Role Description The IRB Regulatory Coordinator supports the day-to-day operations of the Institutional Review Board (IRB) by coordinating regulatory, administrative, and operational activities that ensure compliance with federal regulations, institutional policies, and ethical standards governing human subject research. This position serves as a key resource for investigators, research staff, and IRB members by: - Facilitating regulatory review processes - Supporting committee operations - Maintaining electronic IRB systems - Promoting continuous quality improvement across the research enterprise The IRB Regulatory Coordinator partners with Research Administration, Compliance, investigators, and hospital leadership to support efficient IRB operations while safeguarding the rights and welfare of research participants. Qualifications - Associate of Arts or Associate of Science degree - Bachelor's degree in Business Administration, Health Administration, or a related field preferred Requirements - Minimum one (1) year of experience with federal regulations governing human subjects research and their application in an IRB environment - Minimum one (1) year of experience supporting or coordinating IRB or research compliance processes - Minimum one (1) year of experience utilizing electronic IRB systems and regulatory documentation practices Company Description Recognized as a top place to work in health care, Baptist Health cares for more patients in Northeast Florida than any other provider, ranking as “most preferred” for more than 30 years. We’re Jacksonville's only locally governed, faith-based, not-for-profit health system and provide a full spectrum of preventive and specialty care through 200+ locations and six hospitals. Our centers of excellence include: - Baptist MD Anderson Cancer Center - Baptist Heart Hospital - Baptist Neurological Institute - Wolfson Children's Hospital

Role Description The Regulatory Publishing Manager supports document-level regulatory publishing activities within a global Veeva Vault Publishing environment. This role focuses on preparing submission-ready regulatory documents through advanced Microsoft Word formatting, dynamic linking within Veeva, and compliant PDF generation. This position works within submission documents to ensure technical accuracy, formatting quality, and alignment with global regulatory standards. The role partners closely with document authors and regulatory stakeholders to embed quality into source documents, reduce time-to-file, and improve document reusability. This is an evolving environment requiring a self-starter comfortable working with refining templates, checklists, and processes. - Format complex regulatory documents in Microsoft Word to meet submission-ready standards. - Apply structured formatting, hyperlinks, bookmarks, cross-references, and linking best practices. - Convert Word source files into compliant, high-quality PDFs. - Work within Veeva Vault Publishing to manage document workflows and dynamic linking functionality. - Support report-level publishing (e.g., clinical reports, protocols, periodic reports). - Ensure alignment with global regulatory publishing standards and eCTD requirements. - Partner with document authors and SMEs to build quality into Word source documents early. - Provide guidance on submission-ready formatting standards. - Support refinement of evolving submission checklists and templates. - Manage multiple concurrent document priorities independently. Qualifications - 5–7 years of global regulatory publishing experience. - Strong knowledge of eCTD structure and electronic submission requirements. - Experience with Veeva Vault Publishing (direct experience strongly preferred). - Advanced Microsoft Word formatting expertise. - Experience generating submission-ready PDFs. - Ability to work independently in a developing, non–cookie-cutter environment. - Strong attention to detail and quality mindset. - Effective cross-functional communication skills. Requirements - Bachelor’s degree preferred but not required. - Experience supporting global regulatory submissions required. - Experience working in a system transition or evolving publishing environment preferred. Benefits - Contract Length: Through the end of the year, with the chance to extend. - Pay Range: $65/hr. - $75/hr. - Shift/Hours: Monday - Friday. Remote. EST hours.

Role Description The primary responsibility of the compliance specialist is to assist the Compliance Testing Manager with the daily and periodic monitoring, researching, and review of state and federal compliance requirements, acts, and laws. Is predominantly self-directed, self-motivated and receives occasional direction and oversight from the Compliance Testing Manager. - Partner with the Compliance Testing Manager and other Compliance Specialists in administering the Bank’s testing and monitoring schedule. - Assist in the development of testing and monitoring review scope and objective. - Develop test documents and compile work papers that effectively document the completion of test steps. - Complete testing to assess compliance with federal regulatory requirements. - Prepare reports of testing results that clearly communicate findings including identified exceptions and root cause analysis. - Communicate results of transactional testing to the appropriate business units and assist with corrective actions. - Effectively communicate, assist, and advise applicable business units on various state and federal compliance laws and regulations. - Attend seminars, workshops, and conferences on behalf of Bank to expand Compliance Department’s knowledge of new and updated compliance requirements. - Assist in providing information during regulatory examinations and internal or external audits. Qualifications - Thorough knowledge of applicable laws and regulations; Equal Credit Opportunity Act, Home Mortgage Disclosure, Electronic Funds Transfers, Fair Debt Collection Practices Act, Fair Credit Reporting, Real Estate Settlement Procedures Act, Truth in Lending, Truth in Savings, etc. - Research and analyze federal and state regulatory requirements. - Ability to develop and maintain close working relationships with business units and individuals. - Needs to effectively work with Microsoft Office products and other computer software programs. - Organizing priorities and meeting deadlines. - Problem solving and critical thinking skills. Requirements - One to three years of related bank compliance experience. - Bachelor's degree (B. A.) from four-year college or university. - Knowledge and experience in Consumer Protection Regulations including TILA, RESPA, Fair Lending, FCRA, SCRA, HMDA, CRA, Flood and deposit regulations, Reg E, Truth in Savings, Reserve Requirements, Deposit Insurance. - Familiarity with required loan documentation, including but not limited to consumer, installment, commercial and real estate loans. - Excellent presentation, interpersonal, written and verbal communications skills. Computer and Software Skills - Skilled in operation of a personal computer, including Microsoft Word and Excel. - Prior experience, or ability to learn, RiskExec, Salesforce, Encompass. Equal Opportunity Statement Enterprise Bank & Trust is committed to helping individuals with disabilities participate in the workforce and ensuring equal opportunity to apply and compete for jobs. If you need an accommodation in order to apply for a position at Enterprise Bank & Trust please contact Human Resources at hr@enterprisebank.com. Enterprise Bank & Trust is committed to managing our business and community relationships in ways that positively impact our associates, clients, and the diverse communities where we work and live. We are proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, national origin, sexual orientation, gender identity or protected veteran status and will not be discriminated against on the basis of disability. All employment offers are contingent upon the applicant successfully completing both drug and background check screenings. If you would like more information about your EEO rights as an applicant under the law, please click HERE.

• Serve as the primary compliance authority embedded within the QC laboratory, ensuring that all analytical and quality control operations supporting mRNA and biologics manufacturing are conducted in full accordance with applicable GxP regulations, internal quality standards, and global regulatory expectations. • Act as a strategic compliance partner to QC laboratory leadership, driving a culture of quality and continuous improvement across all QC functions. • Provide expert guidance on regulatory requirements, lead audit readiness initiatives, oversee quality management system activities, and serve as a mentor and subject matter expert (SME) for QC laboratory staff. • Ensure inspection readiness at all times and support the integrity of data generated in support of product release, stability, and method lifecycle activities.