SSU & Regulatory Specialist II - office based in Sao Paulo

Syneos Health is currently recruiting for a Start-up and Regulatory Specialist II to join our team in Sao Paulo.

The SSU&RS II function is:

Assumes responsibility on quality deliverables at the country level; follows project requirements and applicable country rules.
Forecasts submission/approval timelines and ensures they are compiled; if forecasted timelines are not reached: provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified.
Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
Reviews Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner and keeps training records updated accordingly.
Ensures continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.)

BA/BS degree in the science/health care field, legal degree, or equivalent combination of education and experience.
Moderate clinical research or related experience.
Demonstrated Subject Matter Expert knowledge of the overall drug development process with ability to present at Customer meetings.
Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations
Demonstrated clinical development and clinical research knowledge.
Excellent verbal, interpersonal, and written communication skills in both local and English language.
Good record retention and customer service skills.
Proficient in the use of computer and software systems (e.g., Excel).
Ability to successfully support internal and external customers.
Ability to develop, organize, and manage multiple tasks.
Ability to work independently.

Primary Location Latin America - avenida das nações - São Paulo

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