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Non-Clinical Document Specialist Reading, England

ICON

Full Time Reading, England 32895 - 48396 GBP ANNUAL Today

Job description

UK-based Non-clinical Document Specialist (Home based, United Kingdom)

You will be partnering with a well-known global pharmaceutical company with a strong portfolio in cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation medicines.

You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.

Here in the ICON Strategic Solutions team, we are in an established partnership with a primary multinational pharmaceutical and biotechnology company to supply a permanent, full-time, UK-based Non-clinical Document Specialist co-ordinating regulatory activities.

This is a fully home-based role.

As a Documentation Specialist, you’ll work as a member of the Nonclinical Submission group with accountability for the technical quality and delivery of all nonclinical submissions.

You will build nonclinical regulatory submissions for clinical trial and marketing applications in accordance with current standards and processes using agreed upon tools, and will manage compliance in the Regulatory Document Management system.

Of particular interest are candidates with experience working within a document management position within commercial clinical research in the UK.

Those with good project management skills who are able to confidently communicate with internal and external stakeholders would be ideal.

Bachelor’s degree or equivalent industry-relevant experience
Knowledge of regulatory authorities’ requirements on electronic submissions in several regions (eg, US, Europe, etc.)
1-2 years' experience in using Document Management Systems gained in a pharmaceutical environment
Familiarity with, and the application of, appropriate regulatory principles and guidelines and the passion to work within and contribute to the subject area of non-clinical work within the organisation.

Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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