11 days old

Sr. Advisor Medical Countermeasures Coordinator

Nationwide
  • Job Type
    Employee
  • Job Status
    Full Time

The Senior Advisor serves as the ORA authority with medical countermeasures (MCM) and advanced medical products manufacturing. Recommends operational policy relating to domestic and international program area through the preparation of opinion papers and providing advice and counsel to ORA management corresponding to the specialty area. Additionally, the senior advisor:
• Leads cross-cutting project coordination efforts for enterprise-wide entities as they pertain to agency-level inspectional activities and operational standards across all commodities.
• Collaborates effectively and coordinates throughout ORA and with external partners and stakeholders to gather input, develop recommendations for efficiencies in current work processes and implement changes; maintains appropriate and constructive relationships with Program offices and other components of FDA headquarters; and coordinates with Center compliance, technical and scientific staff to understand technical and regulatory issues with advanced manufacturing to ensure inspectional activities and operational policy keeps pace with industry advancements
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• In collaboration with FDA’s MCM agency leads, DHHS components and other government agencies:
o Enhance communications and partnerships with external stakeholders in addressing global supply chain issues.
o Ensures ORA’s priorities are aligned and reflected in the overall advancement of modern, emerging, and advance technology through proactive and sustained collaboration.
• Coordinating with ORA Senior Emergency Response Coordinators (ERCs) and product centers on medical countermeasures preparedness and response activities
• Evaluates a broad range of issues concerning implementing legislation, regulations, policies and/or procedures affecting medical products programs and makes recommendations to the Associate Director for Advanced Medical Products.
• Monitoring emerging threats and data to identify resource needs and gauge Agency preparedness / response level.
• Representing the Agency at executive level meetings and serving as an authority on MCM subject matter
• Evaluates, develops, and maintains the ORA MCM training program, including new MCM priorities and initiatives, in consultation with management and development coordinator.
• Collaborate with OMPTO programs, Office of Training, Education, and Development (OTED), Centers, and Office of Counterterrorism Emerging Threats (OCET) to develop and execute MCM training and preparedness exercises.
• Participates in course advisory groups and/or curriculum committees and acts as training instructor, as appropriate.
• Acts as a liaison with other government agencies, industry groups and professional organizations to evaluate and leverage training expertise from outside FDA.
• Working with ORA/Center POCs s to ensure the development and implementation of standardized MCM procedures throughout agency.
The senior advisor is a field resource in inspections/investigations of the commodities regulated by the FDA. The incumbent serves as an advisor for Advanced Medical Product Manufacturing and ORA Management in the formulation of program goals, objectives and broad operating policies covering the full scope of specialized programs and activities related to medical products regulated by the agency. Provides professional and managerial expertise and leadership in the development and enhancement ORA field science-based regulatory surveillance and compliance programs that support FDA and ORA regulatory compliance goals and participates as a key member of OMPTO’s management team in the development of long-range strategic and operational plans, complex cross cutting information collection and analysis and decision-making.

Requirements

U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required
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documents, and any other job-related requirement before or after appointment. • Applicants must meet all qualification requirements by the closing date of this announcement.
• 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.
• One-year probationary period may be required.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Background Investigation/Security Clearance is required. 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.
Qualifications
To be placed into a Cures position, candidates must meet the following criteria:
1. Scientific, Technical, and Professional Fields
2. Qualified and Outstanding Candidates
a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
b. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.
In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.
Education Requirement: The education must have been obtained at a college, university, or an
accrediting body recognized by the Secretary, U.S. Department of Education at the time the
degree was obtained. For more information please see: OPM Occupational Series Qualification Requirements
Consumer Safety Officer Series 0696
Professional Experience:
• Mastery of the principles, theories and practices related to advanced manufacturing including regulatory.
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• Knowledge of the principles, theories, and practices of related scientific or professional fields that enable the incumbent to carryout tasks related to regulatory activities in medical devices and radiological health products.
• Mastery of inspectional and investigative techniques associated with the regulation of the domestic and international industries within the medical products device and radiological health and advanced manufacturing technologies functional program area.
• Comprehensive knowledge of the FD&C Act and regulations, related acts, laws legislation and precedents, that govern the procedures and guidance materials of ORA and associated organizations.
• Thorough knowledge of the principles and practices of manufacturing technologies in medical devices and radiological products health to serve as a technical authority on current and emerging technologies to provide authoritative advice and assistance to other senior technical experts on extensive and complicated manufacturing processes and operations and training opportunities.
• Mastery of legislation, laws, precedents, and regulations which govern ORA’s activities related to Medical Device and Radiological Health Products to serve as a technical authority to interpret and provide advice on all related policies and develop new or revised existing approaches, precedents, and methods.
• Skill in oral and written communications to make clear, convincing presentations; represent the Agency at meetings and conferences; interact with high level officials and representatives from public and private public health organizations.
• Mastery of a wide range of advanced manufacturing and novel product technologies and qualitative and quantitative analytical methods and techniques to provide the Office Program Directors, ACMPTO and other senior staff of ORA with authoritative information, analyses, advice, and assistance in the formulation and solution of major, complex, and sensitive issues, emerging threats and problems which face ORA.

Categories

Posted: 2022-11-15 Expires: 2022-12-15

FDA Office of Regulatory Affairs

FDA’s Office of Regulatory Affairs (ORA) is the lead office for all agency regulatory activities. Over 5,000 ORA employees strategically located in district offices, resident posts, and laboratories throughout the United States perform inspections and investigations (including criminal investigations), wharf exams, sample collections and analyses, and carry out enforcement activities, education, and outreach directly to consumers, industry representatives, importers, and shippers as well as other stakeholders across the nation. ORA also works with its federal, state, local, tribal, territorial, and foreign counterparts to further the agency’s mission. ORA is led by the Associate Commissioner for Regulatory Affairs (ACRA).

To view our ORA Vision, Mission, and Values please visit: https://www.fda.gov/about-fda/office-regulatory-affairs/ora-vision-mission-and-values

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Sr. Advisor Medical Countermeasures Coordinator

FDA Office of Regulatory Affairs
Nationwide

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