Senior Project Manager, Regulatory Labelling

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.Job Role

The Senior Project Manager will support with expanding business growth within the Language Services team through Regulatory Labelling authorization services. We need to hire an expert with a high level of specialty and expertise in this complex process. This expertise is essential to train our Project Management and Client Services departments, ensuring they can handle these projects. The new hire will lead the setup of training programs and expedite our service offerings, enabling us to strategically enhance our portfolio.

Responsibilities

• Lead the training plans for Regulatory Affairs within the Language Services department

• Primary point of contact for designated complex, single service projects and responsible for developing successful working relationships with clients (internal and external), and ensure repeat business return to ICON

• Responsible for project scheduling and implementation, resource requirements and deliverables

• Develop and maintain project management plans

• Responsible for developing workflows for Regulatory Affairs language services within the organization

• Responsible for risk mitigation strategies, associated action plan and issue resolution

• Responsible  for   managing  cross-functional   project   team 

• Provide direction and support to project team

• Manage projects in accordance with the contract budget and contracts

• Collaborate with Client Services to ensure successful completion of change orders

• Managing relevant invoicing procedures and revenue recognition, as needed

• Track project deliverables using appropriate tools

• Effectively monitor and report on progress of the project to all stakeholders

• Implement QC activities as necessary and monitor relevant quality metrics

• Develop a succession plan and in the event of a change to the team, ensure an effective hand-over

• Organizes and monitors workloads of department or functional team.

• Other duties as assigned

You Are

• Educated to a degree level preferable within the life sciences sector or relevant experience

• Experienced with localization project manager

• Strong Regulatory Affairs Labelling experience

• Strong attention to detail and well organised with an ability to manage multiple complex projects

• Adaptable and able to problem solve effectively

• Strong communicator with an ability to present to various audiences

Benefits of Working in ICONOur 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.