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Epidemiology Specialist
Eingestellt von Synectics
Gesuchte Skills: Natural
Projektbeschreibung
Propose and carry out various components of Epidemiology deliverables for one product team.
INCLUDING:
- Epidemiology Research Strategy
- Epidemiology section of the Risk Management Plan (RMP), Pediatric Investigation Plan (PIP) and Periodic Benefit Risk Evaluation Report (PBRER)
- Epidemiology sections for other regulatory documents (eg 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 (eg special subpopulations, new indications)
- Participate in Risk Management Committee activities and apply epidemiologic methods to address safety and benefit/risk issues
- Provide critical assessment of observational data, epidemiological data and literature relevant to safety issues
- Development of observational study protocols, directing analyses, and interpreting/summarizing findings
- 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
- Work collaboratively with key stakeholders internally and externally
- Interact with regulatory agencies on epidemiologic issues as needed
SKILLS/BACKGROUND:
- In-depth understanding of and expertise in epidemiologic methods, including observational and experimental study designs and analysis
- Understanding and experience with patient reported outcomes and health economics preferred
- Clinical background a plus
- Excellent written and verbal communication skills
- Ability to manage multiple projects simultaneously
- Epidemiology
- 2 years or more in epidemiology or outcomes research in the pharmaceutical industry, academia, and/or regulatory agencies
- Masters or Doctorate level
- Desired professional level: Entry-level with at least 2 years or more in epidemiology or outcomes research in the pharmaceutical industry, academia, and/or regulatory agencies
Projektdetails
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Einsatzort:
New York, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung