understanding of Jewish practices, customs, history, and community infrastructure. Excellent written communications skills Ability to manage project/program budgets and timelines. Ability to set priorities and handle multiple tasks and strong organizational skills. Ability to work irregular hours, including periodic evenings and weekends as necessary to attend relevant events and programs. Education, Training and/or Experience: Bachelor's degree required; master's degree preferred. 1-3 years of experience in community relations, government relations, Jewish communal work, public policy and/or advocacy. ABOUT THE FEDERATION The Jewish Federation of Cleveland is the only organization in Cleveland that focuses on the health and vitality of the entire Jewish community. For more than 120 years, the Federation has created the critical scale necessary to drive meaningful social change and provide relief in times of crisis in ways no one person or organization could do alone. As Jewish Cleveland's hub for innovative solutions and collaborative services, the Federation is able to change and improve lives in Cleveland, Israel, and around the world.

JobID: 210667799 JobSchedule: Full time JobShift: Base Pay/Salary: Jersey City,NJ $128,250.00-$195,000.00 Join JPMorgan Chase and bring your expertise to our Risk Management and Compliance team. You will play a central role in maintaining the strength and resilience of JPMorgan Chase by helping the firm grow responsibly. This involves anticipating new and emerging risks and using your expert judgment to address real-world challenges that impact our company, customers, and communities. Our culture in Risk Management and Compliance encourages thinking outside the box, challenging the status quo, and striving to be best-in-class. As a Compliance Risk Management Lead within the Compliance, Conduct, and Operational Risk organization, you will be a part of the Global Financial Crimes Compliance (GFCC) Consumer and Community Banking (CCB) Team responsible for effectively partnering with the Line of Business (LOB) and global/regional Compliance teams; including Internal Audit, Operational Risk and other Control functions. Your role requires knowledge and experience in Compliance as well as familiarity with regulatory and/or audit best practices. Additionally, you may provide Compliance coverage for several areas in addition to serving as the team's subject matter expert for specific regulations in executing the following Core Practices: Governance and Oversight, Regulatory Management, Policies and Procedures, Training and Awareness, Monitoring and Testing, Issue Management, Risk Assessment and Reporting, and Risk Control Self-Assessment. Job Responsibilities * Perform analysis to identify major issues and actionable opportunities and design potential solutions * Develop management, stakeholder, and regulator presentations in order to communicate issues, recommendations, and status of initiatives * Identify potential concerns and control issues, determine the root cause of issues and ensure stakeholders develop and implement appropriate corrective actions * Oversee the LOB execution of the risk assessment and other reporting * Conduct ongoing compliance monitoring activities and participate in special projects as required * Challenge the status quo by providing critical and analytical thinking and strong decision making capabilities to identify problems, propose creative solutions, and escalate as necessary * Develop project plans and document and analyze business systems/processes Required qualifications, capabilities, and skills * Demonstrate the ability to partner with stakeholders on projects * Possess strong written and oral executive-level communications skills * Detail-oriented; possess a high-level of attention to detail and quality for their work product * Excellent analytical skills * Experience using the MS Suite of products * Ability to work both independently and as a core team member Preferred qualifications, capabilities, and skills * MBA or Bachelor's degree professional certification preferred * Professional certification preferred * CORE experience a plus with an understanding of risk and controls

JOB RESPONSIBILITIES * Protocol - Apply a comprehensive understanding of research regulations, ethics and guidelines, analyze research protocols submissions (new protocols, continuing review, changes to protocols, one-time use request and adverse events) to determine compliance with regulations. Oversee the review and correspondence of research protocols. Use independent judgment to interpret, analyze, and apply federal, state and CCHMC guidelines to promote ethical practices in research involving human subjects and to ensure compliance to those regulations by faculty and staff investigators. Work directly with individual faculty and staff investigators and research support staff to address human subjects issues during protocol review. Answer questions and problem solve for investigators, faculty, staff, research coordinators and students. Act as a liaison between IRB members and researchers to promote information flow. Prepare, review and submit all protocol amendments, SAE reports, and continuing reviews. Complete all reviews and submissions in a timely manner, meeting all deadlines. Under the guidance of senior staff, may assist in the development of protocol documents including but not limited to the protocol and consent forms. * Compliance - Upon request from investigators, conduct pre-reviews of draft documents (such as new protocol submissions, exemptions, and changes of protocol) and advise