JUMP TO CONTENT

Document Specialist (Non-Clinical)

  1. United States
2024-111400
  1. Clinical Trial Support
  2. ICON Strategic Solutions
  3. Office Based

About the role

This vacancy has now expired. Please see similar roles below...

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. 

 

The Nonclinical Document Specialist assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.


 

What you will be doing: 

 

  • Within the regulatory document management system:
    • Generates quality and nonclinical basic structures and content for regulatory submissions. 
    • Ensures relevant regulatory-authority compliant document naming conventions are applied to components.
    • Imports and creates documents for regulatory submissions including referenced literature and reference lists
  • Submission document editing, including:
    • Cross reference and update of reference list citations against in-text references
    • Creation of abbreviations list within documents
    • Creating intra-document and inter-document hyperlinks between documents that meet company submission ready standards
    • Formatting, conversion, or retyping of data tables using the Authoring Tool (MS Word, MS Excel)
  • Submission readiness conformance with house-style, sponsor's submission ready standards and regulatory agency requirements:
  • Formats Word documents
  • Performs PDF editing
  • Ensures submission documents are navigable
  • Converts quality submission documents
  • Contributes to the preparation and maintenance of submission document templates.
  • Participates on project teams related to deliverables standards or harmonization or procedures within the team scope.

You are: 

 

  • Bachelor’s degree or equivalent industry-relevant experience
  • Expertise in using Document Management System gained in a pharmaceutical environment, eg, Documentum in order to be able to support and train
  • Experience in understanding nonclinical dossier structures and advanced knowledge of common file formats (eg, Word) and related publishing tools (eg, ISI Toolbox, Adobe Acrobat, eCTDXPress)
  • Knowledge of regulatory authorities’ requirements on electronic submissions in several regions (eg, US, Europe, etc.)
  • Highly developed influencing skills and interactive communication when interacting with people at all levels and within teams
  • Demonstrated ability to set and manage priorities, resources, goals and project initiatives
  • Experience working in cross-functional, global project teams.

 

 

Compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level

 

What ICON can offer you: 

 

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. 

 

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.  

 

Our benefits examples include: 

  • Various annual leave entitlements 
  • A range of health insurance offerings to suit you and your family’s needs 
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead 
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being 
  • Life assurance 
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others 

 

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits 

 

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. 

 

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here 

 

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. 

 

 

List #1

Day in the life

A picture of chemists on a superimposed periodic table
5 reasons why you should consider a career in Clinical Research

Teaser label

Inside ICON

Content type

Blogs

Publish date

01/17/2025

Summary

Five Reasons Why You Should Work at a Contract Research Organization Contract research organisations (CROs) play a pivotal role in advancing medical science, offering career opportunities that are

Teaser label

If you’re seeking a rewarding and fulfilling work environment, a career at a CRO might be the perfect fit.

Read more
Man with headphones on looking at a laptop
Tips to make a lasting impression in a video interview

Teaser label

Career Progression

Content type

Blogs

Publish date

05/10/2024

Summary

Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv

Teaser label

Ace your virtual job interview with these proven video interview tips.

Read more
EPIC Interns
ICONs EPIC Internship Program

Teaser label

Career Progression

Content type

Blogs

Publish date

07/20/2023

Summary

Unlocking your Potential: The Benefits of ICON’s EPIC Internship Program  Internship programs have become a vital stepping stone for students and young professionals seeking to gain practic

Teaser label

Read more about ICON plc's EPIC (Entry-level Professionals in CRO (Contract Research Organization)) internship program.

Read more
View all

Similar jobs at ICON

CTA

Salary

Location

Italy

Department

Clinical Operations Roles

Location

Italy

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech

Reference

2025-116565

Expiry date

01/01/0001

Mattia Carcangiu Read more Shortlist Save this role
Clinical Research Coordinator (Ophthalmology) - Johns Creek, GA

Salary

Location

United States

Department

Clinical Operations Roles

Location

United States

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

As a Clinical Research Coordinator you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. This position is located in John's C

Reference

2025-116506

Expiry date

01/01/0001

Jamie Pruitt

Author

Jamie Pruitt
Read more Shortlist Save this role
SMAII

Salary

Location

Netherlands

Department

Clinical Operations Roles

Location

Netherlands

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us

Reference

2025-116542

Expiry date

01/01/0001

Iris Brouwer

Author

Iris Brouwer
Read more Shortlist Save this role
Clinical Trial Assistant

Salary

Location

Netherlands

Department

Clinical Operations Roles

Location

Netherlands

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

We are looking for CTA based in the Netherlands The Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities from the start up to execution and close o

Reference

2025-116538

Expiry date

01/01/0001

Iris Brouwer

Author

Iris Brouwer
Read more Shortlist Save this role
Business Analyst II (clinical research)

Salary

Location

United States

Department

Clinical Operations Roles

Location

United States

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

As a Business Analyst you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-116335

Expiry date

01/01/0001

Jonathan Holmes Read more Shortlist Save this role
Site Contract Analyst

Salary

Location

Romania

Department

Clinical Operations Roles

Location

Romania

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

As a Site Contract Analyst you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-116453

Expiry date

01/01/0001

Dariusz Sternlicht Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above