Public Health Advisor

Cherokee Nation Integrated Health (CNIH) is looking for a Public Health Advisor to join our vibrant team in Atlanta, GA. In this position, you will be pivotal in maintaining and applying extensive, current expertise on FDA regulations concerning drugs, vaccines, and medical devices, particularly in the context of public health preparedness and emergency response. Additionally, you will provide critical clinical, scientific, regulatory, and technical expertise on the use of medical products for various threat agents.

Responsibilities

·        Develop and enhance protocols and regulatory applications for the utilization of medical products in the Strategic National Stockpile (SNS) or those exclusively available through CDC.

·        Research and analyze data to support the initiation and development of regulatory mechanisms such as Investigational New Drug Applications and Emergency Use Authorizations.

·        Manage and evaluate protocol amendments, safety reports, and regulatory submissions, ensuring compliance with FDA requirements.

·        Perform reviews of scientific and clinical data, communicating findings to CDC experts and stakeholders to inform public health decisions.

·        Create and edit a variety of scientific, technical, and regulatory documents, including clinical protocols, SOPs, and policy documents.

·        Provide regulatory support and guidance on medical countermeasures during public health emergencies, maintaining up-to-date knowledge of relevant policies and regulations.

·        Performs other job-related duties as assigned.

Qualifications

·        Advanced degree (Master’s or PhD) in Public Health, Regulatory Affairs, or related discipline preferred.

·        Bachelor’s degree in Public Health, Health Sciences, Regulatory Affairs, or a related field required.

·        Minimum of 5 years of experience in public health, regulatory affairs, or related fields.

·        Experience in managing regulatory applications and submissions for medical products.

·        Proven track record in developing and enhancing protocols and documentation for public health programs.

·        Experience in handling emergency response situations, particularly those involving medical countermeasures.

·        Strong knowledge of FDA regulations related to drugs, vaccines, and medical devices.

·        Proficiency in data analysis and interpretation, particularly in the context of public health.

·        Excellent written and verbal communication skills, with the ability to convey complex regulatory information clearly.

·        Proficient in using relevant software applications (e.g., Microsoft Office Suite, data analysis tools).

·        Ability to develop, analyze, and enhance regulatory protocols and documentation effectively.

·        Strong organizational skills and attention to detail in managing multiple projects and deadlines.

·        Ability to work independently as well as collaboratively within a team.

·        Capability to maintain up-to-date knowledge of relevant public health policies, regulations, and scientific advancements.

·        Ability to provide clear and concise regulatory guidance and support during public health emergencies.

·        Must pass pre-employment qualifications of Cherokee Federal.