investigators and research coordinators regarding potential ethical, regulatory, editorial or content issues before they are submitted for full IRB review. Determine which research protocols or issues have additional requirements, such as the need for review by an outside expert, and coordinate the process to meet these requirements. Follow policies and procedures governing the handling of confidential information as defined by Cincinnati Children's mission and applicable laws and regulations. Review timeliness, accuracy, availability and security of information. * Process - Work daily in an audit ready manner. Organize and participate in activities to prepare for audits, surveys, quality reviews, and inspections. Participate in improving organizational performance through recommending areas or approaches for improvement activities, performing new procedures, collecting data and providing input to department discussions. Participate in staff committee, subcommittee, or special project groups. This may include research and writing, coordinating meeting schedules, preparing and distributing materials, recording minutes to document progress, and communicating the final outcome. By applying a comprehensive understanding of research and ethics, compose clear and precise memos, reports and training materials. Assist in developing written guidelines and educational materials for investigators (faculty and staff). Contribute to planning and presenting educational programs for investigators, research coordinators, and other groups. Use creative and effective presentation skills. Participate in establishing job requirements and goals; perform duties at the desired level of competency. * Procedure - Act as a resource for faculty and staff regarding regulations during research protocol review. Serve as an informational and referral resource for the research community regarding regulatory, ethical and procedural issues. Maintain currency in field through cross-training, continuing education, literature and seminars. Implement this knowledge into the department. * Documentation - Document the conduct of each protocol's regulatory activities in an electronic regulatory system.. Maintain written and electronic systems to support the clinical research activities. Submit data to collaborative parties accurately and within a timely manner. JOB QUALIFICATIONS * Bachelor's degree in a related field * 2+ years of work experience in a related job discipline Primary Location Burnet Campus Schedule Full time Shift Day (United States of America) Department Clinical Research Services Employee Status Regular FTE 1 Weekly Hours 40 * Expected Starting Pay Range * Annualized pay may vary based on FTE status $56,846.40 - $72,488.00 Market Leading Benefits Including*: * Medical coverage starting day one of employment. View employee benefits here. * Competitive retirement plans * Tuition reimbursement for continuing education * Expansive employee discount programs through our many community partners * Shift Differential, Weekend Differential, and Weekend Option Pay Programs for qualified positions * Support through Employee Resource Groups such as African American Professionals Advisory Council, Asian Cultural and Professional Group, EQUAL - LGBTQA Resource Group, Juntos - Hispanic/Latin Resource Group, Veterans and Military Family Advocacy Network, and Young Professionals (YP) Resource Group * Physical and mental health wellness programs * Relocation assistance available for qualified positions * Benefits may vary based on FTE Status and Position Type About Us At Cincinnati Children's, we come to work with one goal: to make children's health better. We believe in a holistic team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children's. Cincinnati Children's is: * Recognized by U.S. News & World Report as a top 10 best Children's Hospitals in the nation for more than 15 years * Consistently among the top 3 Children's Hospitals for National Institutes of Health (NIH) Funding * Recognized as one of America's Best Large Employers (2025), America's Best Employers for New Grads (2025) * One of the nation's America's Most Innovative Companies as noted by Fortune * Consistently certified as great place to work * A Leading Disability Employer as noted by the National Organization on Disability * Magnet designated for the fourth consecutive time by the American Nurses Credentialing Center (ANCC) We Embrace Innovation-Together. We believe in empowering our teams with the tools that help us work smarter and care better. That's why we support the responsible use of artificial intelligence. By encouraging innovation, we're creating space for new ideas, better outcomes, and a stronger future-for all of us. Comprehensive job description provided upon request. Cincinnati Children's is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/Veteran/Disability

