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Job Details


PRA Health Sciences

Subject Matter Expert V

Pharmaceuticals

All

Full Time

On Site

No

Baltimore, Maryland, United States

Duties/Responsibilities:

  • Defines problems and analyzes and develops plans and requirements in the subject matter area for moderately complex-to-complex systems.
  • Coordinates and manages the preparation of analysis and evaluations.
  • Provides recommendations for proper implementation of programs and systems specifications.

Qualifications:

  • Ph.D. in public policy, public health, health science, biology, chemistry, engineering, microbiology, pharmaceutics, physics, statistics, botanicals, business or related field.

Purpose:

  • The Scientific Services Task Areas are intended to provide scientific professional services to appropriate FDA Centers. The Scientific Services acquisition aligns with the Mission/Business Needs within CDER's Acquisition Strategy (Approved 2017). Specifically, the scientific research, technical guidance, analysis, laboratory and reporting services will enable applicable Centers and offices to accomplish FDA science objectives

Scope:

  • The scope encompasses a range of professional services activities necessary to support the Center for Drug Evaluation and Research (CDER) and other appropriate centers across the FDA in six (6) areas: (1) Research and Technical Guidance, (2) Scientific Consultation (IT and Information Management Systems), (3) Scientific Investigations, Procedures and Analysis, (4) Publishing, (5) Laboratory Technical and Administrative Support, and (6) Task Management services, to be applied across all tasks

ICON Government and Public Health specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.