Title: Compliance & Audit Specialist Location: Telegraph Rd, Southfield, MI 48034, USA United States Work Type: Hybrid Job ID: 6840 Job Description: What you'll do… This position will be responsible for conducting routine office compliance reviews and effectively communicating compliance findings with the team. The Compliance & Audit Specialist will assist in reviewing, researching, and updating GEDC's Compliance Program and review, analyze and follow up with offices regarding monthly MESA lab spore testing compliance. This role will also collaborate with the Compliance Officer on compliance training topics and communicate those topics to GEDC employees. This position requires a strong focus on compliance auditing, working closely with regional leadership and office teams to review compliance criteria, identify deficiencies, and ensure corrective actions are completed in a timely manner. The role will also maintain vendor relationships related to compliance programs and leverage a variety of software platforms to track, monitor, and report on compliance activities. This position is located at our corporate office in Southfield, MI and has a hybrid schedule of Monday, Tuesday and Thursday in office and Wednesday/Friday remote. What you'll bring to the team… Assist in continually reviewing, researching, and updating Great Expressions Dental Center's Compliance Program based on local, state, and federal governing agencies. Conduct routine PACT tours and office compliance reviews, ensuring adherence to local, state, and federal regulations, including infection control standards, waste management protocols, required postings, and other regulatory requirements. Effectively communicate office compliance review findings to the office team, Clinical Partner, Chief Clinical Officer, Chief Operations Officer, Vice President of Operations, and Area Operations Manager. Provide a clear understanding of compliance deficiencies and provide detailed instructions to correct non-compliant areas in a timely fashion. Effectively follow up with offices on non-compliant items to ensure all areas are brought into compliance and corrective actions are completed. Review, analyze, and follow up with offices regarding monthly MESA Lab spore testing compliance percentages, ensuring weekly spore testing is conducted and compliance percentages reflect 90% or higher. Monitor and support compliance initiatives related to dental unit water line monitoring, infection control oversight, and other clinical compliance protocols. Assist in tracking and monitoring compliance requirements including expiring credentials (e.g., sedation permits), prescription standards, and sedation usage exceptions. Support regulatory reporting requirements including Solmetex amalgam separator reporting and waste compliance documentation. Assist leadership during insurance company onsite reviews or external audits, helping gather documentation, communicate findings, and support compliance responses. Maintain strong working relationships with compliance vendors and partners while utilizing multiple software systems and reporting tools to track compliance metrics and generate reports. Provide training on compliance topics to office teams and all levels of management, effectively answering questions and providing ongoing support. Successfully affiliate new offices with regard to Great Expression's Compliance Program, ensuring all compliance items are implemented and training is completed. Medical or dental coding experience preferred. Other tasks as requested by the direct Manager. What we require you have… Proven track record of developing highly productive working relationships. Strong computer skills including Microsoft Office and various compliance tracking and reporting systems. Superior customer service skills and a successful record of relationship management. Strong presentation skills to speak and teach groups of peers. Excellent written and interpersonal communication and relationship development skills. Ability to work independently and professionally in a fast-paced environment. Ability to learn quickly and adapt rapidly to change. Ability to handle highly sensitive and confidential information in a manner that inspires confidence and trust. Successful record of managing multiple tasks requiring a high level of detail orientation, organization, time management, and follow-up. Ability to travel up to 10-15% as needed. Education & Experience… 2-3 years of experience in a professional office environment. Dental clinical or dental compliance experience preferred. Experience supporting audit processes, compliance monitoring, or regulatory programs is strongly preferred. About GEDC… Since 1982, Great Expressions has been at the forefront of dental innovation, setting the standard for exceptional care and unforgettable patient experiences. Now, we're entering a new era of transformation, and we want you to be a part of it. Our recently appointed leadership team brings over a century of collective dental expertise and is backed by dynamic investment support to pave the way for groundbreaking changes. We're channeling our resources and energy into revolutionizing our technology platform, expanding service offerings, and creating a personalized patient experience that goes beyond the expected. At Great Expressions, we're not just transforming dentistry; we're investing in the growth and development of our team. Join us and be a part of a career that blends innovation and professionalism, where your contribution shapes the future of dental excellence.

