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Responsibilities:
- Assist the Regulatory Operations Lead in the preparation of regulatory submission documents.
- Work with Regulatory Operations Lead to analyze and develop processes that support business needs using the Veeva Vault RIM suite.
- Partner with Regulatory Affairs and MLR teams to ensure Promotional Review Committee (PRC) approved materials are finalized.
Qualifications:
- Bachelor’s degree and 5+ years of experience in Regulatory Operations with specialized skills in electronic submissions.
- Relevant experience with electronic document management and publishing systems.
- Demonstrate flexibility, patience, and good verbal, written, and interpersonal communication skills.
Vera Therapeutics
Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.