Job Description

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-/)

Intro to Civica

https://vimeo.com/646267406

Position Summary

The Training Development and Document Control Associate will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica's new fill finish facility dedicated to the manufacture and supply of essential generic and biosimilar insulin sterile injectable medications.

Responsibilities of the position include establishing and maintaining quality and compliance processes associated with training and development to ensure requirements for Good Manufacturing Practices (GMPs), are being met from the onset of building and qualifying the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

Responsibilities also include but are not limited to ensuring documents are maintained and controlled, managing the document change control process and aid other personnel in utilizing the document control system.

Essential Duties and Responsibilities

• Design, develop and coordinate training program needs.
• Develop and/or review and maintain site curriculums and training requirements in the Veeva Electronic Learning Management System (EDMS).
• Act as a subject matter expert for the Veeva EDMS.
• Ensure that all training requirements and curriculum is reviewed within required intervals.
• Ensure all GMP documentation is maintained and controlled per company procedures.
• Author procedural documents related to area of responsibility.
• Monitor, track, and trend training.
• Act as document control to route procedural documents in the Veeva EDMS to ensure accuracy, completeness, and alignment with procedures
• Review new and revised procedures, ensuring document changes are implemented into Petersburg procedures.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor's degree with a minimum of 3 years training coordinator and document control experience.
• Strong project management, organization, and execution skills with ability to managing multiple projects and priorities.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Ability to work autonomously and within established guidelines, procedures, and practices; can learn by doing.
• Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills and share knowledge with others.

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