Public Health Research Scientist (Regulatory Submissions)

22nd Century Limited, LLC; Mocksville (NC); On-site; USD 105,000 - 125,000; Full time

Job summary

22nd Century Limited, LLC is seeking a Public Health Research Scientist to oversee planning, execution, and interpretation of public health research to support FDA submissions. This role will focus on generating evidence to support APPH determinations and PMTA/SPMTA initiatives.

You will collaborate with Regulatory Affairs, Product Development, Analytical Chemistry, Quality, and CROs while leading literature reviews, study design, protocol development, and regulatory documentation.

Qualifications

• Master's degree or Ph.D. in Public Health, Epidemiology, Health Sciences, Behavioral Science, Clinical Research, Biostatistics, or a related scientific discipline.
• Minimum of three years of experience in public health research, clinical research, epidemiology, health outcomes research, or other evidence-based public health initiatives.
• Experience designing, coordinating, or supporting clinical and/or nonclinical research studies.
• Experience preparing and managing Institutional Review Board (IRB) submissions and ensuring compliance with applicable human subjects research requirements.
• Strong understanding of research methodologies, study design, and scientific data analysis.
• Experience conducting literature reviews, evidence synthesis, and interpreting scientific findings.
• Excellent scientific writing skills with experience preparing technical reports, study summaries, manuscripts, or other scientific documentation.
• Strong analytical, organizational, and project management skills.
• Excellent written and verbal communication skills with the ability to communicate complex scientific concepts to multidisciplinary audiences.

Responsibilities

• Design, coordinate, and support public health research initiatives that inform regulatory and scientific decision-making.
• Conduct systematic literature reviews and evidence syntheses to support research programs and regulatory submissions.
• Evaluate epidemiologic, behavioral, clinical, and population health data to assess potential public health impact of products.
• Identify scientific evidence gaps and recommend research strategies to address them.
• Assist in planning, coordination, and execution of clinical and nonclinical research studies.
• Develop and review study protocols, informed consent documents, case report forms, and study-related materials.
• Collaborate with internal teams and external research partners to ensure studies are conducted according to approved protocols and applicable regulations.
• Support interpretation and integration of study findings into broader scientific evidence packages.

Skills

Public health research

Scientific writing

Project management

Literature reviews

Regulatory science

Education

Master's degree or Ph.D. in Public Health, Epidemiology, Health Sciences, Behavioral Science, Clinical Research, Biostatistics, or related discipline

Job description

22nd Century Limited, LLC is seeking a Public Health Research Scientist to oversee planning, execution, and interpretation of public health research to support FDA submissions. This role will focus on generating evidence to support APPH determinations and PMTA/SPMTA initiatives.

You will collaborate with Regulatory Affairs, Product Development, Analytical Chemistry, Quality, and CROs while leading literature reviews, study design, protocol development, and regulatory documentation.