Scientific Writer (PhD/Masters Degree Required - Epidemiology or Statistics)
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Overview DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, the U.S. Navy, state and local government and commercial clients in health care, technology, and the financial services industries. The three letters of our name, DRT, stand for Driving Resolutions Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing IT 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 your vision a reality. Project Summary The project provides on-site information technology project management and medical writing and editing support to the FDA Center for Biologics and Research (CBER), particularly the Office of Biostatistics and Epidemiology (OBE). The project supports the FDA’s mission to ensure that safe and effective drugs and biologics are available to the American people. Position Summary The Scientific Writer will support FDA OBE staff prepare post-market memoranda, edit and format reviews memos and policy documents as well as attend and summarize meetings with FDA stakeholders as needed. The position requires organization, attention to detail, reliability, consistency, and interaction with FDA stakeholders across several Offices and Divisions. Responsibilities
Work with a team of editors and writers to manage document control, edit and format for consistency and one voice; work with FDA stakeholders in their review of complex scientific documents including post-market memoranda, policy documents, committee briefings, and slide presentations
Develop scientific manuscripts including study protocols, white papers, presentations, and manuscripts for submission to peer-reviewed journals
Assist in the development of visual communication aids including graphs, figures, and infographics
Perform copy editing for grammar, punctuation, style, and internal consistency
Analyze and evaluate the requirements for assigned writing and editing tasks
Perform literature searches as needed to assist with editing and revision of document content
Perform routine quality checks on the work of other medical writers/editors
Manage SharePoint site organization and updates
Work collaboratively with other colleagues to share lessons learned and to assist when needed
Help customers to identify ineffective or inefficient process areas and to make improvement recommendations
Assist DRT to identify other areas where our Health Science practitioners can help current and future customers
Check document for 508 Compliance
Work with FDA stakeholders on requirement gathering, project scope, risks and deliverables.
Assist with overall project support as needed
Optional - Work closely with FDA stakeholders to verify and analyze data to identify trends and relationships.
Required Experience
Master’s or PhD degree in epidemiology or statistics. Candidates with experience in infectious disease and public health can also apply
At least 3 years’ experience in pharmacoepidemiology studies using large health claims databases or electronic health records systems
2+ years of copy-editing experience and familiarity with a style guide (e.g., AP, Chicago, or AMA)
Ability to take meeting minutes and synthesize discussion points
Excellent organizational, time management, and communication skills
Demonstrated experience working independently as well as in a team environment
Experience in synthesizing and disseminating information regarding complex issues, decisions, or policies
Computer skills: MS Office and reference software
Intermediate experience and/or certification in Microsoft Word with willingness to learn new features
Preferred Experience
Experience editing guidelines or other policy documents for the federal government
Familiarity with SharePoint, EndNote, and Visual Basic
Familiarity with 508 compliance
Familiarity with FDA regulation of drugs and biological products and EUA and BLA review processes
Ability to understand and follow scientific discussion on drugs, side effects, placebo effects, adverse events, and labeling
Presently, due to the COVID-19 pandemic, DRT employees are teleworking from home and leveraging video conferencing along with other virtual productivity tools. During normal circumstances, the requirement of this position is to be onsite, however, DRT has not yet determined when employees will be required to return to their workspaces. Please be aware that at the time a date is determined, the requirement of this position will be to report to the worksite. DRT Strategies, Inc. (DRT) celebrates diversity and is proud to provide Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetics, disability, or protected veteran status. In addition to federal law requirements, DRT complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.
