Submissions Specialist

工作内容

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.

This role offers the right candidate the opportunity to join a fast growing and developing Global Regulatory Affairs team. The Submissions Specialist manages the activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other central authorities for the assigned country/countries.

Further responsibilities:

• Management of country level submissions associated with ensuring Investigational Product and any other clinical trial supplies can be imported / exported into/from the country the LRAA is responsible for.
• Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
• Management of the country level Informed Consent and any other documentation given to patients through to submission and approval by country level RA and Central IEC as appropriate.
• Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems.
• Perform role of Local Reviewer in the QC process as appropriate.
• Providing consultancy to the client on any country specifics issues if requested.

You are:

A quality focused self-starter with ambition to learn and develop.

Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

• A minimum of bachelor degree in medical management assistant or other paramedical field
• Knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
• The ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
• Strong communication skills and fluency in written and spoken English and Dutch

Even more you are:

Someone who would like to join a dynamic, fast-growing team, in which there is not a typical hierarchical structure, but where everyone can take additional responsibilities next to the operational work, such as being a mentor for new starters, etc.

Someone who is looking for a real team spirit and a team where everyone is valued for what they do.

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.