Ref #: 34446

Employment type: Permanent - Full-Time

Location: Poland

Posted: 22-Dec-2021

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, 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.

Currently for our Client Top Pharmaceutical Company, we look for experienced candidates from start- up department. We has been asked to build a Senior Start- up Specialist embedded solution for our Client Top Pharmaceutical company. Suitable candidates need to have an experience in managing applications for study approvals to the country Health Authority and also central ethics committee. This is due to the changing process in the way European Union trials will be conducted in future. Currently in some European countries, study start up teams submit central and local ethics committee applications within each country while a regulatory team submits to the country health authority. Our Client is looking for people who can do both. This office or home-based role (any location in Poland).



Requirements:
-At least 5 years of experience in both regulatory approval submissions and central Ethics Committee submissions and an understanding of the requirements of the new process.
-Ability to complete regulatory submissions for regulatory approval through the new EU CTR implementation readiness process.
-Strong candidates at managing escalations, responding to governmental agencies and driving the submissions process.
-European understanding and ability to liaise with internal DOCS/ICON local teams to understand local requirements across all European countries.
-Strong leadership and program management skill set as well as ability to meet tight timelines for submissions.
-Ability to communicate clearly and drive requirements to achieve approvals.
-Strong leadership and program management skill set as well as ability to meet tight timelines for submissions.
-Ability to communicate clearly and drive requirements to achieve approvals.
-Fluent English

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 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 through the form below.

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