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Public Health Specialist
2 months ago
We are seeking a highly skilled Public Health Advisor to join our team at Cherokee Nation Businesses. As a Public Health Advisor, you will play a critical role in maintaining and applying extensive expertise on FDA regulations concerning drugs, vaccines, and medical devices.
Key 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.
- 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.
