Key Facts

Remote From:

Colorado (USA)

Full time

English

Hard Skills

Veeva Regulatory Compliance Metadata Management Document Classification Online Communication Project Collaboration

Other Skills

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Detail Oriented
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Analytical Thinking
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Critical Thinking
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Non-Verbal Communication
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Time Management

Roles & Responsibilities

Bachelor’s degree in Life Sciences or a related scientific field
1-3 years experience working in a regulated environment
1-3 years experience using electronic document management systems such as Veeva
Understanding of controlled documents and QMS

Requirements:

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 inspection and audit readiness by ensuring controlled documents are organized, accurate, and accessible

Emmes

Research

About Emmes

For over 40 years, our team of 1,000+ experienced professionals have provided the full range of Contract Research Organization expertise necessary to conduct clinical research with a firm scientific basis that is fully compliant with national and international regulatory guidelines. With offices throughout the US, Europe, Canada, and India, Emmes supports the advancement of global public health and biopharmaceutical innovation through disciplined science, rigorous research, fact-based decision-making, and operational excellence. Emmes possesses knowledge across a broad range of therapeutic areas, with specializations in Vaccines and Infectious Diseases, Ophthalmology, Immunology and Neuroscience. From comprehensive support of pandemic research to groundbreaking work in cell and gene therapy across the globe, Emmes has collaborated on clinical research across a wide array of disease states in over 75 nations. As a strategic collaborator with applied talent in over 2,000 clinical trials and contributions to over 2,500 publications that advance the understanding of medicine and public health, Emmes is committed to expanding the services offered to best meet the changing needs of clients and studies. Ongoing investments in global clinical research capabilities, innovative data management platforms, biostatistics/bioinformatics expertise, and people have enabled Emmes to provide a multi-faceted approach to help you meet your research objectives. Emmes is a diverse, inclusive, innovative CRO that values integrity, agility, passion for excellence, collaborative partnerships, and intellectual curiosity.

Company type: Large

Industry: Research

Founded: 2018

Company size: 1001 - 5000

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Job description

Overview:

Controlled Documents Specialist

LATAM Remote

Emmes Group: Building a better future for us all.

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!

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 escalation asneeded.
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