Technical Writer at Florence Healthcare (Atlanta, GA)
What We Do:
Florence (florencehc.com) software reduces the time it takes to deliver medical cures to those who need them. Our industry-leading software is used to streamline clinical trials at over 10,000 research sites, sponsors, and CROs across 44 countries.
Florence was recognized as the 8th Best Small Workplace to Work in Atlanta in 2022 by the Atlanta Journal Constitution and also received the “New Ideas Award.” We were also honored as the Biggest Impact Company, a Top 10 Innovative Company in Georgia by the Technology Association of Georgia in 2021, and most recently No. 31 on the Fortune list of Best Small Workplaces 2021.
What You’ll Bring to The Team:
The Florence Compliance Team is looking for a technical writer who is passionate about clinical trials to advance cures. To be successful, you must be comfortable with the software development life cycle (SDLC), compliance nuances, defragmenting documentation, and challenging the status quo in a regulated yet continuously evolving and innovative environment. This role serves as Florence’s policy and procedural guru and technical scribe during audits. As part of this role, you will collaborate with all departments to ensure our documentation is audit-ready, reflecting our current processes with an inventory of available evidence to demonstrate compliance.
- Policies, Procedures, and Tools: Prepare new policies, procedures, and tools in partnership with SMEs and industry consultants to better align existing documentation with software and clinical research best practices
- Validation Documentation Mapping: Improve existing software validation deliverables and map to previous documentation (e.g., User Requirements Specifications, Validation Plan, Risk Assessment, Test Protocols/Reports, Validation Summary Report, etc.)
- Global Regulatory Documentation: Collaborate with our Global Regulatory Specialist to build a library of regulatory interpretations for US FDA 21 CFR Part 11, EU EMA, and UK MHRA requirements that outline the shared responsibilities between Florence and its customers (Sponsors, CROs, Sites)
- Global Data Privacy Documentation: Collaborate with our data protection teams to refine templates and technical documentation to ensure compliance with global privacy requirements (e.g., EU GDPR, UK GDPR, US CCPA, etc.)
- Audit Evidence Inventory: Develop an inventory of Florence’s audit evidence that maps to its regulatory requirements and controls
- Documentation Automation: Explore manual and/or redundant documentation workflows suitable for automation with software tools
- Training: Share tips and training ideas across the company to improve internal documentation practices
- Improvement Projects: Collaborate with the Florence Compliance Team on various projects to improve and innovate technical documentation for audit readiness
- Audit Support: Support the Junior Compliance Officer during audits by recording meeting minutes (e.g., questions, comments, action items), noting general observations, and providing feedback during audit debrief sessions
An Ideal Candidate has:
- 3+ years of relevant experience in software validation and change management as a technical writer, preferably in a regulated industry (e.g., pharmaceutical, medical device)
- Fluency in the software development life cycle (SDLC), quality management systems (QMS), and classic validation documentation
- Audit-minded and working knowledge of FDA Software Validation Guidelines and Good Documentation Practices (GDP)
- Interested in continuous improvement and ways to minimize redundancy
- Comfortable working independently, challenging the status quo, and meeting deadlines
- Plus: Awareness of security (SOC and ISO) and privacy (GDPR, HIPAA)
What’s in it for you?
- Work with the best: The Florence team is composed of document management, clinical trials, and software security experts as well as doctors and Ironman triathletes. Get on board, learn from and work with the best.
- Make the leap: Join our high-output culture to create innovative, modern, and purposeful software solutions.
- Do well: We offer a competitive compensation package, medical and dental insurance, and office space in the heart of the city.
Florence Healthcare supports workplace diversity and does not discriminate on the basis of race, color, religion, gender identity or expression, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, physical disability, or any other protected class.