Veeva System Administrator - Civica Rx
Petersburg, VA
About the Job
About Civica:
Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.
Who suffers most? Patients.
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”
Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.
More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.
Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.
Learn more about Civica’s plans and progress at www.civicarx.org
Job Description:
The Veeva System Administrator is responsible for the implementation, management, and ongoing maintenance of the Veeva Quality Vaults used at Civica, containing QMS, Quality Docs, and Training.
Essential Duties and Responsibilities:
- The Veeva System Administrator coordinates with business process owners for change control, quality assessment and approval, testing, and deployment.
- Develops and implements ongoing training.
- Creates and maintains user accounts.
- Ensures controls related to approval levels and user access are established and maintained.
- Manages changed static data.
- Manages user inquiries for troubleshooting and resolves issues following appropriate SOPs
- Proactively identifies and works to resolve project and system issues.
- Ensures Veeva Quality Vault conforms to regulatory requirements.
- Oversees and participates in the development of application documentation.
- Ensures system workflows and triggers are developed and maintained as established by business process owners.
- Works in coordination with business stakeholders to develop and prepare reports, metrics, and dashboards.
- Works closely with various business stakeholders to lead and manage business requirements and system solution delivery.
- Manages ongoing maintenance and enhancements (i.e. new releases)
- Drive improvements and efficiencies.
- Supports adding vault capabilities as identified by the business.
Basic Qualifications and Capabilities:
- Bachelor’s Degree in a related field plus 5 years of Quality, Regulatory or System Administrator experience, or equivalent work experience is required.
- Proven experience in leading and deploying a combination of the following: QMS, document management, Electronic Learning Management System
- Experience in a pharmaceutical or any highly regulated environment is preferred.
- Knowledge of Quality Assurance/Quality Control Operations and Regulatory.
- Experience with system design and development starting from business requirements analysis through implementation and support.
- Possess and demonstrate excellent oral and written communication skills, as well as proactive problem-solving, analytical, and multi-tasking skills.
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. Some travel (<10%) may be necessary in the execution of the listed duties.