Job Description

Description

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

Who are you?

You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Director, Regulatory Labeling, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you're more than an employee number. A place you love working.

We are looking for a STRONG Director, Regulatory Labeling to manage a team of regulatory professionals, cultivate client relationships and handle business development activities.

Still here? Good. Because if this is you, we'd really like to meet you.

What will you be doing?

As a Director, Regulatory Labeling, you will provide leadership, people management and tactical input on the planning and execution of labeling initiative.

Primary Responsibilities:

Provides labeling expertise, leadership and guidance to team as well as internal and external (client) stakeholders for successful development of core labeling documents, i.e., Company Core Data Sheets (CCDSs), Master Labels, regional/local labeling, where applicable. May provide service as an independent expert or offer labeling consultancy for internal and/or external clients.

Develops and manages regulatory labeling function. Formulates strategies for the submission and implementation of new and revised prescribing information, patient information and packaging. Provides expert advice on current labeling requirements, industry trends, templates, tools, systems; interprets scientific, medical and regulatory regulations and guidance documents.

Builds and maintains strong collaborative relationships with key internal and external (client) stakeholders, including Global Regulatory leadership team, Safety, Quality, Commercial, Medical Affairs, Advertising & Promotion, Global Development, Legal,

Manufacturing, Supply Chain and other functions key to the success of product development and commercialization.

Implements internal or client procedures, processes or programs that result in continuous improvements for labeling activities and business requirements.

Maintains effective teams by recruiting, selecting, orienting, training, and coaching employees; ensures a safe, secure and compliant work environment; provides employees with professional development and growth opportunities.

Achieves staff results by communicating job expectations; planning, monitoring and appraising job results; coaching, counseling and disciplining employees; developing, coordinating and enforcing systems, policies, procedures and productivity standards.

Leads and supports business development efforts and opportunities by providing regulatory labeling input.

In addition, the Director, Regulatory Labeling:

Sets functional goals which contribute to department's vision and long range planning.

Provides line management to direct reports, including training, performance management, professional development and coaching.

Significantly contributes to establishing budgets, schedules, work plans and KPIs.

Makes decisions on administrative and operational matters and ensures the labeling team effectively achieves its objectives.

Sets operational strategies for improving labeling systems/ processes

Promotes partnerships with project/program teams to ensure the company meets key submission milestones.

Represents the company at relevant industry forums.

What do you need to have?

Bachelor's degree or international equivalent

15 years' relevant experience including 7 years formal people management experience to include the following:

Detailed understanding of pharmaceutical drug or device development, product maintenance and global regulations and operations pertaining to labeling

Expertise in global guidance relevant to labeling, drug development and commercialization of prescription medicines and/or devices

Excellent understanding of applicable labeling requirements and guidance

Ability to strategize, communicate internally and with multiple clients on global labeling

Ability to resolve complex issues

In-depth knowledge of company people management policies and procedures, including hiring, performance management, corrective action and

Compensation administration

Advanced leadership skills including change management, people development, strategic thinking and influencing

Excellent written and oral communication skills

Ability to manage operational responsibilities across disciplines

Ability to translate high-level corporate strategy into long-range project plans to gain competitive advantage

Excellent Problem-Solving skills

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

This is a remote-based position!

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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 through the form below.

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