Veeva System Manager
Company: Civica Rx
Posted on: March 20, 2023
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.--
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.--
Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.
Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."--Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.
To find out more about how Civica's innovative model is directly impacting patient care, click--here--to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click--here--to read an article in BioSpace.
The Veeva System Manager will join the Civica, Inc. ("Civica") team in supplying essential generic and biosimilar quality medicines in the United States by bringing their knowledge and experience to serve patients and pursue excellence in quality and compliance.
The Veeva Administrator supports Civica in ensuring the Veeva Vault Applications are maintained in a compliant manner.-- Responsibilities encompass administration of Civica's Veeva Vault Regulatory Information Management, document, training, Quality Management and Laboratory Information Management systems.--
Essential Duties and Responsibilities
Serves as the Veeva Business Administrator responsible for the implementation, management, and ongoing maintenance of the Veeva Vault, including document, training, QMS, LIMS and RIMs.
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.
Proactively identifies and works to resolve project and system issues.
Ensures Veeva Vault conforms to regulatory requirements.
Oversees and participate 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.
Supports ongoing maintenance and enhancements as required.
Assesses changes to the system (e.g. new releases) for business and training impact.
Drive improvements and efficiencies.
Minimum Qualifications (Knowledge, Skills, and Abilities)
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 or Regulatory Information 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.
Possess ability to work within a team-based environment while proactively forging positive relationships across all levels of management, departments, supplier.
Project Management, Operational Excellence, and/or Lead/Six Sigma experience preferred.
Strong attention to detail and analytical thinking.
Quality Systems Experience in a CGMP environment
Excellent written/oral communication skills and experience with advanced features of Microsoft Word, including templates, styles and macros is required.
Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
Keywords: Civica Rx, Richmond , Veeva System Manager, Executive , Petersburg, Virginia
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