Associate Director, Regulatory Submissions
3 semanas atrás
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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