FDA & Healthcare Data Compliance Manager

FDA & Healthcare Data Compliance Manager

Truveta is the world’s first health provider led data platform with a vision of Saving Lives with Data. Our mission is to enable researchers to find cures faster, empower every clinician to be an expert, and help families make the most informed decisions about their care. Achieving Truveta’s ambitious vision 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.  

Truveta was born in the Pacific Northwest, but we have employees who live across the country.  Our team enjoys the flexibility of a hybrid model and working from anywhere.  In person attendance is required for two weeks during the year for Truveta Planning Weeks.

For overall team productivity, we optimize meeting hours in the pacific time zone. We avoid scheduling recurring meetings that start after 3pm PT, however, ad hoc meetings occur between 8am-6pm Pacific time.

Who We Need  

Truveta is rapidly building a talented and diverse team to tackle complex health and technical challenges. Beyond core capabilities, we are seeking problem solvers, passionate and collaborative teammates, and those willing to roll up their sleeves while making a difference. If you are interested in the opportunity to pursue purposeful work, join a mission-driven team, and build a rewarding career while having fun, Truveta may be the perfect fit for you  

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.

 Key Responsibilities

• 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.

Requirements

• 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.

Why Truveta?    

Be a part of building something special. Now is the perfect time to join Truveta. We have strong, established leadership with decades of success. We are well-funded. We are building a culture that prioritizes people and their passions across personal, professional and everything in between. Join us as we build an amazing company together.    

We Offer:

• Interesting and meaningful work for every career stage
• Great benefits package
• Comprehensive benefits with strong medical, dental and vision insurance plans
• 401K plan
• Professional development & training opportunities for continuous learning
• Work/life autonomy via flexible work hours and flexible paid time off
• Generous parental leave
• Regular team activities (virtual and in-person as soon as we are able)
• The base pay for this position is $126,000 to $166,000. The pay range reflects the minimum and maximum target. Pay is based on several factors including location and may vary depending on job-related knowledge, skills, and experience. Certain roles are eligible for additional compensation such as incentive pay and stock options.

If you are based in California, we encourage you to read this important information for California residents linked here.

Truveta is committed to creating a diverse, inclusive, and empowering workplace. We believe that having employees, interns, and contractors with diverse backgrounds enables Truveta to better meet our mission and serve patients and health communities around the world. We recognize that opportunities in technology historically excluded and continue to disproportionately exclude Black and Indigenous people, people of color, people from working class backgrounds, people with disabilities, and LGBTQIA+ people. We strongly encourage individuals with these identities to apply even if you don’t meet all of the requirements.