Senior Regulatory Research Manager

 Senior Regulatory Research 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. 

The Opportunity

In this role, you will lead researchers and analysts in performing clinical research and creating the regulatory analytics infrastructure which utilizes Truveta’s data to ensure our data is the highest-quality, most complete, and most usable data for our customers. Your team will be responsible for creating and driving robust research studies that will be evaluated and submitted to clients and regulatory agencies. You will be responsible for the evaluation of data quality, analyses, and scaling our internal processes to apply to broader projects at scale. 

Responsibilities:

• Provide strategic leadership in the clinical and regulatory-focused research that utilizes the Truveta platform
• Serves as the subject matter expert on best practices on RWD data management and regulatory requirements
• Accountable for the strategic growth and continued success of regulatory research team
• Works collaboratively to develop, implement, and maintain the infrastructure necessary to support high-visibility client-facing projects
• Is fastidious and detail-oriented and unafraid to roll up their sleeves and dive directly into the data to better understand how best to achieve their goals
• Loves working in a fast-paced environment with numerous moving parts 
• Is an excellent written and oral communicator ranging from customer-facing scenarios to highly technical internal conversations 
• Is passionate for people management and committed to the growth and well-being of their team  
• Is clinically minded, understanding the nuances of clinical practice and how these nuances manifest in real-world data 

Required Skills:

• Master's degree in Epidemiology or related field of study and 10 years of related epidemiology experience, or a PhD in Epidemiology or related field of study and 6 years of related epidemiology experience. 
• 5+ years of experience in a research context developing and executing statistical analysis plans  
• Experience responding to United States, European Medicines Agency, or other national regulatory agencies regulatory requests relating to risk management planning, design and implementation, and reporting of post-marketing safety studies. 
• Able to lead development of SOWs and SAPs for regulatory and related-regulatory submission 
• Familiarity with Good Pharmacoepidemiology Practices (GPP) and European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) 
• 3+ years of hands-on statistical programming experience with R and/or Python. 
• 3+ years of experience analyzing Electronic Health Record data or other Real World Data sources in healthcare  
• Proven ability to partner and collaborate with clients on their research needs  
• Experience with the peer-review publication process and comfort leading submissions 
• Excellent written and verbal communication skills.  
• Previous experience working in start-up environment  

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 bu