Regulatory Affairs Coord II

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Summary:

The Regulatory Affairs Coordinator II possesses substantial clinical research and regulatory knowledge; is capable of independent action in the development, application and maintenance of all regulatory documentation and activities within the Cook Children's System. This person may rely upon other Senior Regulatory Affairs staff for guidance, but is capable of managing a project with highest quality throughout its lifecycle. The Regulatory Affairs Coordinator II will further develop their knowledge of regulatory guidelines through independent study and external training, as appropriate.

Location:

• This position is remote but will need to be located in Texas due to some on-sight presence needed

Qualifications:

• Bachelor's degree in appropriate field (e.g., healthcare, social or health science, etc.) and minimum 5 years relevant clinical research, pharmaceutical or regulatory experience with at least 3 years regulatory affairs experience required; or an equivalent combination of education/certification and experience from which comparable knowledge and abilities can be demonstrated

• Computer proficiency in word processing and Excel required

• Knowledge of medical terminology required

• Knowledge of principles of research and federal regulations required

• Detail-oriented with strong organizational skills

• Excellent writing and editing skills

• Good interpersonal and communication skills required

• IRB Administration or Clinical Research certification required if used in lieu of education

About Us:

Cook Children's Health Care System

Cook Children's Health Care System offers a unique approach to caring for children because we are one of the country's leading integrated pediatric health care delivery organizations. Patients benefit from the integrated system because it allows Cook Children's to use all of its resources to treat a patient and allows for easy communication between the various companies by physicians with a focus on caring for children and adolescents.

Cook Children’s is an equal opportunity employer. As such, Cook Children’s offers equal employment opportunities without regard to race, color, religion, sex, age, national origin, physical or mental disability, pregnancy, protected veteran status, genetic information, or any other protected class in accordance with applicable federal laws. These opportunities include terms, conditions and privileges of employment, including but not limited to hiring, job placement, training, compensation, discipline, advancement and termination.