RA Submissions Specialist
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About the role
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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.
- 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.
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