Epidemiology Research Assistant

Job description

Job Description- • 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 (e.g. 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. 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), Paediatric Investigational Plans (PIP), Periodic Safety Update Reports (PSUR)/Periodic Benefit Risk Evaluation Reports (PBRER) and orphan drug applications • Epidemiology sections for other regulatory documents (e.g. ad-hoc regulatory requests) • Provide critical assessment of epidemiological data and literature relevant to safety issues. • 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 (e.g. 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 No Travel/No Overtime. A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.