FDA Global Generic Drug Regulatory Research Fellowship
Oak Ridge Institute for Science and Education · Silver Spring, MD · 1 mo ago
LegalContract
We need to output HTML fragment with sections only if real content. Use for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We need to extract content from posting.
First, remove boilerplate: navigation, cookie, legal, EEO, etc. The posting includes many sections: Organization, Reference Code, How To Apply, Application Deadline, Description, etc.
We need to preserve substantive info: description of role, responsibilities, learning objectives, mentor, start date, appointment length, level of participation, stipend (but note "commensurate with educational level and experience" - that is vague; we should NOT create Pay section unless posting actually states them. The stipend is described as "commensurate with educational level and experience." That's vague; we should not create Pay section because it's not specific. Similarly Benefits: "Participants do not become employees... there are no employment-related benefits." That's not a benefit; we should not create Benefits section unless actual benefits stated. There's mention of proof of health insurance required, but that's a requirement not a benefit. So we likely will not include Benefits, Pay, Schedule sections unless specific.
Schedule: "Level of Participation: The appointment is full time." That's schedule info (full time). Could we create Schedule section? The rule: include a section ONLY when posting has real, specific content for it. "Full time" is specific enough? It's not vague like "varies". So we could include Schedule section with that content.
Pay: stipend is vague; we should not include Pay.
Benefits: no specific benefits; we should not include Benefits.
Now sections:
About the role: could be description of the opportunity: research project, learning objectives, etc. We'll put that under About the role.
Responsibilities: maybe the learning objectives and activities: engage in interdisciplinary research and training activities, etc. Could be under Responsibilities.
Requirements: maybe citizenship requirements, proof of health insurance, background investigation, etc.
Qualifications: degree requirements, etc.
Skills: preferred skills.
We need to avoid repeating job title as heading (not present). Also no Job ID/requisition numbers as headings; we can fold reference code into a short p.
We must preserve all substantive information; do not invent or summarize away detail.
We need to output only HTML fragment.
Let's extract substantive content:
- Organization: U.S. Food and Drug Administration (FDA) - maybe not needed as heading but could be in About the role paragraph.
- Reference Code: FDA-CDER-2026-0143
- How To Apply: instructions to scroll bottom and click APPLY, etc. But we must remove application instructions per rule: "Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions." So we should remove How To Apply section entirely.
- Application Deadline: 8/31/2027 12:00:00 AM Eastern Time Zone. This is substantive; could be placed maybe under About the role or a separate section? There's no specific heading for deadline; we could include it in a paragraph under About the role or maybe under a generic heading? But we only allowed headings list; we could put it in About the role paragraph.
- Description: includes FDA Office and Location, research project details, learning objectives, mentor, start date, appointment length, level of participation, stipend, citizenship requirements, health insurance proof, background investigation, etc.
- Qualifications: degree requirements, etc.
- Preferred Skills: list.
- Affirmation: statement about US citizen or lived in US 36 months.
We need to preserve all substantive info; we must not discard things like reference code, deadline, location, mentor, start date, appointment length, level of participation, stipend (though vague), citizenship requirements, health insurance proof, background investigation, qualifications, skills, affirmation.
We need to format into sections.
Let's decide sections:
About the role: include organization, location, research project description, learning objectives (maybe as bullet list), mentor, start date, appointment length, level of participation, stipend (maybe mention it's commensurate), deadline, reference code.
Responsibilities: maybe the activities: engage in interdisciplinary research and training activities related to regulatory science, including exploration of analytical chemistry, pharmacokinetics, manufacturing sciences, regulatory policy, global harmonization concepts; educational exposure to generic drug user fee program planning, workflow analysis, process documentation, knowledge management approaches.
Requirements: citizenship requirements (US citizens, LPR, foreign nationals with guidelines), proof of health insurance required, background investigation requirement (OPM can complete only for individuals who have resided in US for total of three of past five years). Also maybe the affirmation statement.
Qualifications: degree requirement: bachelor's or higher in relevant fields received within past five years or currently pursuing.
Skills: preferred skills list: ability to identify and analyze problems; weigh relevance and accuracy; generate alternative solutions; make recommendations; experience assessing information/data related to drug products; skills in verbal communications to present convey information related to wide range of pharmaceutical issues, interact with colleagues; ability to effectively communicate in varying writing formats to broad audiences.