Title : Regulatory Strategy Director Location: Boston United States Job Description: Job Description General Summary: The Regulatory Strategy Director will be responsible for the development and implementation of innovative global/regional regulatory strategies for assigned projects within the Vertex portfolio. This position will play a major role in shaping cohesive regulatory strategy for assigned program(s) and ensuring effective integration of broad regulatory ideas/tactics supporting program strategy. This roles assignments may be global, regional or local depending on the position and assigned region. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy. Key Duties and Responsibilities: - Leads the development of regulatory strategy for assigned projects/regions in development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy Documents - Represents GRA on core development functional teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy - Addresses complex issues, providing innovative regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams, GRA functional team and GRA leadership - Anticipates global regulatory changes and develops proactive strategy accordingly - Shapes the regulatory strategy for regulatory submission documents and Health Authority communications - Counsels and advises GRA leadership on status of global Regulatory Affairs strategies and tactics, procedures and practices - Ensures the global regulatory strategy for a given project is consistent with the business objectives and is compliant with current regulations and guidance - Manages project plans and timelines to ensure all projects are appropriately prioritized and key goals are met on time - Contributes to the continuous improvement of existing department processes and strategies, providing recommendations in area of expertise - Provides regulatory leadership to the GRA functional team(s) or projects with moderate resource requirements or complexity Knowledge and Skills: - Experienced in Regulatory Affairs strategy in assigned geographic region, including direct interactions with a variety of stakeholders - Advanced technical skill in regulatory affairs science including knowledge of regulatory frameworks and external environments. Advanced knowledge of global/regional/local regulatory legislation, laws, procedure and guidance for pharmaceutical development of medicines for human use. - Proficient knowledge of the research and development, preclinical and clinical requirements related to drug development, registration, and maintenance of human pharmaceuticals - Proficiency in analyzing and interpreting data, protocols, safety reporting, labeling and other activities related to the phases of drug development for assigned products. - Advanced skill in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, guiding development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development, and in leading productive health authority interactions, including well organized preparation of cross functional teams. - Actively uses expertise to develop others by providing coaching, guidance and mentoring. - A strong collaborative partner with cross functional colleagues with the ability to build consensus through the ability to present a clear and compelling case for ideas - Demonstrates excellent communication skills with ability to impact and influence the decisions of a team Education and Experience: - Bachelor's degree in Biology, Chemistry, or other related discipline - Typically requires 10 years of relevant pharmaceutical or biotech industry experience within regulatory affairs, or the equivalent combination of education and experience #LI-TC1 #LI-Hybrid Pay Range: $196,800 - $295,200 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: - Hybrid: work remotely up to two days per week; or select - On-Site: work five days per week on-site with ad hoc flexibility. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

• Maintain hardened baselines and secure configurations across systems and environments, mapped to policy and control requirements. • Proactively monitor for issues, investigate anomalies, and help drive timely remediation, with strong documentation and traceability. • Produce high-quality control documentation and evidence that stand up to internal audit, external audit, and client scrutiny. • Collaborate effectively with technical and non-technical stakeholders to embed security and compliance expectations into day-to-day operations. • Support execution of compliance and security risk assessments by gathering inputs from control owners, documenting risks, and tracking agreed actions. • Help design and execute control testing plans for key information security and compliance controls (e.g., access reviews, configuration baselines, logging and monitoring), documenting results and exceptions. • Maintain and refine control inventories, risk registers, and metrics/KRIs for information security and compliance, partnering with the Information Security Manager and Compliance to ensure data quality and timely updates. • Assist in evaluating the impact of new regulations, client obligations, and internal policies on existing controls, and help translate requirements into practical control changes. • Prepare and maintain control evidence (e.g., screenshots, configuration exports, reports, tickets) that demonstrate effective operation of information security and compliance controls for internal and external audits. • Partner with Compliance, Legal, and Information Security leadership to support SOC 2, ISO 27001, and related certification activities, including evidence collection, sample selection, and responses to auditor questions. • Coordinate and contribute to client security and compliance questionnaires, RFPs, and on-site/virtual reviews by providing accurate, timely information on controls, hardening standards, and governance processes. • Help organize and track findings and remediation actions arising from audits, certification reviews, and client / regulatory inquiries, ensuring owners, timelines, and status are clearly documented. • Ensure that day-to-day security and compliance practices align with written policies by reviewing procedures, identifying gaps, and proposing pragmatic updates. • Support the Information Security Manager and Compliance in reviewing, updating, and socializing policies, standards, and procedures, including mapping controls to specific requirements and frameworks. • Assist with access control and entitlement governance, including periodic user access reviews, privileged account checks, and validation of joiner/mover/leaver activities against policy and client expectations. • Help document and refine standard operating procedures (SOPs) for recurring controls (e.g., monitoring, evidence collection, configuration reviews, access reviews), ensuring they are clear, consistent, and audit-ready. • Operate day-to-day security monitoring processes, including review of alerts, logs, and dashboards for suspicious activity, misconfigurations, and policy exceptions, ensuring that events are handled in line with documented procedures. • Conduct initial triage and investigation of security and control-related events; document findings, classify impact and risk, and escalate to the Information Security Manager or other stakeholders as appropriate. • Support ongoing vulnerability, patching, and configuration management efforts by validating remediation status, tracking exceptions against policy and risk tolerance, and helping prioritize issues based on business and client impact. • Work closely with Information Security, Compliance, Legal, Infrastructure/Operations, Engineering, and Client-facing teams to clarify security and compliance requirements and ensure shared understanding of control expectations. • Participate in root-cause analysis and remediation planning for security findings, audit issues, client concerns, and control failures; help ensure corrective actions are risk-appropriate and sustainable. • Identify opportunities to streamline and automate compliance and security processes to improve consistency, coverage, and efficiency. • Contribute to training and awareness efforts by providing practical input on technical control topics for relevant audiences.

• Provide governance and oversight of the organization’s Integrated Management System (IMS) • Monitor conformance of information security and quality management processes to applicable ISO requirements • Maintain management system documentation, including policies, procedures, Statements of Applicability, risk registers, and governance records • Plan, coordinate, and conduct internal ISO and compliance audits • Monitor compliance performance through audits, assessments, and reviews, and report results to leadership • Coordinate recurring risk assessments related to information systems and business processes