Experienced regulatory and technical writing professional with 20+ years of expertise in document development, review, and compliance. Proven track record in writing, editing, and formatting complex regulatory documents, policies, and reports for government and healthcare organizations. Trained in eCTD format and document management systems with demonstrated ability to support multidisciplinary teams and meet critical regulatory deadlines.
- Write, edit, and review complex regulatory documents, policies, annual reports, and master files in both Army and Defense Health Agency formats, ensuring compliance with federal regulations and formatting standards
- Provide subject matter expertise on document development to integrated product teams and working groups, advising on writing activities, document review processes, and regulatory compliance issues
- Efficiently apply appropriate formats dependent upon document intent, including government forms, policies, reports, and regulatory submissions
- Conduct comprehensive document reviews for accuracy, legal sufficiency, and regulatory compliance
- Serve as principal advisor on public disclosure of information and regulatory document requirements
- Collaborate with cross-functional teams across multiple time zones, attending meetings with integrated product teams and external stakeholders
- Track and manage multiple writing projects simultaneously, ensuring internal and regulatory deadlines are met
- Provide routine reports and updates to leadership on document development activities and project status
- Assist with project management tasks and proactively identify operational inefficiencies to suggest process improvements
- Serve as designated authority to grant or deny requests submitted pursuant to FOIA/Privacy Act regulations
- Formulate and implement policy as it relates to FOIA/PA compliance and regulatory requirements
- Prepare documentation for complex litigation and provide technical expertise to department attorneys
- Evaluate FOIA/PA request responses for accuracy, legal sufficiency, and timeliness
- Confer and negotiate with administrative personnel, private sector, and governmental agencies on regulatory and policy questions
- Manage complex executive calendars and coordinate logistics for senior leadership
- Handle confidential correspondence and communications with discretion and professionalism
- Maintain digital filing systems, SharePoint administration, and serve as Headquarters Records Management Liaison
- Conduct research and synthesize data to support executive decision-making
- Developed and executed comprehensive written materials including direct mail campaigns, newsletters, annual reports, and stewardship communications
- Created measurement tools and evaluation frameworks for program effectiveness
- Prepared written and printed materials for development, public relations, and program implementation
- Coordinated production and content of organizational promotional materials, ensuring consistent messaging and compliance with nonprofit regulations
- Tracked development projects and goals, defining timelines and deliverables for multiple concurrent initiatives
- Maintained relationships with Board of Directors and coordinated board meeting materials and presentations
- Managed database systems for donor tracking, relationship management, and comprehensive reporting
- Provided regular gift, revenue, and event reports to executive leadership and committees
- Managed comprehensive donor database system (Raiser’s Edge) including data entry, reporting, and analysis
- Wrote and formatted direct mail campaigns, newsletters, and annual reports with subject-matter expertise
- Developed and maintained communication matrices and solicitation strategies for fiscal year planning
- Created annual budget goals and performance metrics with detailed tracking and reporting
- Produced donor communications and correspondence ensuring compliance with nonprofit regulations
- Developed acknowledgment systems and stewardship reports meeting legal and ethical requirements
- Promoted organizational mission and values through strategic written communications
- Managed portfolio of 26 clients including regulatory compliance organizations (501(c)(3) entities)
- Developed and maintained client account metrics and standard communication protocols
- Managed direct mail processes from initial processing through final acknowledgments
- Ensured quality control and compliance with client-specific regulatory requirements
- Resolved complex issues and conflicts while maintaining regulatory compliance standards