We could also include the affirmation under Requirements or a separate section? Not in headings list; we could put under Requirements.
We must not create sections with filler text. Ensure each section has substantive content.
Now produce HTML:
Skills:
for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We need to extract content from posting.
First, remove boilerplate: navigation, cookie, legal, EEO, etc. The posting includes many sections: Organization, Reference Code, How To Apply, Application Deadline, Description, etc.
We need to preserve substantive info: description of role, responsibilities, learning objectives, mentor, start date, appointment length, level of participation, stipend (but note "commensurate with educational level and experience" - that is vague; we should NOT create Pay section unless posting actually states them. The stipend is described as "commensurate with educational level and experience." That's vague; we should not create Pay section because it's not specific. Similarly Benefits: "Participants do not become employees... there are no employment-related benefits." That's not a benefit; we should not create Benefits section unless actual benefits stated. There's mention of proof of health insurance required, but that's a requirement not a benefit. So we likely will not include Benefits, Pay, Schedule sections unless specific.
Schedule: "Level of Participation: The appointment is full time." That's schedule info (full time). Could we create Schedule section? The rule: include a section ONLY when posting has real, specific content for it. "Full time" is specific enough? It's not vague like "varies". So we could include Schedule section with that content.
Pay: stipend is vague; we should not include Pay.
Benefits: no specific benefits; we should not include Benefits.
Now sections:
About the role: could be description of the opportunity: research project, learning objectives, etc. We'll put that under About the role.
Responsibilities: maybe the learning objectives and activities: engage in interdisciplinary research and training activities, etc. Could be under Responsibilities.
Requirements: maybe citizenship requirements, proof of health insurance, background investigation, etc.
Qualifications: degree requirements, etc.
Skills: preferred skills.
We need to avoid repeating job title as heading (not present). Also no Job ID/requisition numbers as headings; we can fold reference code into a short p.
We must preserve all substantive information; do not invent or summarize away detail.
We need to output only HTML fragment.
Let's extract substantive content:
- Organization: U.S. Food and Drug Administration (FDA) - maybe not needed as heading but could be in About the role paragraph.
- Reference Code: FDA-CDER-2026-0143
- How To Apply: instructions to scroll bottom and click APPLY, etc. But we must remove application instructions per rule: "Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions." So we should remove How To Apply section entirely.
- Application Deadline: 8/31/2027 12:00:00 AM Eastern Time Zone. This is substantive; could be placed maybe under About the role or a separate section? There's no specific heading for deadline; we could include it in a paragraph under About the role or maybe under a generic heading? But we only allowed headings list; we could put it in About the role paragraph.
- Description: includes FDA Office and Location, research project details, learning objectives, mentor, start date, appointment length, level of participation, stipend, citizenship requirements, health insurance proof, background investigation, etc.
- Qualifications: degree requirements, etc.
- Preferred Skills: list.
- Affirmation: statement about US citizen or lived in US 36 months.
We need to preserve all substantive info; we must not discard things like reference code, deadline, location, mentor, start date, appointment length, level of participation, stipend (though vague), citizenship requirements, health insurance proof, background investigation, qualifications, skills, affirmation.
We need to format into sections.
Let's decide sections:
About the role: include organization, location, research project description, learning objectives (maybe as bullet list), mentor, start date, appointment length, level of participation, stipend (maybe mention it's commensurate), deadline, reference code.
Responsibilities: maybe the activities: engage in interdisciplinary research and training activities related to regulatory science, including exploration of analytical chemistry, pharmacokinetics, manufacturing sciences, regulatory policy, global harmonization concepts; educational exposure to generic drug user fee program planning, workflow analysis, process documentation, knowledge management approaches.
Requirements: citizenship requirements (US citizens, LPR, foreign nationals with guidelines), proof of health insurance required, background investigation requirement (OPM can complete only for individuals who have resided in US for total of three of past five years). Also maybe the affirmation statement.
Qualifications: degree requirement: bachelor's or higher in relevant fields received within past five years or currently pursuing.
Skills: preferred skills list: ability to identify and analyze problems; weigh relevance and accuracy; generate alternative solutions; make recommendations; experience assessing information/data related to drug products; skills in verbal communications to present convey information related to wide range of pharmaceutical issues, interact with colleagues; ability to effectively communicate in varying writing formats to broad audiences.
We could also include the affirmation under Requirements or a separate section? Not in headings list; we could put under Requirements.
