Research Associate

  • location: Collegeville, PA
  • type: Contract
  • salary: $33.68 - $39.62 per hour
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job description

Research Associate

job summary:

Job Title: Research Associate II

Job Responsibilities

  • Propose and carry out various components of Epidemiology deliverables for development and product teams, including:
  • Epidemiology Research Strategy
  • Epidemiology section of the Risk Management Plan (RMP) and Pediatric Investigational Plan (PIP)
  • Epidemiology sections for other regulatory documents (e.g., ad-hoc regulatory requests)
  • Background epidemiology studies, natural history of disease studies and user characterization studies
  • Post-approval safety studies and their feasibility assessments
  • Other epidemiology studies (e.g., special sub-populations, new indications)
  • Participate in Risk Management Committee activities and apply epidemiologic methods to address safety and benefit/risk issues
  • Provide critical assessment of epidemiological data and literature relevant to safety issues
  • Conduct quantitative analyses of public use and private data sources as needed
  • Present and publish results of epidemiological studies at scientific conferences and peer-reviewed journals
  • Support multiple product teams on epidemiology related issues
  • Work collaboratively with key stakeholders internally and externally
  • Interact with regulatory agencies on epidemiologic issues as needed
Education & Qualifications

  • PhD in Epidemiology, DrPH or SCD (preferred)
  • MS in Epidemiology or MPH with a concentration in epidemiology
  • In-depth understanding of and expertise in epidemiologic methods, including observational and experimental study designs and analysis
  • Demonstrated ability to design and conduct high-quality epidemiological studies in the pharmaceutical industry, academia, and/or regulatory agencies
  • Excellent written and verbal communication skills
  • Ability to manage multiple projects simultaneously
  • An understanding of drug development process, including regulatory aspects
  • Experience with statistical software packages (e.g., SAS, SPSS or Stata)
  • In-depth knowledge of public and private epidemiologic resources and database
  • Ability to collaborate effectively with experts from diverse disciplines

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

location: Collegeville, Pennsylvania
job type: Contract
salary: $33.68 - 39.62 per hour
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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