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Project Associate_Regulatory

  1. Sao Paulo, Mexico City
JR119481
  1. ICON Full Service & Corporate Support
  2. Project/ Program Management
  3. Office Based

About the role

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ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

What will you be doing?

Maintains study documents and utilizes company systems to manage the bioanalytical data in support of clinical/pre-clinical studies. Provides administrative support to project team members in bioanalytical operations and project management. Works with the project team to ensure that projects are completed in accordance with contract and client expectations:

  • Organizes project team and client meetings including scheduling, meeting materials, binders, agendas and meeting minutes and maintains these documents for regulatory submissions.
  • Organizes study information and supplies. Maintains project timelines, ensure project documents are up to date and stored properly, ensure laboratory team is properly notified of sample shipment and the sample manifests are uploaded so samples can be checked in and tracked.
  • Manages internal and client project reporting. Generates and reviews for accuracy reports to facilitate project status and financial reporting. Completes system updates and queries.
  • Supports project manager with financial tasks. Has oversight of purchase order process including creating and processing purchase orders for supplies and complete pass-through cost documentation.
  • May support preparation of study files by maintaining and distributing project documents. Ensures documents within the study folders are accurate and versioned appropriately.
  • Participates in and may lead project update meetings with Project Manager guidance to update sponsors of all current project information, send out agenda and minutes and ensure they are tracked for regulatory submission.
  • Assist in the review of supporting documentation and reports to support the project manager.
  • Uses the learning management system to assign project-specific training to team members and tracks training compliance.

What you need to have?

Education:

  • Complete Bachelor’s degree or international equivalent in health sciences or related field, preferred
  • Availability to work Office Based- Monday to Friday Location: Benito Juarez / Mexico City or Moema / São Paulo

Work experience:

  • CRO, pharmaceutical in the regulated bioanalytical industry experience, 0.5-2 years, preferred
  • Previous experience using computerized information systems and standard application software (Windows, MS Office)
  • High working knowledge with MS Word, PowerPoint, Excel and Outlook
  • Previous experience maintaining numerous Excel trackers, preferred
  • Previous experience building PowerPoint slides, preferred
  • Previous experience taking meeting minutes and facilitating and scheduling MS TEAMS and WebEx meetings, preferred
  • Advanced English Communication – Writing, Reading, Speaking


#LI-Onsite

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Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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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