We must not create sections with filler text. Ensure each section has substantive content.
Now produce HTML:
About the role
...
Then maybeResponsibilities
- ...
Requirements
- ...
Qualifications
...
Skills: Skills
- ...
Schedule: Schedule
The appointment is full time.
We should not include Benefits, Pay. Check if any content duplicated: we must not repeat. Let's craft paragraphs. About the role paragraph: include organization, location, reference code, deadline, description of research project, learning objectives (maybe as bullet list? but we could keep as prose). However we have separate Responsibilities for activities; learning objectives could be under About the role or Responsibilities. To avoid duplication, we can put learning objectives under About the role as bullet list? But we already have Responsibilities for activities; learning objectives are more about what you will gain. Could be under About the role. Let's decide: About the role: overview: FDA Office of Generic Drugs (OGD) research opportunity, location Silver Spring, MD, reference code, deadline, brief description of project. Responsibilities: list of activities: engage in interdisciplinary research and training activities related to regulatory science (analytical chemistry, pharmacokinetics, manufacturing sciences, regulatory policy, global harmonization); educational exposure to generic drug user fee program planning, workflow analysis, process documentation, knowledge management approaches. Requirements: citizenship, health insurance proof, background investigation, affirmation. Qualifications: degree requirement. Skills: preferred skills list. Schedule: full time. Now ensure we preserve all specifics: - Mentor: Darby Kozak (Darby.Kozak@fda.hhs.gov). Should be included somewhere; maybe About the role. - Anticipated Appointment Start Date: September 21, 2026. Start date flexible. - Appointment Length: initially one year, may be renewed upon recommendation and contingent on funds. - Level of Participation: full time. - Participant Stipend: monthly stipend commensurate with educational level and experience. (We may mention but not create Pay section.) - Citizenship Requirements: opportunity available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to Guidelines for Non-U.S. Citizens Details page for valid immigration statuses. - Proof of health insurance required. - Background investigation: Completion of a successful background investigation by OPM required; OPM can complete only for individuals, including non-US Citizens, who have resided in US for total of three of past five years. - Affirmation: I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.) - Qualifications: The qualified candidate should have received, or currently be pursuing, a bachelor's degree or higher in one of the relevant fields. Degree must have been received within the past five years. - Preferred Skills list as given. Now we need to ensure we don't include boilerplate like "Connect with ORISE...on the GO! Download the new ORISE GO mobile app..." etc. Remove. Also remove "Application Deadline 8/31/2027 12:00:00 AM Eastern Time Zone" we keep. Now craft HTML. We'll need to escape any HTML special characters? Not needed. Let's write:About the role
Opportunity with the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) in Silver Spring, Maryland. Reference code: FDA-CDER-2026-0143. Application deadline: August 31, 2027, 12:00 AM Eastern Time. This mentored learning experience focuses on the evolving global landscape of generic drug regulation, manufacturing, and supply chain dynamics, including comparative evaluation of international regulatory frameworks, bioequivalence approaches, and scientific considerations influencing generic drug quality, access, development pathways, and approval timelines. You will engage in interdisciplinary research and training activities related to regulatory science, including exploration of analytical chemistry, pharmacokinetics, manufacturing sciences, regulatory policy, and global harmonization concepts under the guidance of FDA scientists and subject matter experts. The opportunity also includes educational exposure to generic drug user fee program planning, workflow analysis, process documentation, and knowledge management approaches. Mentor: Darby Kozak (Darby.Kozak@fda.hhs.gov). Anticipated appointment start date: September 21, 2026 (flexible). Initial appointment length: one year, renewable upon recommendation and contingent on funding.
Now Responsibilities:Responsibilities
- Engage in interdisciplinary research and training activities related to regulatory science, including exploration of analytical chemistry, pharmacokinetics, manufacturing sciences, regulatory policy, and global harmonization concepts.
- Gain educational exposure to generic drug user fee program planning, workflow analysis, process documentation, and knowledge management approaches.
- Participate in mentored training activities involving scientific literature evaluation, comparative regulatory analysis, workflow and process mapping, technical documentation review, and examination of knowledge management approaches relevant to generic drug programs.
- Integrate scientific, regulatory, and policy perspectives through engagement with multidisciplinary subject matter experts in areas such as pharmacokinetics, analytical chemistry, manufacturing sciences, regulatory policy, and global harmonization.