This role is responsible for leading media compliance for Kroger Precision Marketing (KPM) at 84.51°, with a focus on ensuring adherence to emerging privacy regulations and ad tech industry standards. The Director will manage subject matter experts and collaborate with Kroger Privacy Office, law department, and other internal Kroger and 84.51° stakeholders, external media clients, and third-party vendors in the ad tech ecosystem. This position requires deep expertise in advertising technology, and retail media experience is strongly preferred. The successful candidate will demonstrate Kroger's core values of respect, honesty, integrity, diversity, inclusion, and safety.From one tiny Cincinnati grocery store more than a century ago, we've grown into what today is the nation's largest grocer with nearly 2,800 stores in 35 states operating under 28 different names. As America's grocer, we take pride in bringing diverse teams with a passion for food and people together with one common purpose: To Feed the Human Spirit. With a history of innovation, we work tirelessly to create amazing experiences for our customers, communities AND each other, with food at the heart of it all. Here, people matter. That's why we strive to provide the ingredients you need to create your own recipe for success at work and in life. We help feed your future by providing the value and care you need to grow. If you're caring, purpose-driven and hungry to learn, your potential is unlimited. Whether you're seeking a part-time position or a new career path, we've got a fresh opportunity for you. Apply today to become part of our Kroger family! What you'll receive from us: The Kroger Family of Companies offers comprehensive benefits to support your Associate Well-Being, including Physical, Emotional, Financial and more. We'll help you thrive, with access to: A wide range of healthcare coverage, including affordable, comprehensive medical, dental, vision and prescription coverage, through company plans or collective bargaining agreement plans. Flexible scheduling in full- and part-time roles with paid time off, including holiday and sick pay based on eligibility and length of service. Emotional and financial support with free counseling through our Employee Assistance Program and free, confidential financial tools and coaching with Goldman Sachs Ayco. Valuable associate discounts on purchases, including food, travel, technology and so much more. Up to $21,000 in tuition reimbursement over your career, through our industry-leading Continuing Education program. Vast potential for growth, through an abundance of industry-leading training programs and diverse career pathways. For more information about benefits and eligibility, please visit our Benefits Page ! Minimum Bachelor's degree and 7+ years of experience in data governance, risk and/or compliance experience in the media/ adtech industry 5+ years of data privacy experience Strong proficiency in advertising technology, including DSPs, SSPs, ad exchanges, ad servers, and publisher platforms Experience managing compliance programs Ability to educate and motivate associates across all levels Independent and strategic thinker with strong decision-making skills Project management experience Excellent presentation, written, and oral communication skills Proficiency in Microsoft Office (Word, PowerPoint, Excel) Desired Bachelor's degree in technical field or master's degree Ad agency and/or data technology experience Retail industry experience Lead and coordinate media compliance strategy across 84.51• and KPM Develop and execute a strategic framework and guidelines for media compliance, supervising and coaching team members Continuously improve compliance programs in response to evolving legal, regulatory, and industry landscapes Communicate the impact of regulatory changes on Kroger's media operations to senior leadership and 84.51• business stakeholders Lead cross-functional projects requiring strategic oversight and executive engagement Represent Kroger in industry forums and collaborate with peer compliance professionals Serve as a company representative on media/ad tech privacy issues Guide product, data science, and engineering teams on media compliance Oversee third-party media compliance consultants and service providers Monitor and audit compliance across the 84.51 Develop best practices for training and compliance recordkeeping Respond to compliance violations and oversee investigations and remediation Provide regular, periodic reporting on privacy media compliance efforts to the Chief Privacy Officer and other designated executives Travel independently up to 30% of the time Supervise and coach direct reports in the performance of their duties; complete performance reviews and provide feedback to direct reports Ability to work cooperatively in high paced and sometimes stressful environment Ability to manage conflict in a reasonable, nonconfrontational and cooperative manner Ability to act with honesty and integrity regarding customer and business information Ability to follow directions and seek assistance when necessary to resolve customer and business issues Provide support and assistance through direct interaction with minors, individuals with special needs, and/or older adults Must be able to perform the essential functions of this position with or without reasonable accommodation

Job DescriptionDirector, Compliance Full Time Columbus, OH AndHealth is on a mission to radically improve access and outcomes for the most challenging chronic health conditions with the goal of making world-class specialty care accessible and affordable to all. We partner with health systems, community health centers, plans, and employers to remove barriers to care to ensure all people have access to the care they deserve. As a Director of Compliance, you will play a key role in supporting our compliance and privacy efforts across AndHealth. This position will ensure AndHealth operates in alignment with all applicable laws, regulations, and internal policies. This role will work closely with senior leadership and other departments to foster a culture of integrity and compliance throughout the organization. What you'll do in the role: Compliance: Manage a comprehensive corporate compliance program, including policies, training, auditing, monitoring, investigations, and