Global Labelling Lead

ICON; Reading; On-site; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Various annual leave entitlements

Health insurance offerings

Retirement planning offerings

Employee assistance programme

Job summary

ICON plc is a world-leading healthcare intelligence and clinical research organization seeking a Global Labelling Lead to shape and implement strategic regulatory labeling plans for Plasma derived therapies. The role reports to the Head of Global Labeling and focuses on global labeling strategy development and implementation across development to approval stages.

You will collaborate with Clinical, Pharmacovigilance, Legal, Scientific, and Commercial teams, providing regulatory labeling

Qualifications

• Undergraduate degree in a relevant field.
• Extensive experience and proven track record in Regulatory Labeling.
• Advanced knowledge of the scientific principles of the drug development process.
• Advanced 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.

Responsibilities

• Provide regulatory expertise, strategic insight, and guidance to internal stakeholders to ensure successful development and maintenance of labeling.
• Manage the preparation of strategic labeling input in the implementation of regulatory strategies and liaise with regulatory team members in evolving submission and negotiation plans.
• Develop regulatory labeling strategies for implementation of new and revised prescribing information and packaging.
• Provide advice on current labeling requirements, templates, tools, and Health Authority guidance pertaining to pharmaceutical drug and device labeling.

Skills

Regulatory labeling

Cross-functional collaboration

Project management

Attention to detail

Communication skills

Education

Bachelor's degree

Job description

Global Labeling Lead

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Global Labelling Lead at ICON -you will shape and implement strategic regulatory labelling plans to the development and approval of innovative treatments within Plasma derived therapies

Position overview:

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

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

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here