Veeva System Manager
Company: Civica Rx
Location: Petersburg
Posted on: March 20, 2023
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Job Description:
About Civica
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.
(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)
Position Summary
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.
PI208474340
Keywords: Civica Rx, Richmond , Veeva System Manager, Executive , Petersburg, Virginia
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