Security Manager - FDA and Healthcare Data Compliance

Truveta provides unprecedented real-world data and real-time intelligence, powered by a dataset built with and owned by US health systems united in a mission of Saving Lives with Data. Together, we power breakthrough medical discoveries, accelerate regulatory-grade evidence, and improve patient care. Today, Truveta enables research on more than 130 million de-identified patients across the US.  

Achieving Truveta’s ambitious mission requires an incredible team of talented and inspired people with a special combination of health, software and big data experience who share our company values.

This Opportunity 

This Compliance Manager position is an individual contributor role who will report to our Compliance Manager Lead. You will be part of the Compliance team responsible for standing up and maintaining governance over Truveta’s internal controls environment.  We establish compliance programs and a roadmap to achieving and maintaining security and privacy-related certifications and attestations, e.g., ISO 27001, 27018, 27701, Type 1 and Type 2 SOC 2, 21 CFR Part 11 and HITRUST. We are committed to the trust of our health system members and with each other, so please come with your sleeves rolled up, ready to be accountable for business-critical assignments, tight timelines, high quality expectations, and attention to detail.  You will be rewarded as a part of building something that contributes to the mission and knowing your hard work is making a significant impact. 

Responsibilities will include:    

• Managing compliance with the U.S. Food & Drug Administration (FDA) regulations over the use of Real World Data (RWD) and Real World Evidence (RWE) in a health data and analytics environment. 

• Managing compliance with other government regulatory bodies such as the U.S. Department of Health and Human Services’ Office of Civil Rights governing the use of healthcare data 

• Creating, updating, and implementing Truveta policies and procedures 

• Performing risk assessments according to Truveta’s methodology 

• Providing support for audits 

• Assisting control owners and performers 

• Testing controls and identifying gaps requiring remediation 

• Implementing and maintaining compliance automation tools 

• Maintaining comprehensive records of compliance activities and preparing reports for senior management and regulatory bodies as required. 

Key Qualifications   

• Bachelor’s or higher degree in relevant field 

• 5 plus years of experience in healthcare compliance or audit, preferably in a data and analytics setting 

• Experience with FDA regulations 

• Experience with Quality Management Systems (QMS) 

• Strong experience and knowledge of cloud technology and big data analytics 

• Outstanding written and verbal communication and interpersonal abilities 

• Proficiency in productivity tools such as Microsoft Word, Excel, and PowerPoint and the ability to learn and adopt other collaborative tools 

• Ability to work independently and as part of a team 

• Pluses: current or past certification as CISA, CIA, CRISC, CISSP, CIPT, HITRUST CCSFP, or related disciplines; big four experience.