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Associate Director, Regulatory Submissions

Associate Director, Regulatory Submissions

Medpace, Inc.São Paulo, Brasil
Há 3 dias
Descrição da vaga

Job Summary :

As our activities in Latin America are developing rapidly, we are currently looking for a full-time, office-based, Associate Director, Regulatory Submissions, based in Sao Paulo, Brazil to join our Site Activation & Maintenance team.

This position will allow you to join a key team in the success of the company.

If you want to develop your career in a stimulating environment, promote your experience and go even further, this position represents a real opportunity for you.

Responsibilities :

  • Direct all operations of Regulatory Submissions department;
  • Oversee hiring, training, evaluation, and retention of employees;
  • Maintain departmental Standard Operating Procedures (SOPs);
  • Provide oversight to Regulatory Submissions personnel;
  • Evaluate departmental capacity needs on an ongoing basis and coordinate / delegate efficiently and in accordance with given timelines;
  • Manage and provide accountability of the start-up and maintenance phases of global programs across all regions and various therapeutic areas;
  • Serve as a primary Sponsor contact for all start-up specific issues and study deliverables;
  • Maintain a thorough knowledge of country start-up processes and requirements;
  • Oversee the progression of site activations ensuring quality, accuracy, and timeliness for assigned projects; and
  • Manage risk assessment and related mitigation strategy execution related to study start-up.

Qualifications :

  • Willing to work office-based in Sao Paulo at least 3 days per week;
  • Bachelor's degree in a health or science related field required, advanced degree preferred;
  • 5+ years as a Start-up Manager or Clinical Trial Manager within a CRO;
  • Experience managing coordinator level employees;
  • Experience supporting new business opportunities; and
  • Strong leadership and management skills
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