Emmes Group: Building a better future for us all. Overview Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Founded more than 47 years ago, Emmes has become one of the primary clinical research providers to the U.S. government before expanding into public‑private partnerships and commercial biopharma. We have built industry‑leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. Our mission is to have a direct impact on patients’ lives and to build a collaborative, performance‑driven culture. Job Summary The Controlled Documents Specialist is responsible for managing the controlled document lifecycle within the Veeva Quality platform, ensuring compliance with regulatory requirements, internal processes, and quality management standards. Responsibilities Manage the lifecycle of controlled documents in Veeva, including creation, review, approval, issuance, periodic review, and archival. Ensure controlled documents comply with applicable regulatory requirements and internal standards. Route documents for review and approval, ensuring timely completion and escalating as needed. Support stakeholders through document creation, review, and revision. Assist with inspection and audit readiness by keeping controlled documents organized, accurate, and accessible. Maintain accurate metadata and document classification within Veeva. Partner with the system administrator and vendor to support system enhancements and configuration updates. Develop SOPs, quick reference guides, and training materials related to document management. Qualifications Bachelor’s degree in Life Sciences or a related scientific field and 1–3 years of experience working in a regulated environment. 1–3 years of experience using electronic document management systems such as Veeva (Preferred). 1–3 years of experience supporting audits and inspections (Preferred). Understanding of controlled documents and QMS. Attention to detail. Analytical and critical thinking. Written and verbal communication. Ability to prioritize critical tasks and provide a high level of responsiveness and timely service. Ability to manage stakeholders and maintain collaborative relationships in a cross‑functional, global environment. Microsoft Office proficiency. #J-18808-Ljbffr