JUMP TO CONTENT

Sr Administrative Assistant

053370_2

About the role

This vacancy has now expired. Please click here to view live vacancies.

Summary 

To provide comprehensive regulatory operations services for clients in compliance with applicable regulations, the company’s Standard Operating Procedures, and project-specific operational agreements.

 

This role is part of the Regulatory Operations group responsible for publishing, compilation, filing and maintenance of all global regulatory submission types in a timely and accurate manner.  This position may function within a project team and may interact directly with internal staff, the client, and regulatory agencies to manage compilation of regulatory submissions. 


Responsibilities:

Provide support for submissions and other documents by performing necessary tasks including photocopying, scanning and printing, assembly, dispatch and coordinating resources for submissions.

Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities.  This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing, publishing, production (paper and electronic), and archiving (paper and electronic), as applicable.

Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines

Maintain submission components associated with a regulatory submission, paper and/or electronic, as required.  This may include, but is not exclusive to, setting up templates, updating procedures, and project tracking

Assemble electronic and paper Regulatory Submissions and packages for Health Canada, US Food and Drug Administration, the European Medicines Agency and other international regulatory authorities using specialty EDMS/publishing software.

Perform quality review of Regulatory Operations team members work to ensure accuracy.

Participate in submission teams, maintaining necessary liaison between both project leader, and when applicable, with client.

Responsible for managing project workflow throughout the submission process, including prioritizing project objectives, and overseeing progress of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs when required.

Maintain current knowledge of applicable regulations and industry best practices.  Participate in the interpretation of guidelines and impact assessment to current work procedures.  Anticipate Regulatory consequences and advise project teams on publishing issues and strategies.

 Participate in and conduct formal interactions (face-to-face meetings, teleconferences, etc.) with project teams and government agencies in a polite and professional manner.

 Assist in the design and implementation of new processes or initiatives within the department.

 Participate in special projects and carry out assigned activities in support of the Publishing function.

Knowledge/Skills/Attributes

 

·         Community College Diploma or University Degree in Health Sciences or Information Technology / Computer Sciences or equivalent relevant experience and training.

·         Intermediate to advanced working knowledge of MS WORD, Excel, and Adobe Acrobat.

·         Time and resource management skills combined with a strong ability to multi-task.

·         Ability to maintain a high level of accuracy and attention to detail.

·         Excellent communication and interpersonal skills.

·         Knowledge of a variety of computer programs including MS Office, Adobe Acrobat

·         Ability to work collaboratively as part of a team.

·         Time and resource management skills combined with a strong ability to multi-task.

·         Ability to maintain a high level of accuracy and attention to detail.

·         Awareness/knowledge of Health Authority regulations, guidelines, policies pertaining to electronic regulatory standards desirable

·         Awareness/knowledge of eCTD standard desirable

·         Excellent communication and interpersonal skills.

-         Ability to work collaboratively as part of a team

List #1

Day in the life

video job interview
Interviewing at ICON

Teaser label

Inside ICON

Content type

Blogs

Publish date

01/05/2026

Summary

Interviewing at ICON: What to Expect Applying for a new role can feel uncertain, particularly when recruitment processes use digital tools or assessments that may be unfamiliar. At ICON, we want ca

Teaser label

Learn what to expect when interviewing at ICON, and how hiring decisions are always made by people.

Read more
Job application note
Applying to ICON: How Workday’s ATS Works and How to Stand Out

Teaser label

Inside ICON

Content type

Blogs

Publish date

01/05/2026

Summary

What is an Applicant Tracking System (ATS)? An Applicant Tracking System (ATS) is software used by organisations to manage the recruitment process from job posting through to hiring. It acts as a

Teaser label

Learn how ICON uses Workday’s applicant tracking system (ATS), what recruiters see, and how to optimise your application.

Read more
Headshot of male
Leading Through Change: Zhong Yao's Journey at ICON in China

Teaser label

Our People

Content type

Blogs

Publish date

12/10/2025

Summary

Zhong Yao's Journey at ICON Plc in China Zhong Yao's career in clinical research spans over two decades, with leadership roles across major CROs and a commitment to advancing healthcare in China.

Teaser label

From culture to collaboration, Zhong Yao explains how ICON China delivers quality clinical trials, and empowers local talent.

Read more
View all

Similar jobs at ICON

Pharmacovigilance Associate

Salary

Location

Brazil, Sao Paulo

Location

Sao Paulo

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Drug Safety

Job Type

Permanent

Description

We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team. As a Pharmacovigilance Associate at ICON, you will play a vital role in monitoring and ensuring the safety

Reference

JR142262

Expiry date

01/01/0001

Tulio Sanquiz

Author

Tulio Sanquiz
Read more Shortlist Save this role
Clinical Research Coordinator (FT, Łódź)

Salary

Location

Poland, Warsaw

Location

Warsaw

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Research Site Services

Job Type

Permanent

Description

We are currently seeking a Clinical Research Coordinator to join our diverse and dynamic team. As the Clinical Research Coordinator at ICON, you will play a crucial role in supporting project initiati

Reference

JR142388

Expiry date

01/01/0001

Jacek Jaworski Read more Shortlist Save this role
Senior CRA (Phase I Oncology) - TN/KY

Salary

Location

Nashville, TN

Location

Lexington

Nashville (TN)

Knoxville

Bristol

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical

Reference

JR142037

Expiry date

01/01/0001

Jonathan Holmes Read more Shortlist Save this role
Senior Data Scientist, Data Management

Salary

Location

US, Blue Bell (ICON)

Department

Full Service - Symphony Health

Location

Raleigh

Blue Bell

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Engineering

Job Type

Permanent

Description

Symphony Health, part of the ICON plc family, is a team of curious thinkers and intellectual problem solvers driving the healthcare data industry forward. We leverage our large, integrated healthcare

Reference

JR140960

Expiry date

01/01/0001

Michael Hartley Read more Shortlist Save this role
Keuringsarts / Physician Assistant (PA)

Salary

Location

Netherlands, Groningen GRQM

Department

Full Service - Early Clinical and Bioanalytical Solutions

Location

Groningen

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Physician

Job Type

Permanent

Description

Bij ICON maken onze mensen het verschil! We zoeken een keuringsarts of PA die graag een rol wil spelen in geneesmiddelenonderzoek.In deze rol screen je deelnemers, bewaak je de veiligheid en draag je

Reference

JR138174

Expiry date

01/01/0001

Clodagh Finnegan Read more Shortlist Save this role
Senior Statistical Programmer

Salary

Location

India, Bangalore

Location

Bangalore

Chennai

Trivandrum

Bengaluru

Remote Working

Office or Home

Business Area

ICON Strategic Solutions

Job Categories

Clinical Programming

Job Type

Permanent

Description

We are currently seeking a Senior Statistical Programmer I to join our diverse and dynamic team. As a Senior Statistical Programmer I at ICON, you will play a crucial role in analyzing clinical trial

Reference

JR142358

Expiry date

01/01/0001

Swathy Anandan Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above