reporting functions. Support the company in maintaining compliance with applicable local, state and federal regulatory requirements relevant to healthcare by collaborating with Legal and internal stakeholders. Monitor regulatory and policy changes and assess their impact on the business. When applicable, work with leadership and Legal to enhance policies, standard operating procedures, and systems to align with changes. Create, review, and update internal compliance policies and procedures. Conduct periodic internal audits and compliance risk assessments to identify and mitigate potential risks. Work with departments to implement, when necessary, corrective actions and monitor effectiveness to prevent future occurrences. In collaboration with Legal, conduct annual reviews and updates of business terms, including terms of use, privacy policies, and other published terms for accuracy and compliance. Collaborate with Information Technology to support periodic security risk assessments and to maintain company's incident response process, including investigations, final reporting, and leadership readouts. Oversee training and education programs related to compliance and ethics for all employees and contractors. Participate in the Specialty Pharmacy Services Quality Management Committee. Act as the designated compliance officer exclusively for the Specialty Pharmacy Services team. Act as primary liaison with community health center partners for compliance. Develop and maintain the compliance document infrastructure, ensuring accessibility and annual updates relevant to policies and standard operating procedures. Build and nurture positive relationships with other employees across the company and with outside regulators and serve as the compliance and privacy ambassador for the company. Privacy Oversight Serve as the primary in-house HIPAA privacy expert, ensuring safety and integrity of protected health information (PHI) across all platforms, services, and operations. Develop, implement, and manage privacy-related policies, training programs, and HIPAA awareness initiatives, including company-wide annual training and attestation processes. Lead and document privacy incident and breach investigations, including coordinating with Legal, regulatory reporting, executive communication, and oversight of incident response efforts. Oversee periodic internal and vendor privacy audits, ensuring optimal privacy practices and industry best practices. Collaborate cross-functionally with Legal, Product, Clinical, and other teams to perform privacy risk assessments, review and maintain consent forms (including patient testimonials), and address privacy risks in business processes and technology Contribute to updates and notices of privacy practices and review use of patient testimonials and patient data for compliance with consent and privacy expectations. Align privacy policies and risk management processes with broader security frameworks (e.g., SOC 2), in partnership with the Director of Information Technology. Contribute to the vendor procurement process by reviewing vendor documentation and checklist from a privacy and compliance perspective. Education & Licensure Requirements: Bachelor's degree in law, Business Administration, Finance, or a related field. A master's degree or professional certification (e.g., Certified Compliance & Ethics Professional - CCEP) is a plus. Other Skills or Qualifications: 5+ years of experience in compliance, legal, or regulatory roles (healthcare, provider practices, or healthcare technology environments are a plus). Familiarity with HIPAA, HITECH, Anti-Kickback Statutes, and other relevant healthcare regulations. Excellent communication and interpersonal skills, with the ability to interact with all levels of staff and management. Strong analytical and problem-solving abilities. Strong attention to detail, organizational skills, and the ability to manage multiple tasks in a fast-paced environment. Proficiency in compliance-related software and tools. Here's what we'd like to offer you: Equal investment and support for our people and patients. A fun and ambitious start-up environment with a culture that takes on important things, takes risks, and learns quickly. The ability to demonstrate creativity, innovation, and conscientiousness, and find joy in working together. A team of highly skilled, incredibly kind, and welcoming employees, every one of whom has something unique to offer. We know that the overall success of our business is a collaborative effort, and we strive to provide ongoing opportunities for our employees to learn and grow, both personally and professionally. Full-time employees are eligible to participate in our benefits package which includes Medical, Dental, Vision Insurance, Paid time off, Short- and Long-Term Disability, and more. Work Environment: The work environment characteristics described here are representative of those encountered while performing the essential function of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. 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 person the essential functions. While performing the duties of this job, the employee is regularly required to sit, stand, talk, visualize, or hear. We are an equal opportunity and affirmative action employer. We embrace diversity and are committed to creating an inclusive environment for all employees. Applicants will be considered for employment without regard to race, religion, gender, gender identity, sexual orientation, national origin, age, disability, or veteran status. Powered by JazzHR gYEWS6wQvl