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Regulatory Affairs Specialist

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About the role

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"At ICON, it's our People that set us Apart"
 
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specializes in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 83 locations in 38 countries and has approximately 12,600 employees. Further information is available atwww.iconplc.com
 
Sr. Director Study Start Up
 
Role Responsibility
 
  1. Overall decision responsibilities in regard to resourcing, line management, training, functional delivery and agreeing high quality measurements within the SISA function
  2. Supporting the feasibility outreach in the region during proposal stage.
  3. Leading the overall delivery, through your SISA team, to drive execution of service, customer satisfaction, quality and efficiencies.
  4. Providing project oversight for all allocated studies.
  5. Provide effective management support to your team that delivers a high performing culture. Carrying out all relevant line management responsibilities including appraisals, goal setting and development plans.
  6. Responsible for hiring in the region whilst ensuring operations is conducted in line with relevant margins.
  7. Oversight and execution of all SISA, to achieve rapid site activation, ethical submissions, site contracts and drug release processes.
  8. Communicate with the VP Clinical and other peers in the region on all critical issues and business growth opportunities.
  9. Communicate with VP PMs on all client deliverables.
  10. Will support Business Development in the selling and understanding of the SISA function and how this is beneficial to the client’s deliverables and how we can reduce timelines.
  11. Developing key relationships with customers and where needed participate on customer satisfaction initiatives.
  12. Working closely with the functional head of SISA so that global consistency, focus and development are achieved across the Lead function Develop and maintain positive relationships with our clients.
  13. Drive innovation and continuous improvement in all areas of responsibility.
 
Benefits of Working in ICON
 
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
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