Research Associate - Board on Health Sciences Policy
6 days left
- Full Time
The Health and Medicine Division (HMD) is a division of the National Academies of Sciences, Engineering, and Medicine (The National Academies). HMD's aim is to help those in government and the private sector make informed health decisions by providing evidence upon which they can rely. HMD previously was the Institute of Medicine (IOM) program unit of the National Academies. On March 15, 2016, the division was renamed HMD, building on the heritage of the IOM's work in medicine while emphasizing its increased focus on a wider range of health matters.
The Board on Health Sciences Policy oversees and guides a program of activities that is intended to encourage and sustain the continuous vigor of the basic biomedical and clinical research enterprises needed to ensure and improve the health and resilience of the public. In conducting these activities, consideration is given to the ethical, legal, and social contexts of scientific and technologic advances and to the balance between scientific opportunities and public needs.
DRUG COMPOUNDING CONSENSUS STUDY DESCRIPTIONS
The National Academies will conduct a study to examine the clinical utility of treating patients with compounded bioidentical hormone replacement therapy (BHRT) products. Compounded BHRT products, such as progesterone and testosterone, are used at times instead of FDA-approved drug products for hormone replacement therapy. Some compounders market BHRT products as superior to FDA-approved drugs by making assertions that they are more natural or safer or better for patients than FDA-approved drug products. However, compounded BHRT products are not FDA-approved, which means these products have not undergone an FDA assessment of quality, safety, effectiveness and bioavailability (the extent and rate at which the drug enters the body).
The National Academies will conduct a study to examine available evidence of the safety and effectiveness of multi-ingredient compounded topical pain creams. These creams typically contain multiple active pharmaceutical ingredients (APIs). Often at least one of the ingredients is also found in an FDA-approved topical pain cream, such as lidocaine. However, the remaining ingredients may be active ingredients in drugs approved by FDA for non-topical administration and for non-pain-related indications. FDA is aware of adverse events, ranging from skin reactions to death, in patients who have applied compounded topical pain creams.
Develops pertinent background research which contributes to a greater understanding of conditions, issues and trends impacting assigned program(s) or project(s), subjects and topics. Drafts background papers. Prepares preliminary outlines of projects to determine appropriate methodology, which may involve developing an historical perspective; identifying prevailing social and economic conditions, outlining legislative considerations; regulatory impact; international involvement in issues; and future trends and implications. Performs research and analysis. Documents and establishes files on all statistical analyses performed. Prepares data for use in summaries, fact sheets, and reports. Edits report material developed by committee members, senior staff, and consultants. Responds to inquiries about study activities and increases public awareness of studies. Manages related databases, including reference databases. May assist with administrative duties related to programs/projects.
The job's primary focus may be supporting studies or convening activities relating to the safety, efficacy, and clinical utility of compounded drug products (e.g. compounded bioidentical hormone replacement therapy; compounded topical pain cream). Applying general professional level knowledge and principals of research, incumbent performs duties requiring the identification and analysis of various factors and independent judgment and discretion to recommend best course of action. Incumbent proceeds on own initiative in compliance with policies, procedures, and practices, but receives guidance or expertise from supervisor or higher-level staff when needed. May lead and/or supervise lower level support employees.
ESSENTIAL JOB DUTIES:
1. Develops information sources. Reads, analyzes, and evaluates data and literature. Prepares preliminary outlines of projects to determine appropriate methodology. Conducts discussions with various officials, academics, allied groups and staff. Analyzes data developed and prepares written interpretations. Synthesizes data for specific sections of the report or other types of output. Verifies references and checks facts of committee reports.
2. Performs research and analysis, analyzing and organizing technical data and reports and compiling summaries of information. May perform basic statistical research and analysis. Prepares and formats various survey instruments and databases to accept specified information.
3. Manages database to track references. Manages and maintains bibliographic and analytical databases. Documents and establishes files on all statistical analyses performed indicating methodology, variations in manipulation of data and resource materials used.
4. Writes technical papers or summaries. Abstracts information from scientific studies to create tables for committee review or use in committee reports. Drafts, summarizes, and edits findings and provides feedback to appropriate parties.
5. May ensure Federal Advisory Committee Act, (FACA) and Governing Board Executive Committee (GBEC) compliance. Ensures Current Projects System (CPS) is posted and updated in a timely manner, the Public Access File is maintained, and documents are properly archived.
6. Participates in selecting literature for committee members, forum and workshop participants, and other applicable groups to receive through mailings, briefing books, and meetings. Attends meetings to present and receive feedback regarding study area and prepares meeting summaries.
7. Prepares the report for review and assists with review response. Ensures edits are included in the report. Creates bibliographies, graphics, and tables for reports.
8. Responds to inquiries from the public sector, sponsors and other scientific peers outside of the National Academies. Increases public awareness of studies. Identifies and contacts professional and advocacy groups interested in the committee's work.
9. Performs administrative tasks such as corresponding with committee members, participating in the planning and execution of committee meetings, and other tasks associated with preparing for committee meetings and workshops.
10. Serves as a mentor and/or resource to employees. May be responsible for training and supervising junior staff.
11. May assist senior staff in researching and identifying potential speakers and committee and forum members.
NONESSENTIAL JOB DUTIES
Related duties and special projects as assigned.
Required Knowledge, Skills, and Abilities: Ability to solve intellectual problems of appreciable variety and complexity using originality and ingenuity. Ability to exercise appreciable latitude for independent judgment and action. Experience working in complex environments with a high degree of organizational effectiveness. Ability to work successfully in a team environment. Ability to develop relationships with co-workers and employees in other National Academies' departments through effective communication. Excellent communication skills with a proven ability to effectively interact with all levels of employees.
An interest in FDA regulatory policy, drug safety and efficacy, and/or drug compounding a plus.
Minimum Education/Training Requirements: Bachelor's degree in a related field or equivalent knowledge.
Minimum Experience: Two years of related professional experience.
Preferred Education and Experience: Master's degree in a related field.
Physical Capabilities: Ability to work at a computer for extended periods of time. Ability to travel.
Required Licenses, Certification or Registration: None.
Supervisory Responsibilities/Controls: Reports to program officer/director. Sets objectives with supervisor.
Work Environment: Office environment, with occasional travel between National Academies' facilities and to off-site meeting/sponsor locations.
Any qualification to be considered equivalent, in lieu of stated minimum, requires the prior approval of the Office of Human Resources.
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. Some functions in this description may be specific to a particular unit of the National Academies and not applicable to other units.