Global Labelling Lead

ICON plc

10d

About The Position

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. 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.

Requirements

• 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

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior