JUMP TO CONTENT

RA Submissions Specialist

  1. Warsaw
2023-102175
  1. Study Start Up
  2. ICON Strategic Solutions

About the role

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

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, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.


ICON, Strategic Solutions are currently recruiting for experienced Regulatory Submissions Specialist or Study Start-Up Associates to join our local Study Start-Up team.

 

This particular role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; a client that values their staff and puts an emphasis on career development.

 

You will be 100% client focused with a prestigious pharmaceutical company.

 

In this role you will:

  • prepare clinical trial submissions for local Regulatory Authorities under the EU-CTD
  • liaise with regulatory authorities and work in close collaboration with the CRAs and the Local Study Team/Local Study Managers to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.
  • actively participate in Local Study Team meetings
  • update CTMS and other systems with data from study sites as per required timelines during the start-up period.
  • follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
  • ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, SOPs and local requirements.
  • provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.

Requirements:

  • BA/BS , preferably in the Life Sciences, or RN
  • Previous experience in submissions to Regulatory Authority in Poland is essential
  • Experience with EU CTD submissions is required
  • Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP
  • Basic understanding of drug development process
  • Good collaboration and interpersonal skills.
  • Excellent attention to details.
  • Good ability to learn and to adapt to work with IT systems

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

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, color, 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.

 

 

#LI-DS1

#LI-Hybrid

List #1

Day in the life

Similar jobs at ICON

Site Activation Partner I

Salary

Location

Brazil

Department

Study Start Up

Location

Brazil

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Study Start Up

Job Type

Permanent

Description

As a Study Start Up Associate/ Site Activation Partner you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative

Reference

2025-120467

Expiry date

01/01/0001

Bruna Duarte

Author

Bruna Duarte
Read more Shortlist Save this role
Clinical Trial Call Center Representative - Entry Level

Salary

Location

US, Salt Lake City (PRA)

Department

Full Service - Early Clinical and Bioanalytical Solutions

Location

Salt Lake City

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Job Type

Permanent

Description

We are currently seeking a Clinical Trial Recruitment Representative to join our diverse and dynamic team at ICON at our Salt Lake City UT site. Location: On-Site Salt Lake City UTJob Type: Full Time

Reference

JR131004

Expiry date

01/01/0001

Kris Costello

Author

Kris Costello
Read more Shortlist Save this role
Program Manager, FSA

Salary

Location

Poland, Warsaw

Location

Sofia

Prague

Dublin

Riga

Warsaw

Lisbon

Belgrade

Bratislava

Remote Working

Home or Office

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Job Type

Permanent

Description

Accountable for driving and accelerating the activation of global investigative sites in line with, or ahead of, the study's contractual timelines, within budgeted resources, with quality output, and

Reference

JR132104

Expiry date

01/01/0001

Magda Kozuszek Read more Shortlist Save this role
Senior Site Partner

Salary

Location

Turkey, Ankara

Location

Ankara

Remote Working

Home or Office

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Job Type

Permanent

Description

Role Summary:Accountable for the expert level independent and proactive co-ordination of all necessary activities required to achieve timely site activations and maintenance tasks for any given site(s

Reference

JR129137

Expiry date

01/01/0001

Magda Kozuszek Read more Shortlist Save this role
Senior Study Support Assistant

Salary

Location

UK, Swansea

Department

Full Service - Development & Commercialisation Solutions

Location

Dublin

Swansea

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Job Type

Permanent

Description

The Senior Study Support Assistant is responsible for assigned project site start-up and qualification activities per study specific requirements. Additionally, the Senior Study Support Assistant will

Reference

JR130731

Expiry date

01/01/0001

James Smith

Author

James Smith
James Smith

Author

James Smith
Read more Shortlist Save this role
Study Support Assistant

Salary

Location

Mexico City

Department

Study Start Up

Location

Mexico City

Business Area

ICON Strategic Solutions

Job Categories

Study Start Up

Job Type

Permanent

Description

As a Study Support Assistant  you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence

Reference

2025-120464

Expiry date

01/01/0001

Rita Villavicencio Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above