Description

Department of Health and Human Services (DHHS)

Food and Drug Administration (FDA)

Center for Devices and Radiological Health (CDRH)

Office of Communication, Information Disclosure, Training and Education (OCITE)

Office of Communication and Content Development (OCCD)

Division of Communication (DC)

Summary:

The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Communication Information Disclosure, Training and Education (OCITE) and being filled under FDA’s Title 21 hiring authority. This hiring authority was passed by Congress in December 2016, to improve FDA’s ability to recruit and retain scientific, technical, and professional experts in certain occupational series that “support the development, review, and regulation of medical products.” The FY23 Omnibus Appropriations Bill expanded the hiring authority to include cross-cutting positions and individuals that support the development, review, and regulation of food and cosmetics in addition to medical products. Both statutes amended the FD&C Act 21 USC. This hiring authority is a streamlined hiring authority, outlined in 21 USC 379d-3a, as amended by the 21st Century Cures Act of 2016, § 3072 and the Consolidated Appropriations Act of 2023, § 3624.

Learn More About This Agency:

Become a part of the Department that touches the lives of every American.
At the Department of Health and Human Services (HHS) you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective; that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe; and that all such products marketed in the U.S. are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated.

The mission of the Center for Devices and Radiologocal Health (CDRH) is to protect and promote public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH provides consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the United States.

CDRH’s Office of Communication, Information Disclosure, Training, and Education (OCITE) delivers clear, meaningful, science, and insights-based communication, education, and disclosures regarding medical devices and radiation-emitting products regulated by the Center. OCITE’s Office of Communication and Content Development (OCCD) provides strategic development and execution of internal and external communications, print and digital marketing content and materials, disclosure of information under the Freedom of Information Act (FOIA), and social science research that informs communication, training and education programs for the Center.  The Division of Communication (DC or CDRH Comms) provides strategic direction for and manages the development and release of internal and external communication regarding medical devices and radiation-emitting products for the Center. 

Title 21 Band D, GS-14/GS-15 equivalent

Minimum - $139,395.00

Maximum - $191,900.00

Salary: Salary is commensurate with education and experience and starts at $139,395.00

Overview

This job is open to:  Open to the Public

Hiring Path Clarification Text:  You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.

Duties

The Assistant Director (Supervisory Health Communications Specialist), assigned to the Division of Communication, focused on external communications, will oversee the following Teams:  Center Initiatives Content Development, Consumer Content Development, Industry Content Development, and Safety Content Development.  The incumbent also:

•        Collaborates in the development and implementation of the Division’s and Office’s integrated communications strategy, which will support programmatic goals, objectives, and initiatives.
•        Provides critical expertise, management, and oversight of multidisciplinary communications teams regarding a wide variety of communication activities and initiatives.
•        Manages the development and implementation of strategic plans, messaging, and associated public health and regulatory communication materials regarding regulated medical devices, products, and radiation-emitting diagnostic equipment.  
•        Supports the Division's and Office’s communication programs, research efforts, and findings to develop and deliver responsible and appropriate science-based public health information and messaging regarding the benefits and risks of medical devices, as well as the Center’s and Agency’s regulatory policies.
•        Provides expert advice, consultation, and technical assistance to Division and Office leadership in the planning and development of priorities, strategies, protocols, and practices for external communications related to medical devices, combination products, and radiation-emitting products.
•        Ensures the uniformed incorporation of research and advanced analytics into implementable communication programs and policies.
• Collaborates with Division and Office leadership to plan, organize, and establish or realign priorities, assignments, and work projects to advance new initiatives and the communication objectives of OCITE.
•        Write, edit, and collaborate with multimedia Officemates to disseminate a range of content and materials to include rollout plans and communication packages to support press releases, new initiatives and studies, responses to inquires, and other announcements related FDA regulated medical devices.
•        Collaborates with Division leadership to implement communication outreach goals, including publishing and managing Center specific content on FDA.gov,  Inside.FDA.gov, and digital content such as social media and external emails.
•        Ensures communication activities and materials are in compliance with the Agency’s diversity, equity, and inclusion policies.

Supervisory Responsibilities: 

The Assistant Director:

•        Manages and leads multidisciplinary communication teams responsible for delivering science-based public health information to diverse stakeholders and audiences, regarding FDA regulated medical devices.
•        Provides occupational specific technical and administrative direction to subordinate employees performing the work and functions of the organization.
•        Obtains resources and identifies strategic objectives for the organization, defines jobs, selects employees, and assigns work.
•        Defines technical work requirements and milestones.
•        Evaluates the organization and employee accomplishments by accepting or rejecting work products.

