
Website FDA
Job Description:
As a Science Policy Analyst, the incumbent provides advice and consultation to Office management on program policy matters, including those in the incumbent’s scientific area of expertise. The incumbent will provide analysis and recommendations for the effective development of policy and program strategies in the assessment of quality information submitted in drug applications and lead quantitative and qualitative assessments of FDA policies and procedures related to pharmaceutical quality.
Job Responsibilities:
- Conducts cross-office policy working groups to facilitate timely and efficient policy decision-making and development of policy documents regarding the most complex issues.
- Cleary communicates polices to external parties, develops training, and identifies program areas affected by a policy matter.
- Participates in the development of responses to inquiries from interested parties external to OPQ, CDER, and FDA.
- Identifies the types of expertise needed to develop policy, and in coordination with affected program area, solicits and identifies participation of working group members with the appropriate expertise.
Job Requirements:
- Ability to communicate and work with staff across the organization and with differing expertise; demonstrated ability to collaborate across boundaries to work toward common goals.
- Possession of knowledge of regulatory policies, and procedures, related to the regulation of pharmaceutical quality is desired.
- Ability to identify and analyze problems; weight the relevance and accuracy of information; generate and evaluate alternative solutions; and make recommendations.
- Ability to work independently and as a contributing, collaborative team member.
- Ability to organize time effectively, determine priorities, and move work forward.
Qualification & Experience:
- Combination of education and experience with courses equivalent to a major previously listed plus appropriate experience or additional education.
Job Details:
Company: FDA
Vacancy Type: Full Time
Job Location: Silver Spring, MD, US
Application Deadline: N/A
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