ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
ICON Government and Public Health Solutions (IGP) is a full-service CRO specializing 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 an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ICON Government and Public Health Solutions has a distinct ability to provide rapid response efforts to global health crises.
IGP is recruiting for a Subject Matter Expert V to support the Center for Drug Evaluation and Research (CDER) and other appropriate centers across the FDA.
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.
Ph.D. in public policy, public health, health science, biology, chemistry, engineering, microbiology, pharmaceutics, physics, statistics, botanicals, business or related field.
Must be a U.S. citizen and able to obtain a Secret Clearance.
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
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
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. Thats why we are committed to developing our employees in a continuous learning culture one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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