Jobs for People with MS: National MS Society

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.

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.

The role:

This role is the point of contact responsible for Quality oversight of assigned sponsor portfolio/s. Responsible for developing and maintaining relationships with internal stakeholders and external customers providing compliance oversight and driving process improvement. Identifies compliance and quality trends and areas of potential compliance risk, proposes resolutions, oversees implementation of resolutions, and ensures effectiveness of solutions.

Responsibilities:

• Recognize, exemplify and adhere to ICON's values which center on Integrity, Accountability & Delivery, Collaboration, Partnership and Own IT@ICON

• Manage Projects, People and/or Audits relevant to the Functional area as appropriate for the position.

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.

• As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

• Identify changes and be aware of pending changes to GXP industry regulations and guidance’s worldwide.

• Acquire full awareness of sponsor’s book of work, client requirements, SOPs, deliverables, KQIs, KPIs and frequency of reporting.

• Support Review of all client-specific processes and documentation to ensure relevance to current agreements with the client as well as adherence to the processes outlined.

• Facilitates and/or ensures facilitation of all project, client and/or portfolio related quality issues (e.g. CAPAs) and ensures effectiveness checks are instituted in a timely manner.

• Support preparation and management of audits and inspections providing expertise and guidance to gain successful outcomes.

• Drive special projects surrounding Quality or Operations updates that require change management, client communication, and/or process updates.

• Review client related metrics, including assisting in metric collection as needed; investigate and troubleshoot quality issues from internally or externally driven complaints and/or client audits.

• Present at internal and external meetings, including analysis and presentation of Quality data, and respond to questions / requests as applicable.

• Attend Governance level meetings at the required frequency, participate in discussions and/or present quality topics and/or quality data.

• Act in a proactive, flexible and responsive manner to customer needs; communicate with clarity of purposes, setting clear direction.

• Provide innovation or enhancement to existing client relationships – this can include initiating forums to engage internal program teams on quality metrics/trends for their programs, implementing lessons learned for audits or inspection outcomes, partner with client on portfolio level initiatives.

• Advocate for the client with all internal departments to drive process improvement in all relevant areas.

• Proactively identify actions and areas for improvement at the portfolio/ Customer level.

• Provide technical/SME guidance to employees/colleagues and/or customers.

• Actively participate in or lead process improvement initiatives with the Q&C teams/ICON teams and ensure achievement of high-quality standards.

• Identifies and resolves technical and/or operational issues, drawing on company policies and guidelines and identifying exceptions for further review.

• To undertake other reasonably related duties as may be assigned from time to time.

Requirements:

• At least 3-5 years of QA experience in a GCP environment

• Strong stakeholder management skills and proven experience in a sponsor-facing role

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.