Public Health Research Scientist in Mocksville, North Carolina at 22nd Century Limited, LLC

Public Health Research Scientist

Position Summary

The Public Health Research Scientist supports the planning, execution, and interpretation of public health research to advance the company's scientific and regulatory objectives. This position plays a key role in generating and evaluating evidence to support FDA applications such as the Premarket Tobacco Product Applications (PMTAs) and Supplemental PMTAs (SPMTAs), with a focus on demonstrating that products are appropriate for the protection of public health (APPH).

The successful candidate will collaborate with cross-functional teams to develop research strategies, oversee clinical and nonclinical studies, conduct scientific literature reviews, interpret research findings, and prepare high-quality scientific documentation. This role requires a strong foundation in public health research, human subjects research, and scientific communication.

Organizational Placement

The Public Health Research Scientist is a member of the Research and Development (R&D) department and reports directly to the Vice President of Science and Technology.

This position serves as the primary subject matter expert in public health research within the R&D team and works collaboratively with internal and external team members from Regulatory Affairs, Product Development, Analytical Chemistry, Quality, and CROs. The role provides scientific expertise that supports product development, evidence generation, and FDA regulatory submissions, while contributing to the company's overall research and innovation strategy.

As a member of a growing organization, the Public Health Research Scientist is expected to work collaboratively across functional areas, adapt to evolving business priorities, and contribute wherever scientific expertise is needed to support the company's mission and strategic objectives.

Essential Responsibilities

Public Health Research

• 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 the potential public health impact of products.
• Identify scientific evidence gaps and recommend research strategies to address them.

Clinical and Nonclinical Research Support

• Assist in the 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 the interpretation and integration of study findings into broader scientific evidence packages.

Human Subjects Research and Regulatory Compliance

• Prepare and manage Institutional Review Board (IRB) submissions, amendments, continuing reviews, and study closeout documentation.
• Ensure research activities comply with applicable ethical standards and regulations governing human subjects research.
• Maintain documentation supporting research compliance and study oversight.

Regulatory and Scientific Support

• Contribute scientific evidence to support PMTA and SPMTA submissions and other regulatory initiatives.
• Prepare scientific summaries, technical reports, literature reviews, and regulatory documentation.
• Assist in responding to regulatory information requests by compiling and interpreting scientific data.
• Collaborate with Regulatory Affairs to ensure scientific documentation aligns with regulatory expectations.

Cross-Functional Collaboration

• Coordinate activities with contract research organizations (CROs), academic collaborators, consultants, and external investigators.
• Present research findings and scientific recommendations to technical teams and leadership.

Required 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.

Preferred Qualifications

• Experience supporting FDA regulatory submissions, including PMTA, SPMTA, IND, NDA, 510(k), De Novo, IDE, or similar regulatory pathways.
• Experience in tobacco regulatory science, pharmaceuticals, medical devices, consumer health products, or other regulated industries.
• Knowledge of Appropriate for the Protection of Public Health (APPH) evaluations or population health assessment methodologies.
• Experience with behavioral science, epidemiology, nicotine dependence research, abuse liability, consumer perception, or health outcomes research.
• Experience collaborating with contract research organizations (CROs), academic institutions, or government agencies.

Knowledge, Skills, and Abilities

• Strong understanding of public health research principles and evidence evaluation.
• Ability to critically evaluate scientific literature and translate findings into actionable insights.
• Knowledge of clinical research methods and ethical oversight of human subjects research.
• Strong scientific writing, editing, and presentation skills.
• Ability to manage multiple projects and competing priorities while maintaining attention to detail.
• Strong interpersonal skills with the ability to build effective working relationships across scientific, clinical, and regulatory functions.
• Commitment to scientific integrity, quality, and continuous learning.

Adaptability and Collaboration

• As a growing organization, we value team members who are flexible, resourceful, and eager to contribute wherever needed. While this position has primary responsibilities in public health research, success in this role requires a willingness to wear multiple hats and support a variety of cross-functional initiatives.
• The ideal candidate is comfortable working in a dynamic environment where priorities may shift. This may include assisting with regulatory strategy, scientific writing, project coordination, process improvement, or other activities that advance the company's mission and regulatory objectives.
• We are looking for someone who is proactive, collaborative, and motivated to help build a high-performing organization by taking ownership, solving problems, and supporting teammates as needed.

Success Measures

Success in this role will be demonstrated by:

• Delivery of high-quality scientific research and documentation that supports regulatory and business objectives.
• Effective coordination and oversight of research activities and IRB processes.
• Timely completion of assigned research projects and regulatory deliverables.
• High-quality literature reviews and evidence syntheses that inform strategic decision-making.
• Strong collaboration across cross-functional teams and external research partners.
• Accurate, well-supported scientific analyses and technical reports.

Working Relationships

This position works closely with:

• Regulatory Affairs
• Clinical Affairs
• Product Development
• Toxicology
• Analytical Chemistry
• Biostatistics
• Quality Assurance
• External Contract Research Organizations (CROs)
• Academic collaborators
• Public health researchers and scientific consultants

Travel

Occasional travel (up to 15%) may be required for investigator meetings, scientific conferences, research site visits, or collaboration with external partners.