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Job Description:

The Senior Manager, Epidemiology will work under the supervision of more senior members of the department. The primary responsibilities of the Senior Manager will be to:

• Assist with identifying research study needs, drafting proposals and protocols, and contributing to study conduct across the clinical development program in multiple therapeutic areas.

• May conduct fit for purpose database and study feasibility assessments and execute analyses across the product cycle.

• Conduct literature reviews and synthesis; and identify and evaluate data resources to meet therapeutic needs.

• Provide epidemiological and/or statistical consulting, education and support to product teams, and disseminate technical information through technical reports and presentation, as agreed by the team.

• Work will also include, both within and outside of existing electronic databases, researching natural history of diseases to understand the inherent risks associated with the indication; statistical risk assessment; using historical clinical trial data and other observational databases to develop an understanding of potential safety issues for new medications, and indications, based on experience with related compounds.

• May work in cross departmental/sector committees, and or other efforts supporting J& J Innovative Medicine.

• Keep up to date with the APAC Regulatory Agencies regarding regulatory requirements for Post Approval Authorization Studies and Risk Management plans and the development of formal guidance for use of RWE for Regulatory Decision Making.

• Identify and evaluate existing external electronic patient-level databases, and ongoing population-based studies relevant to therapeutic areas of interest in APAC region; explore and assess data sources to evaluate disease natural history, treatment patterns, and medication safety / benefit questions.

• Education:

  • Ph.D. in Epidemiology or a closely related field OR M.D. with training and degree in Epidemiology or a closely related field is required

• Experience and Skills:

• Required:

  • Minimum 3 year of hands-on experience in Epidemiology, outcomes research or related discipline

  • Excellent interpersonal and communication skills with multiple functional teams

  • Experience with understanding and the ability to interpret quantitative methods, and results interpretations of observational studies

  • Experience working with large administrative or medical records databases

  • Excellent communication skills in English & Japanese is required

• Preferred:

  • Experience working with health authorities

  • Experience with writing protocols in general

  • Phase III/IV experience

＜ For Internal Applicants＞

• Based on your experience and interview evaluation, the position title and level may vary.

• If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.

• For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral.