Epidemiologist Writer
About The Position
DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, state and local government and commercial clients in health care, technology, and financial services industries. The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing challenges - together. We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward-thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make vision a reality. CBER expects to receive biologics licensure applications (BLAs) for vaccines, and high-profile and complex BLAs and BLA efficacy supplements for non-COVID-19 vaccines and other products. Some submissions will require expedited review and preparation of review memoranda and briefing documents for advisory committee meetings that will inform regulatory decisions for these products. Preparation of these documents, including ensuring appropriate and consistent formatting, quality checking for accuracy of data summaries, and compliance with Section 508 requirements for reader accessibility, has historically been the responsibility of medical officers (MOs), regulatory project managers (RPMs) and their supervisors, who are also responsible for primary review of data and analyses contained in the submissions. In order to ensure that review efforts are not adversely impacted during this time of high workload and compressed review timelines, CBER requires assistance with preparation of review memoranda, briefing documents, and other associated work products.
Requirements
- A minimum of 3 years’ experience in pharmacoepidemiologic studies using large health claims databases or electronic health records systems.
- Excellent writing skills and experience with document preparation, together with strong formatting, editing, and organization skills.
- Experience in synthesizing and disseminating information regarding complex issues, decisions, or policies.
- project management skills to plan, organize and coordinate numerous projects and time sensitive assignments.
- Capable computer skills to execute the tasks required by the position; knowledgeable about scientific and document preparation software: Word, Excel, PowerPoint, or similar reference software.
Nice To Haves
- Familiarity with FDA regulation of drugs and biological products and EUA and BLA review processes.
- Familiarity with Section 508 requirements for reader accessibility.
Responsibilities
- Assist CBER/OBPV staff in preparing first drafts/multiple drafts of responses to requests for information on biologics from a variety of sources including the public, academia, the media, and government sources. The writers will edit responses prepared by CBER staff to ensure they are concise, clear, and suitable for the intended audience.
- Support the development of scientific manuscripts including study protocols, white papers, presentations, and manuscripts for submission to peer-reviewed journals. Examples include protocols at https://www.bestinitiative.org/vaccines-and-allergenics and a recently published article at https://doi.org/10.1093/cid/ciab125.
- Assist in the development of visual communication aids including graphs, figures, and infographics.
- Assist CBER/OBPV staff in reviewing and interpreting data analyses and suggest additional analysis.
Benefits
- Salary commensurate with experience.
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What This Job Offers
Job Type
Part-time
Career Level
Mid Level
