ICON plc
Global Labelling Lead
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Global Labeling Lead
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Position Overview
As a Global Labeling Lead at ICON, you will shape and implement strategic regulatory labelling plans to the development and approval of innovative treatments within Plasma derived therapies.
The Global Regulatory Labeling Lead will play a key role in Global Labeling and works under the direction of the Head of Global Labeling and is:
- Responsible, with supervision for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of labeling
- Managing the preparation of strategic labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans.
- Developing regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information.
- Providing advice on current labeling requirements, templates, tools, and Health Authority issued guidance pertaining to pharmaceutical drug and device.
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You Are
An experienced Labeling professional, keen to take the next step in your career.
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:
- An undergraduate degree in a relevant field of study
- Extensive experience and a proven track record of success in Regulatory Labeling
- Advanced knowledge of the scientific principles of the drug development process
- Advanced, broad knowledge of regulations pertaining to drug product labeling
- Excellent oral and written communication skills
- Excellent project management skills
- Excellent critical thinking skills
- Excellent attention to detail
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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply.
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