Purpose: FDA, one of our Nation's oldest consumer protection agencies, ensures the safety of foods and cosmetics and the safety and efficacy of pharmaceuticals, biological products, and medical devices. Its employees monitor the manufacture, import, transport, storage, and sale of about $1 trillion worth of products each year. Commissioned Corps officers from all professions are assigned to the FDA and serve in various capacities to advance the agency's mission.

For the Liaison please click the following link:

https://dcp.psc.gov/ccmis/PDF_docs/sgpac.pdf

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POSITION TITLE

Medical Officer (O-6), non-supervisory

FDA/CDER/OSE/RSS

Position: MO Vacancy

 LOCATION DESCRIPTION

The position is with the Sentinel Program Team located within the Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE), Regulatory Science Staff (RSS). The Sentinel Program Team manages the daily operations of the Sentinel System, a large multisite distributed database, created in 2009 to meet a Congressional mandate to improve safety surveillance of medical products after FDA approval. The Sentinel System is a multidimensional program with active operations in all divisions in OSE, Office of Medical Policy, CBER, and CDRH, and a coordinating center at the Harvard Pilgrim Healthcare Institute. The Sentinel Program Team also works closely with CDER’s Office of Biostatistics, Office of New Drugs and the Office of Generic Drugs.

 The incumbent will serve as a medical officer who will support the program’s scientific operations, assist with planning for infrastructure development, develop or enhance policies and procedures to ensure the program’s integration into the drug approval process, and assist with the complex coordination needs for this large cross-Agency active safety surveillance system. A key part of this position will be to support the ongoing development of Sentinel’s Active Risk Identification and Analysis (ARIA) system, the component of Sentinel that is routinely used to address serious safety concerns emerging from the drug approval process and routine post-approval safety surveillance.

 This position is at the FDA White Oak Campus, in Silver Springs, MD.

JOB DESCRIPTION

Specific duties and responsibilities include, but are not limited to the following:

• Provide clinical and epidemiological expertise to CDER teams assessing the safety of drug products using the Sentinel System, including:
  • providing guidance on the capabilities of ARIA to assess drug safety issues,
  • developing new electronic algorithms to improve the study of important safety concerns,
  • improving the scientific operational framework for ARIA analyses,
  • advancing the methods, tools and data inside of the Sentinel System to enhance safety surveillance capabilities
• Assist with meeting the coordination and communication demands that emerge from Sentinel’s Agency-wide governance structure involving senior leaders from CDER, CBER, and CDRH.
• Coordinate internal and external communications that involves promulgation of key scientific capabilities of Sentinel and ARIA to diverse audiences, responding to media inquiries, leading staff training for a wide variety of different offices, interfacing with the myriad stakeholders inside and outside of FDA, including at the Sentinel Coordinating Center and Data Partners.
• Develop new measures to track key programmatic outcomes to ensure that Sentinel continues to achieve and is able to report upon the goals set by the Executive Sponsor of Sentinel, and Sentinel’s Governance Board, comprised of Center-level leadership at CBER, CDER, and CDRH.
• Contribute to policy and process development for the Sentinel System.
• Assist with tracking, standardizing, and improving the use of the Sentinel System in post-approval safety surveillance and ensuring the wise and equitable use of Sentinel’s resources.
• Present at local and national conferences to disseminate scientific and programmatic achievements.

 Required knowledge, skills and abilities

• Board certification in a clinical specialty with 3+ years of clinical experience and/or clinical subspecialty training desired, but not required.
• Knowledge of the clinical context for how drugs are used, current clinical care guidelines and their relationship to a product’s indication, and understanding the diagnosis and treatment standards of medical conditions that are routinely the subject of safety surveillance analyses.
• Solid foundation in epidemiology and biostatistics.
• Prior experience conducting studies in claims-based databases strongly desired.
• Knowledge and experience with drug approval applications, ICH guidelines, and key aspects of post-approval safety surveillance (e.g., PSURs, PBRERs, REMS) desired.
• Strong interpersonal and communication skills, especially in preparing and presenting complex technical material to diverse audiences.
• Ability to plan and manage complex multi-stage projects involving a multidisciplinary team.
• Ability to establish effective relationships with staff inside and outside of FDA, and work with staff reviewers as well as management.
• Skill in prioritizing and organizing multiple tasks.
• Flexibility to work in a fast-paced environment with rapidly evolving priorities.
• Experience and skill in publishing in scientific peer-reviewed journals.
• Ability to work independently and in a team environment.
• Performs other duties as assigned.

Contact: Michael.Nguyen@fda.hhs.gov

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DIrector of Patient Engagement, O6 billet, open to O4-O6. Located in Silver Spring, MD. Closes 5/10/17

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Job Title: Supervisory Program Specialist, Branch Chief, Grade O-6,  Multidisciplinary Billet Medical Services Branch

Organization: U.S. Department of Health and Human Services (DHHS), Office of the Assistant Secretary for Preparedness and Response, Office of Emergency Management, Division of the National Disaster Medical System (NDMS)

Location: Washington, DC

Closing Date: May 19, 2017

Agency leadership has determined that this position meets Criteria 3: Assignment requires individual to be available for rapid deployment – domestic or international – at the direction of the agency head (as distinguished from deployment for natural disaster or international response) or requires availability to perform duties 24/7, including when on leave.

Job Description:

This position is located with the U.S. Department of Health and Human Services (DHHS), Office of the Assistant Secretary for Preparedness and Response, Office of Emergency Management, Division of the National Disaster Medical System (NDMS).

The Supervisory Program Specialist, Branch Chief will work under the direction of the Director, National Disaster Medical System (NDMS) and supervises a diverse staff of clinicians and non-clinicians to accomplish complex projects, programs and/or assignments.

The incumbent performs and supervises programmatic activities such as the steady-state programmatic and response/event operational activities that include cross-matrix collaboration with the NDMS Federal Partnership and state stakeholders;, human capital management; budgetary formulation and execution; stakeholder engagement; and administrative management functions necessary for accomplishing the mission of the Division.

The incumbent also plans, manages, and directs programs, policies, and activities of subordinate staff related to the NDMS.  Develops and implements internal, interagency and external policy development, operations, and communications regarding programmatic support which includes human capital management and business acumen.

The incumbent must demonstrate mastery of a wide range of methods for the assessment and improvement of complex programs, processes and systems; as well as skills to plan, organize, and implement the required programs, plans, and proposals involving substantial department resources, or that require extensive changes in established procedures.

Qualifications:

The position requires an individual with strong written and verbal communication and

interpersonal skills; someone who is highly motivated and able to perform in an accelerated environment.

The incumbent is expected to provide field response support during ESF #8 operations as required. This is a multidisciplinary billet with a clinical and/or health services background preferred.

Contact information:

To apply please e-mail your CV, cover letter, last 2 COERS, and 2 professional references to oemphs@hhs.gov. The cover letter should reference this job announcement, state your date of availability, introduce yourself, and provide your contact information to include name, phone, and e-mail address.