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FDA Public Health and Regulatory Research Fellowship

Organization

Oak Ridge Institute for Science and Education, Silver Spring, Maryland

About the position

*Applications will be reviewed on a rolling-basis, and this opportunity will remain open until filled.

A research opportunity is currently available with the U.S. Food and Drug Administration (FDA), Office of Public Health, Strategy, and Analysis (PHSA), under the Office of the Commissioner (OC), located in Silver Spring, Maryland.

Under the guidance of a mentor, the fellow will be trained on research projects to provide evidence to inform FDA’s public health policy priorities. The fellow will be assigned to quantitative and qualitative research projects related to FDA’s domestic and/or global regulatory research in the generic drug space. In addition to the mentor, the fellow will be trained closely by subject matter experts across the FDA to accomplish project goals. Potential projects include (but are not limited to) research and analysis of:

• Generic drug approvals and market competition
• FDA’s foreign inspections of generic drug manufacturers
• The quality of drug marketing applications submitted to the FDA

While at the FDA, the fellow will have additional learning opportunities such as attending workshops, professional conferences, high-level policy meetings with the director, staff, and FDA senior leadership as well as the opportunity to learn from other PHSA research, and to explore other parts of FDA.

Anticipated Appointment Start Date: June 1, 2024.

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

FDA Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:

• Non-employee nature of the ORISE appointment;
• Prohibition on ORISE Fellows performing inherently governmental functions;
• Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
• The fact that research materials and laboratory notebooks are the property of the FDA;
• ORISE fellow’s obligation to protect and not to further disclose or use non-public information.

Apply for this vacancy

What you'll need to apply

A complete application consists of:

• An application
• Transcripts – Click here for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• One educational or professional recommendation
• All documents must be in English or include an official English translation.

Contact name

Contact email

[email protected]

Qualifications

The qualified candidate should have received or be currently pursuing a master's degree in one of the relevant fields. Degree must have been received within the past five years, or be currently pursuing.

Preferred skills:

• Experience in quantitative research (data collection, secondary data analysis, mathematical modeling, etc.) is highly desired; as well as a demonstrated ability to research independently.

Disclaimer/Fine Print

The application must be completed through Zintellect. https://www.zintellect.com/Opportunity/Details/FDA-OC-2024-0001

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Qualitative Research Associate

🔍 graduate school of education, stanford, california, united states.

Minimum Requirements:

Education and Experience:  Advanced degree and five years of relevant experience in area of specialization or combination of relevant education, training, and/or experience. For jobs with financial responsibilities, experience managing a budget and developing financial plans. Experience developing program partnerships and funding sources.

Education and Experience Preferred:  A doctorate (or equivalent) in a relevant field (education, public policy, sociology, anthropology, psychology, or related field) is required as is capacity to oversee graduate students as they design, carry out, and write about their research projects. 

Knowledge, Skills, and Abilities:

• Ability to develop program partnerships and funding sources.
• Advanced oral, written, and analytical skills, exhibiting fluency in area of specialization.
• Ability to oversee and direct staff.
• Ability to manage budgets and develop financial plans.

Knowledge, Skills, and Abilities Preferred:

Experience with qualitative data collection and analysis is required.  Demonstrated experience with designing qualitative studies is required, as is proficiency with data analysis software such as NVIVO. Excellent oral, analytic, organizational, and interpersonal skills are required; writing as demonstrated in the candidate’s own writing and publications is essential.  Ability to write for multiple audiences, including policy makers and practitioners, is preferred. The candidate must have strong interpersonal and collaboration skills in working with researchers and practitioners as well as organizational skills that demonstrate their ability to handle multiple tasks, timelines and priorities in a team environment.  Familiarity with California K-12 education context, and English language learners is preferred.  This may be substituted with familiarity with juvenile justice, mental health or foster care systems or a related youth policy issue. Familiarity with school enrichment and youth development programs, such as after-school programs is a plus.

Certifications and Licenses:

• For teaching jobs, advanced degree or certification may be required for some programs.

Why Stanford is for You

We provide market competitive salaries, excellent health care and retirement plans, and a generous vacation policy, including additional time off during our winter closure. Our unique perks align with what matters to you:

• Freedom to grow. As one of the greatest intellectual hubs in the world, take advantage of development programs, tuition reimbursement plus $800 you receive annually towards skill-building classes, or audit a Stanford course. Join a TedTalk, film screening, or listen to a renowned author or leader discuss global issues.
• A caring culture. We understand the importance of your personal and family time and provide you access to wellness programs, child-care resources, parent education and consultation, elder care and caregiving support.
• A healthier you. We make wellness a priority by providing access to world-class exercise facilities. Climb our rock wall, or participate in one of hundreds of health or fitness classes.
• Discovery and fun. Stroll through historic sculptures, trails, and museums. Create an avatar and participate in virtual reality adventures or join one with fellow staff on Stanford vacations!
• Enviable resources. We offer free commuter programs and ridesharing incentives. Enjoy discounts for computing, cell phones, outdoor recreation, travel, entertainment, and more!

We pride ourselves in being a culture that encourages and empowers you.  

How to Apply: We invite you to apply for this position by clicking on the “Apply for Job” button. To be considered, you must submit a cover letter and résumé along with your online application.

• Finalist must successfully complete a background check prior to working at Stanford University. 
• This is a fixed-term position with an end date of one year and is renewable based on performance and funding
• Applicants to this position must be available to work in the United States without sponsorship for 2 years or more. OPT permit holders should confirm that they are eligible to work in the US at the Stanford GSE for two years or more

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

• Schedule: Full-time
• Job Code: 4113
• Employee Status: Fixed-Term
• Requisition ID: 92105

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