Medical Editor

Company: DRT Strategies, Inc.
Location: Silver Spring
Posted on: August 6, 2022

Job Description:

Job Description 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 Drug Evaluation and Research (CDER), particularly the Office of New Drugs (OND). 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 Medical Editor will edit and format reviews of marketing applications and policy documents as well as attend and summarize meetings with FDA stakeholders as needed. The position requires excellent organizational and communication skills, attention to detail, consistency, ability to manage tight deadlines, and frequent 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 reviews of new drug applications, policy documents, committee briefings, and slide presentations Perform copy editing for grammar, punctuation, style, and internal consistency Perform literature searches to assist with editing and revision of document content Perform routine quality checks on work done by fellow medical writers/editors Manage SharePoint site organization and updates Check document for Section 508 compliance Work with FDA stakeholders on establishing project requirements, scope, risks, and deliverables Oversee task order project management including financials and forecast Participate in management activities as defined by management team Assist with overall project support as needed Required Experience Bachelor---s degree 2 years of copy-editing experience and familiarity with a style guide (e.g., AP, Chicago, or AMA) Excellent organizational, time management, and communication skills Ability to independently manage a diverse portfolio of projects to complete work in a timely manner and meet mandatory deadlines despite frequent interruptions and shifting priorities Computer skills: MS Office Entry level experience and/or certification in Microsoft Word with willingness to learn advanced features Preferred Experience Bachelor---s degree in STEM disciplines preferred Experience editing guidelines or other policy documents for the federal government Familiarity with SharePoint, EndNote, and Visual Basic Familiarity with Section 508 compliance Experience preparing drug applications in the pharmaceutical industry Ability to understand and follow scientific discussion on drugs, clinical trials, adverse events, treatment effects, and product labeling Familiarity with FDA regulatory process Education and Training Bachelor---s degree 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. 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. At this time, Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors , which mandated the creation of a Federal Acquisition Regulation clause requiring federal contractors and subcontractors to be fully vaccinated from COVID-19, is in a pending status. Please note that, as a government contractor, DRT may be required to ask for proof of your COVID-19 vaccination status upon hire or anytime thereafter if the executive order is upheld. Per the requirement, federal contractors and subcontractors must submit proof of vaccination against COVID-19 or have an approved accommodation to begin work. Powered by JazzHR MAqAgox9dy

Keywords: DRT Strategies, Inc., Silver Spring , Medical Editor, Healthcare , Silver Spring, Maryland