Epidemiology Research Assistant

RESPONSIBILITIES:
Conduct literature reviews and other background research needed for various regulatory documents and regulatory requests including:
- Epidemiology sections of the Risk Management Plans (RMP), Pediatric Investigational Plans (PIP), Periodic Safety Update Reports (PSUR)/Periodic Benefit Risk Evaluation Reports (PBRER) and orphan drug applications
- Epidemiology sections for other regulatory documents (eg ad-hoc regulatory requests)

Provide critical assessment of epidemiological data and literature relevant to safety issues.
Produce written summaries of literature assessments, focusing on synthesis of the body of references.
Maintain version control of documents and facilitate multiple rounds of review and revision.
As needed, conduct quantitative analyses of public use and private data sources
As needed, assist Epidemiologist with other Epidemiology deliverables, requiring literature review and summary, for development and product teams, including:
- Epidemiology Research Strategy
- Background epidemiology studies, natural history of disease studies and user characterization studies
- Post-approval safety studies and their feasibility assessments
- Other epidemiology studies (eg special subpopulations, new indications)

Support multiple product teams on epidemiology related issues as needed
Work collaboratively with key stakeholders internally and externally
Works under supervision of Epidemiologists. SKILLS:

PROFESSIONAL BACKGROUND AND EXPERIENCE:
Doctorate degree or Doctoral student in Epidemiology
1 or more years of work experience in epidemiology (in academia, pharmaceutical, regulatory agency, public sector, or other settings).
Familiarity with online medical literature search engines (eg PubMed, EMBASE, OVID, TDR's Incidence Prevalence Database).
Ability to critically appraise medical literature and synthesize a large numbers of studies.
In-depth understanding of and expertise in epidemiologic methods, including observational and experimental study designs and analysis
Excellent written and verbal communication skills.
Proficient at producing tables, figures, and slides.
Ability to manage multiple projects simultaneously
Ability to collaborate effectively with experts from diverse disciplines
Industry experience