Ref #: 31469

Employment type: Permanent - Full-Time

Location: Romania

Posted: 18-Aug-2021


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.

Role Summary:
Oversight and coordination if operational submissions execution for designated CTAs. Operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards timely delivery of globally compliant submission-ready components.

Role Responsibilities

• Drives global submission management strategy and activities for assigned protocols.
• Support and lead global team efforts to ensure high quality components and submissions
• Prepare, review and support the sponsor’s submissions to HA/Regional CTA Hub, in order to obtain necessary authorizations/approvals for the clinical trial conduct
• Liaise with the sponsor’s SSU and Study Management teams regarding essential core documents and local documentation
• Coordination of translations for core documents required for submissions
• Manages the compilation for core document package build, contributing to CTA and authoring documentation as required
• Regulatory CTA manager may act as local country liaison when required
• Escalates, informs and resolves any issues that may impact submission builds of the logistics of global submission delivery to regional and local partners or Health Authorities

• B.S./B.Sc. in Life Sciences
• In-depth understanding and proven experience of CTA and Central Ethics processes in the EMEA/globally
• 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, 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.