MANAGER EPIDEMIOLOGY & RWE

The Manager, Epidemiology & Real-World Evidence (RWE) is responsible for design and implementation of observational research studies utilizing real-world data (RWD) to generate vital epidemiological insights that support regulatory submissions and inform evidence-based decision-making. This role demands expertise in epidemiology, biostatistics, and health outcomes research to advance the organization’s strategic objectives within clinical development, market access, and medical affairs.

Key Responsibilities

Epidemiology & RWE Strategy

• Develop and execute real-world evidence generation strategies to support Kenvue’s drug development, regulatory submissions, and commercialization initiatives.
• Identify and assess epidemiological trends, disease burden, and treatment patterns to guide Kenvue’s clinical and medical decisions.
• Collaborate with cross-functional teams (medical affairs, clinical, regulatory, and commercial) to align RWE strategies with organizational goals.

Study Design & Execution

• Design and conduct observational studies, including cohort studies, case-control studies, and patient registries, utilizing electronic health records (EHR), claims databases, registries, and patient-reported outcomes (PROs).
• Prepare research protocols, statistical analysis plans, and study reports in compliance with regulatory and industry standards.
• Work closely with data scientists, biostatisticians, and external partners to ensure the quality and integrity of RWE studies.

Data Analysis & Interpretation

• Conduct epidemiological analyses to estimate incidence, prevalence, treatment effectiveness, and safety outcomes of Kenvue OTC product portfolio
• Interpret study findings within the context of clinical development, safety, and market access considerations.
• Communicate key insights effectively to internal and external stakeholders through presentations, publications, and conference abstracts.

Regulatory & Compliance Support

• Provide epidemiological evidence for regulatory submissions, post-marketing commitments, and risk management plans (RMPs).
• Ensure compliance with regulatory requirements (FDA, EMA, PMDA, etc.) and Good Pharmacoepidemiology Practices (GPP).
• Support pharmacovigilance activities by analyzing real-world safety data and evaluating risk-benefit profiles.

Stakeholder Engagement & External Collaboration

• Engage with key opinion leaders (KOLs), academic institutions, and research organizations to foster innovation in real-world research methodologies.
• Represent the organization in industry consortia and professional societies (ISPE, ISPOR).
• Publish research findings in peer-reviewed journals and present at scientific conferences.