Operations Support Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro US$40.000 - US$60.000
Job Title: Regulatory Operations Associate">

As a key member of our team, you will be responsible for providing support for submissions and other documents by performing necessary tasks including assembly, dispatch and coordinating resources for submissions to CTIS. You will also maintain submission components associated with a regulatory submission, as required, and perform quality review of Regulatory Operations team members work to ensure accuracy.

Responsibilities:
  • Provide support for submissions and other documents by performing necessary tasks including assembly, dispatch and coordinating resources for submissions to CTIS
  • Maintain submission components associated with a regulatory submission, as required
  • Perform quality review of Regulatory Operations team members work to ensure accuracy
  • Participate in submission teams, maintaining necessary liaison between both project leader, and when applicable, with client
  • Manage project workflow throughout the submission process, including prioritizing project objectives, and overseeing progress of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs when required
  • Maintain current knowledge of applicable regulations and industry best practices. Participate in the interpretation of guidelines and impact assessment to current work procedures. Anticipate Regulatory consequences and advise project teams on publishing issues and strategies.
  • Participate in and conduct formal interactions (face-to-face meetings, teleconferences, etc.) with project teams and government agencies in a polite and professional manner
  • Assist in the design and implementation of new processes or initiatives within the department
  • Participate in special projects and carry out assigned activities in support of the Publishing function
Required Skills and Qualifications:

  • Microsoft Office
  • Advanced English for Writing / Reading / Speaking
  • A high school diploma and/or equivalent
  • Desirable Clinical Trials exp. but not essential
  • Degree in Health is a plus
  • Previous experience in administration is preferred
  • Excellent communication skills
  • Ability to work independently
  • Ideally you will have 1-2 years relevant experience
Benefits:

  • 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.
  • We provide a comprehensive and competitive total reward package that comprises an excellent level of base pay, variable pay and recognition programs, employee benefits, supportive policies and wellbeing initiatives tailored to support you and your family at all stages of your career.
Others:

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.

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