Food and Drug Administration (FDA)
Center for Drug Evaluation and Research (CDER)
Position: CONSULTANT/SENIOR CONSULTANT
Location: Silver Spring, MD
The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) is actively recruiting for several positions within the Office of Program and Strategic Analysis (OPSA). CDER is the global leader in drug regulation, responsible for ensuring the safety and effectiveness of all drug and therapeutic biological products used to treat, prevent, or diagnose illness.
Our office is responsible for leading and supporting a broad range of CDER programs, and our work both informs and influences organizational strategy and decision making by senior CDER management. We lead evaluations of new and existing initiatives to improve their implementation, understand their impact on the Center, and to develop strategy with respect to CDER’s external stakeholders. We also conduct a wide range of qualitative and quantitative analyses to answer key questions of CDER’s operations with the goal of enhancing the efficiency of key internal processes.
This is an exciting opportunity to join a highly motivated group modernizing FDA drug regulation operations. We offer a collegial, highly collaborative, and dynamic work environment in at the FDA Headquarters in Silver Spring, Maryland, a suburb of Washington D.C. Consultant positions are available as either one or two year ORISE fellowships or permanent positions at the GS 9‐13 level. Pay for both types of positions is commensurate with experience.
JOB DESCRIPTION
Our open positions are available in several groups within OPSA: the Program Evaluation and Implementation Staff; the Decision Support and Analysis Team; and the Lean Management Staff. Projects in these groups involve operational analyses to assess the impact of CDER initiatives on program efficiency and effectiveness; design and implementation of new programs; advancement of structured benefit‐risk assessment in regulatory decision‐making; and evaluation of key business processes using an evidence‐based approach that assesses the value of each step and leads to sustained practical solutions to complex problems. Our work often has a high impact on internal operations as well as our external environment.
Examples of recent OPSA work include strategic and financial analyses to inform negotiations of FDA user fee programs, designing a new system to better capture resource allocation, implementation of a new program in PDUFA to better understand patient perspectives on their treatment needs, and the first continuous process improvement evaluation for the review of patient labeling on drug products.
Many of our projects are not stated in explicit terms or with clearly defined objectives; therefore, the ideal candidate will demonstrate an ability to investigate an issue, pose specific questions to be addressed, and identify relevant variables and constraints, while effectively consulting with subject matter experts across the organization. We put forward analytical findings to senior CDER management, which entails translating the findings into reasonable, practical, and implementable proposals, which are also consistent with CDER policy and mandate.
As an OPSA staff member, you will have the opportunity to perform a variety of analyses on complex issues and frequently participate in the execution and implementation of your findings. Your responsibilities will often include determining the appropriate scope of analysis, designing the analysis, collecting relevant data, conducting qualitative and qualitative analyses, validating the data or results, and developing findings and actionable recommendations for CDER clients.
Key success criteria of individuals in these positions are exceptional consultant and interpersonal skills, a keen ability to manage large projects involving many stakeholders at varying levels in an organization, and a deep understanding of how to manage change in a large organization.
ADDITIONAL QUALIFICATION REQUIREMENTS
- Well‐developed ability to establish strong working relationships with individuals at all levels of an organization
- Exceptional analytical skills and experience analyzing qualitative and quantitative information
- Ability to effectively work on projects where goals and objectives are not well‐defined
- Unique ability to collect and assemble stakeholder input on a range of topics from various sources and then synthesize it into a coherent and concise summary report for technical experts, senior management, and the public
- Demonstrated ability to effectively communicate analyses to various audiences verbally and in writing; ability to prepare and deliver effective presentations of complex information
- Experience with managing projects/initiatives in the face of competing priorities and deadline
