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我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成,他們的職場文化中,每個聲音都很重要,每一個貢獻都受到讚賞。 我們熱衷於洞察, 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心,成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本,熱切關懷,以科學贏得信任,以勇氣解決——有絕佳的機會等著您!加入我們,塑造我們和您的未來。有關更多資訊,請按兩下 here.
Role reports to:
Vice President Medical Affairs Americas位置:
North America, United States, New Jersey, Summit工作地點:
混合你會做什麼
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.
What we are looking for
Required
- Master’s or PhD in Epidemiology, Public Health, Biostatistics, or a related field.
- 3-7 years of experience in real-world evidence, epidemiology, or health outcomes research within the pharmaceutical, biotech, or healthcare sectors.
- Proficiency in analyzing large healthcare datasets (EHR, claims, registries, etc.) and applying epidemiological methods.
- Excellent communication skills with experience in scientific writing, presentations, and cross-functional collaboration.
Preferred
- Experience with artificial intelligence/machine learning (AI/ML) applications in RWE.
- Prior experience with regulatory interactions (FDA, EMA) related to real-world evidence submissions.
- Background in therapeutic areas such as oncology, neurology, cardiology, or rare diseases.
- Hands-on experience with statistical software such as SAS, R, Stata, or Python for epidemiological analyses.
- Strong understanding of regulatory guidelines related to real-world evidence and epidemiology.
- Knowledge of value-based healthcare and health economics (HEOR) principles.
對您有什麼好處
本職位新員工年薪底薪範圍:
這考慮了許多因素,包括工作地點、候選人的技能、經驗、教育水準和其他與工作相關的因素
有競爭力的福利待遇**
帶薪公司假期, 帶薪休假、志願者時間 &更多!
學習 &發展機會
Kenvuer Impact Networks
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