Conditions of Employment:

•        U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
•        The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
•        Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
•        FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
•        Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information.
•        One-year probationary period may be required.
•        One-year supervisory probationary period may be required.
•        Financial Disclosure may be required.
•        Ethics Clearance may be required.
•        Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
•        Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
•        Applicants must meet all qualification requirements by the closing date of this announcement.
•        Must verify U.S. Citizenship in application email. Self-Declaration is acceptable.

Qualifications

Minimum Years of Experience is the new standard, rather than specialized experience, for determining and validating a Title 21 candidate’s band. This standard applies across all Title 21 positions. 

Minimum Years of Experience required for Band D:

• Bachelor’s – 5 Years
• Master’s – 4 Years
• Doctorate and/ or JD – 3 Years
• No qualifying degree – 7 Years

In order to qualify for a Supervisory Health Communications Specialist/Assistant Director, AD-1001, you must meet the following requirements:

Basic Qualification Requirements:

To qualify for this position, candidates must possess technical experience and expertise, which includes:

•        Expert knowledge of communication best practices and the ability to advise Division and Office leadership of the strategies and programs designed to foster evidenced-based, informative, and  transparent communication with internal and external stakeholders, as well as the general public, regarding the benefits and risks of FDA-regulated medical devices, products, and radiation-emitting diagnostic equipment.
•        Experience in overseeing the development and conducting the reviews of communication materials and applying strategies using traditional and digital communication approaches to disseminate essential science-based regulatory and public health information to patients, health professionals, industry, media, and the general public.
•        Ability to manage and oversee quickly evolving public health communication activities or programs for scientific, healthcare focused, or regulatory organization.
•        Experience in consolidating and balancing resource needs of multiple initiatives and projects across a complex and diverse scientific, healthcare, or regulatory organization.
•        Ability to skillfully engage and collaborate with diverse stakeholders to address organizational communication needs.
•        Knowledge of organizational, operational, and programmatic concepts and practices applied by public, private, or nonprofit agencies and organizations engaged in public health or other health-related activities.
•        Knowledge of the methods, processes, and techniques used to develop and deliver public health or health-related information and/ or programs.
•        Knowledge of, and skill in, the application of administrative or analytical methods and techniques necessary for working within the framework of a public health or related organization and carrying out specific program functions.
•        Skill in oral and written communications, gathering and conveying information, making oral presentations, and preparing reports, correspondence, and other written materials.
•        Knowledge of health and risk communication concepts and principles.

Desired Professional Experience: 

•        Ability to manage competing priorities under strict deadlines while maintaining a high level of attention to detail.
•        Ability to plan, set goals, and determine strategies for accomplishing results, as well as monitor, evaluate and report on progress towards goals.
•        Ability to build relationships with multiple teams to support Division and Office cross collaboration.
•        Ability to recognize potential communication challenges and develop solutions based on best practices and research.
•        Expertise in developing, writing, and editing complex public health, regulatory, and scientific communication materials.

How to Apply

Submit resume or curriculum vitae, cover letter containing a brief summary of  accomplishments, SF-50 (if applicable), and a copy of unofficial transcripts in one combined document (Adobe PDF) to CDRHRecruitment@fda.hhs.gov, with Job Reference code “2024 - OCITE – Assistant Director/Supervisory Health Communications Specialist in the subject line. Applications will be accepted through Friday, December 15, 2024.

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply to this announcement. Officers must follow the instructions for how to apply and include their most recent orders in addition to the required documents. If selected, candidates will be referred to (CC) personnel and not as candidates for a Cures appointment.

Additional Conditions of Employment:

•        Pre-employment physical required: No
•        Drug testing required: No
•        License Required: No
•        Mobility agreement required: No
•        Immunization required: No
•        Bargaining Unit: 8888
•        Telework eligible position: This position is remote
•        Incentives Authorized: No
•        Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.
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This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.

Additional Information:

       If you are serving, or have served in the last 5 years (from 12/01/2023) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of

Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more.

All requirements must be met by the closing date of this announcement, December 15, 2024; only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

How you will be Evaluated:

You will be evaluated for this job based on how well you meet the qualifications above.

This is a Title 21 announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. You will be evaluated against the basic qualifications and if found qualified, you will be referred to the Hiring Manager for consideration.

If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test.

Failure to comply with any of the additional assessment requirements will result in removal from further consideration.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Announcement Contact

For questions regarding this Cures position, please contact CDRHRecruitment@fda.hhs.gov.

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

FDA is an equal opportunity employer.