Food and Drug Administration, Center for Drug Evaluation and Research, Office of Regulatory Policy
September 24, 2018
Silver Spring, Maryland
Full Time - Experienced
Department of Health and Human Services (HHS)
Food and Drug Administration (FDA)
Center for Drug Evaluation and Research (CDER)
The Center for Drug Evaluation and Research (CDER) located at the Food and Drug Administration (FDA) in Silver Spring, MD is recruiting to fill the position of Director, Office of Regulatory Policy. FDA is a Federal scientific, regulatory, and law enforcement agency with the statutory responsibility to promote and protect the health of the American public. FDA’s programs are national in scope and effect, and its activities directly affect and heavily impact multi-billion-dollar industries and every American.
CDER is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs. CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotional activities; review, monitoring and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law.
The Office of Regulatory Policy (ORP) provides Center oversight and leadership in the development of regulations, policies, procedures, and guidances that pertain to the drug approval process. ORP’s oversight extends to the disclosure of official records and information under the Freedom of Information Act, Privacy Act, other statutes, and FDA’s public disclosure regulations. The Director of ORP reports directly to the CDER Deputy Center Director for Regulatory Policy.
Participates in and contributes to top level Center, Agency, or Department discussions, meetings and conferences on broad policy matters and issues. Advises the Deputy Center Director for Regulatory Policy, other CDER leadership including the Center Director, senior FDA officials, and others on all regulatory and policy making activities that affect Center-wide programs, projects and initiatives or have an impact on the development and execution and long-range program goals.
Collaborates with the Deputy Center Director for Regulatory Policy and other key Center or Agency officials in developing policy regarding pre-market product approval issues, drug labeling, drug production/processing/packaging and new/novel and emerging drug technologies.
Provides executive leadership, management and technical direction to ORP in formulating, developing and shaping CDER’s short and long-range goals advancing programs and understanding FDA’s responsibilities for enforcing regulatory standards to protect the consumer against adverse effects and fraud. Represents ORP at senior level meetings for cross-center governance activities (budget, personnel, IT). Responsible for active management and development of ORP staff, which currently includes five divisions (each headed by a Division Director), approximately 130 FTEs, and is a varied and diverse workforce comprised of lawyers (regulatory counsels), project managers, and administrative professionals.
Evaluates ORP’s overall efforts and activities, and as necessary, develops, establishes or recommends regulations and policies to the Deputy Center Director for Regulatory Policy and other CDER leadership including the Center Director. Develops documents and recommends policies involving criteria for specific classes of products or concerning problems arising with respect to new or approved products and evaluations of regulatory policies for the various types of products.
Works closely with the Office of Chief Counsel (OCC) to support and inform OCC’s provision of legal advice and litigation support related to CDER-regulated products.
As the ORP Director, provides authoritative advice, guidance, assistance, interpretations, and recommendations to the Deputy Center Director for Regulatory Policy, other CDER leadership including the Center Director, key agency officials, program directors, professional personnel, departmental representatives, intra/inter governmental counterparts and others on problems related to Center regulated products. Furnishes expert advice and comments on matters related to existing and proposes programs and regulations.
Desired Experience and Qualifications:
Possess a juris doctorate degree from an accredited institution of higher learning.
Ability to develop networks and build alliances; collaborates across boundaries to build strategic relationships and achieve common goals.
Ability to identify the internal and external politics that impact the work of the organization. Perceives organizational and political reality and acts accordingly.
Understands and keeps up-to-date on local, national, and international policies and trends that affect the organization and shape stakeholders' views; is aware of the organization's impact on the external environment.
Ability to builds and manage the workforce based on organizational goals, budget considerations, and staffing needs. Ensures that employees are appropriately recruited, selected, appraised, and rewarded; takes action to address performance problems. Manages a multi-sector workforce and a variety of work situations.
Ability to identify and analyze problems; weighs relevance and accuracy of information; generates and evaluates alternative solutions; makes recommendations.
Ability to lead people towards meeting the organization's vision, mission, and goals.
Skill in applying FDA regulations and laws, historical and legal precedents, regulations, guidelines, policies and procedures for relevant programs.
Knowledge of human drug regulations and policies as they relate to the Center’s broad national and international programs and activities to ensure the safety, efficacy, and labeling of all human drug products.
Silver Spring, MD (White Oak Campus)
Salary and Incentives
Salary is commensurate with education and experience. Optional incentives may be authorized.
Area of Consideration:
Applications will be accepted from all qualified applicants.
All qualified candidates can submit curriculum vitae and cover letter in which you describe why you feel you are uniquely qualified for this position electronically to Ashley Corum-Lawson, Ashley.CorumLawson@fda.hhs.gov.
**First round cutoff date for applications is October 22, 2018. To ensure consideration, submit application prior to cutoff date.**
How You Will Be Evaluated:
A review of your resume and supporting documentation will be made to determine if you are qualified for this job based on how well you meet the desired qualifications above. If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview.
As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have - whether you’re a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you’re eligible under their policies. You can find information about each program at https://www.opm.gov.
Conditions of Employment:
*U.S. Citizenship is required*
Ethics Requirements: This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. Selectee for this position will be required to file a Confidential Disclosure Report (OGE 278) and may require the selectee to obtain clearance from the FDA Division of Ethics and Integrity before a final offer can be made. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at http://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/default.htm.
Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant’s successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security investigation or supplemental investigation may be required later. Applicants are also advised that all information concerning qualification is subject to investigation. False representation may be grounds for non-selection and/or appropriate disciplinary action.
EEO Responsibility: The incumbent is responsible for furthering the goals of equal employment opportunity (EEO) by taking positive steps to assure the accomplishment of affirmative action objectives and by adhering to non-discriminatory employee practices in regard to race, color, religion, sex, national origin, age, or handicap. Specifically, as a manager, incumbent initiates non- discriminatory practices and affirmative action for the area under his/her supervision in the following: 1) merit promotion of employees and recruitment and hiring of applications; 2) fair treatment of all employees; 3) encouragement and recognition of employee achievements; 4) career development of employees; 5) full utilization of their skills.
Reasonable Accommodation Policy: Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.
Additional Salary Information: Salary is commensurate with education and experience. Optional incentives may be authorized.
Internal Number: FDA-CDER-ORP-18-DE-201809
About Food and Drug Administration, Center for Drug Evaluation and Research, Office of Regulatory Policy
The Office of Regulatory Policy (ORP) provides oversight and leadership to the Center in the development of policies and procedures related to the regulation of human drugs. Composed of five divisions, ORP is responsible for managing the development of new regulations and policies under the Federal Food, Drug, and Cosmetic Act and other applicable authorities.