Clinical Pharmacologist Writer

DRT Strategies, Inc.•Silver Spring, MD

2d•$80,000 - $105,000•Remote

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. Project Description: 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. Job Summary: The Clinical Pharmacologist Writer will develop knowledge of CBER/OBPV review processes, concepts central to the review of vaccines and related biological products, and established OBPV and CBER-wide practices and templates used for preparation of review memoranda, advisory committee briefing documents, and other associated work product needed to document FDA review of and regulatory action for vaccines and related biological products. The Clinical Pharmacologist Writer will meet regularly with CBER/OBPV senior leadership and review branch managers to prioritize assignments and coordinate expectations for completion of assignments. CBER/OBPV leadership and branch managers will provide advance notice, as able, of anticipated regulatory submissions for which the Contractor’s assistance will be needed. The Contractor shall maintain flexible work hours to accommodate needs that may change during compressed review timelines. The Clinical Pharmacologist Writer will ensure that all work complies with laws, polices and regulations applicable to CBER’s practices for review of vaccines and related biological products.

Requirements

A minimum of least 3 years’ experience in pharmacoepidemiology 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.