[Hiring] Controlled Documents Specialist @Emmes Group

Role Description

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.

• 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 escalation as needed.
• Support stakeholders through document creation, review, and revision.
• Support inspection and audit readiness by ensuring controlled documents are organized, accurate, and accessible.
• Maintain accurate metadata and document classification within Veeva.
• Partner with 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 experience working in a regulated environment.
• 1-3 years experience using electronic document management systems such as Veeva (Preferred).
• 1-3 years 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 effectively manage stakeholders and maintain collaborative relationships in a cross-functional, global environment.
• Microsoft Office proficiency.

Company Description

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!