Observational Research Manager (Epidemiologist)

Job Description

Company Overview

Job Description
Observational Research Manager (Epidemiologist)

Job Purpose
Leads and executes specific observational research projects within a product team or therapeutic area
Contribute to observational research throughout the product commercialization process

Key Activities
Conducting research to the highest standards of the profession
Aligning research with the product team’s medical strategies
Participating in initiatives to improve processes/capabilities in evidence generation activities

Key Activities and Skills
Conduct of the company-sponsored observational studies:

Develops study proposals and protocols in high quality
Conducts high-quality observational research to support medical strategy
Develops scientific manuscripts and presentations for a variety of audiences
Supports post-marketing surveillance using existing databases
Addresses regulatory and compliance requirements related to observational research
Manages vendors with controlling contract, budget, and timeline
Coordinates data purchase agreements
Facilitation of observational research and use of real-world evidence:

Contributes to medical strategy with observational research expertise
Contributes to real-world data analyses to support various business needs
Establishes processes for local observational research operations as needed
Collaborates with relevant internal/external stakeholders
Sets annual product-specific and personal goals
Takes leadership in a matrix environment
Promotes observational research awareness
Stays abreast of the latest developments in the field of observational research and drug development to contributes to the field

Basic Qualifications

Masters degree in Epidemiology or other subject with high observational research content or MD with observational research experience
· Three (3) or more years of clinical research and/or observational research experience in industry or academic settings
· Record of publications in clinical and/or observational research

Preferred Qualifications
· Doctorate in Epidemiology or other subject with high observational research content
· Experience in research to support drug development and/or pharmacovigilance in industry

Required Knowledge
· Observational research methodology and applications
· Programming in SAS or other software (e.g. STATA)
· Literature search
· Drug development processes and operations
· Relevant regulations and guidelines
· Written and oral scientific communications skills
· Project management/project planning
· Native level Japanese and Business English (oral and written)