About the Position: The U.S. Army Medical Research and Development Command (USAMRDC) is a major subordinate command of the U.S. Army Futures Command. Our vision is to be a trusted partner for leading biomedical research and materiel innovation for global health. USAMRDC's world-class reputation is the direct result of the outstanding leadership, work ethic, and selfless service of its highly talented workforce. Please visit our website https://mrdc.health.mil

Duties

Provides leadership and direction for the Office of Regulated Activities (ORA) Regulatory Branch Provides expertise to others within the branch and throughout ORA as a Subject Matter Expert Support essential regulatory, clinical, and quality support to ORA partners/stakeholders Develop regulatory strategies and processes to integrate regulatory support into the medical product development acquisition life-cycle from the discovery/pre-clinical stage to Food and Drug Administration (FDA) approval Performs supervisory duties for civilian personnel in the Regulatory Branch Provide leadership to Branch staff serving as subject matter experts in FDA regulated medical research and development programs Develop branch resourcing plans and budgets in coordination with ORA leadership and ORA Business Office to support work of the branch Ensure compliance to requirements for FDA regulated research and development in accordance with applicable Code of Federal Regulations (CFR), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) Develop and apply regulatory affairs standard operating procedures, policies, and guidance documents Educates researchers and advanced developers regarding FDA regulatory requirements Maintains Branch awareness on changes in FDA regulations, policies, and guidance Provide strategic regulatory intelligence impacting Department of Defense medical product developmental efforts Acts as Regulatory Branch POC for formal and informal interactions and meetings with the FDA Provide management/oversight of teams providing consultative support for FDA regulated activities to ORA partners and stakeholders Interacts with study sponsors, project managers, clinical research staff and the Food and Drug Administration (FDA) to provide timely preparation, review, and submission of FDA premarket and postmarket regulatory submissions Manages multifunctional submissions teams responsible for the overall process of regulatory submissions

Requirements

• Appointment may be subject to a suitability or fitness determination, as determined by a completed background investigation.
• This position requires submission of Financial Disclosure Statement, OGE-450 upon entering the position and annually thereafter.
• Business Travel Required up to 25% of the Time
• Obtain and Maintain Secret Security Clearance
• Three Year Probationary Period Required
• One Year Supervisory Probationary Period Required
• Selectees must meet position requirements for certification at Level Practitioner in the Acquisition Career Field Engineering and Technical Management within 60 Months of Entrance on Duty
• This position requires a 3-year tenure agreement. Incumbent must sign DD Form 2888 (Critical Acquisition Position Service Agreement) and execute, as a condition of employment, a written tenure agreement.

Qualifications

This is a re-announcement. Those applicants whom applied to announcement number NEBB236814949158, MUST re-apply. Who May Apply: Only applicants who meet one of the employment authority categories below are eligible to apply for this job. You will be asked to identify which category or categories you meet, and to provide documents which prove you meet the category or categories you selected. See Proof of Eligibility for an extensive list of document requirements for all employment authorities. Current Department of Army Civilian EmployeesCurrent Department of Defense (DOD) Civilian Employee (non-Army)Current Term United States Army Medical Research and Development Command EmployeeDomestic Defense Industrial Base/Major Range and Test Facilities Base Civilian Personnel WorkforceInteragency Career Transition Assistance PlanLand Management Workforce Flexibility ActMilitary Spouses, under Executive Order (E.O.) 13473Non-Department of Defense (DoD) TransferPriority Placement Program, DoD Military Spouse Preference (MSP) EligibleReinstatementVeterans Employment Opportunity Act (VEOA) of 1998 The U.S. Army Medical Research and Development Command (USAMRDC) is participating in an alternative personnel system known as the Personnel Demonstration Project (PDP). The DB-03 payband is equivalent to the GS-13 step 1 to GS-14 step 10 level. In keeping with the Demonstration pay fixing policies, employees earning a salary that falls within this payband equivalent, may not receive an immediate pay increase (promotion) if appointed to this position. Future pay increases within the payband will be accomplished through the pay for performance management system. This position is scheduled to transfer to the Defense Health Agency (DHA) in accordance with the provisions of Section 702 of the National Defense Authorization Act for Fiscal Year 2017, Public Law 114-328. Employees will become DoD employees upon transfer to the DHA. In order to qualify, you must meet the education and experience requirements described below. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). You will receive credit for all qualifying experience, including volunteer experience. Your resume must clearly describe your relevant experience; if qualifying based on education, your transcripts will be required as part of your application. Additional information about transcripts is in this document. Basic Requirement for Regulatory Branch Chief: Degree: Bachelor's or graduate (or higher level) degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program accredited by an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. You MUST submit copies of your transcripts supporting your education In addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements listed below: Specialized Experience: One year of specialized experience which includes: (1) Experience performing or assisting with regulatory quality assurance monitoring of new biological, pharmaceutical and medical device products. (2) Experience maintaining a regulatory framework in accordance with Food and Drug Administration (FDA) regulations, and Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and/or Good Manufacturing Practice (GMP) regulatory requirements. (3) Experience interacting with varied groups and types of internal and external stakeholders to provide regulatory support across FDA regulated research and development efforts. This definition of specialized experience is typical of work performed at the next lower grade/level position in the federal service (DB-02 / GS-12). You will be evaluated on the basis of your level of competency in the following areas: CommunicationsCompliancePlanning and Evaluating

Education

Some federal jobs allow you to substitute your education for the required experience in order to qualify. For this job, you must meet the qualification requirement using experience alone--no substitution of education for experience is permitted.

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.

Contacts

• Address BB-APF-W03JAA USA MED RESEARCH AND DEV CMD DO NOT MAIL Frederick, MD 21702 US
• Name: Army Applicant Help Desk