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Reading, Pennsylvania, United States
Remote only
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.
Location: Open Globally
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 organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Global Head, Technical Regulatory & Quality including Global Chemical Manufacturing & Controls, Quality and MDD Services:
Provides global oversight and leadership to the teams supporting Chemistry, Manufacturing and Control (CMC), Quality and Medical Device & Diagnostic consulting services. Service provision includes strategic planning and development of CMC content for global dossiers, provision of Canadian QA Unit support, including agent, product release, compliance activities, logistics, and licensing, quality services for medical devices, in vitro diagnostics, and combination products, which also includes development, gap assessment, and remediation of quality systems against core standards and regulations.
Responsible for the strategic direction of the Technical regulatory CMC, Quality and MDD function, including driving business development strategies to grow and maintain the business with new and existing clients and for adapting to changing business needs, expanding to new regions and providing new services.
Drives innovation by building the internal capability to position the organization as a leader of high-quality and differentiated service provision.
Responsibilities:
Qualifications:
• Expert understanding of scientific principles and regulatory technical CMC, Quality and MDD requirements relevant to global drug development and post marketing support
• Expert knowledge of review and approval processes of applicable regulatory Health Authorities / Notified Bodies
• Expertise in pharmaceutical drug and device development, product maintenance and global regulations and operations pertaining to product development strategy, registration and maintenance
• Ability to serve as lead in international Agency Interactions and product development meetings
• Advanced leadership skills including change management, people development, strategic thinking and influencing
• Ability to manage time and resources required for multiple projects
• Excellent ability to plan, organize and deliver multiple or complex projects, according to agreed deadlines.
• Excellent ability to understand complex issues and propose creative and achievable solutions
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.
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:
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
