Medical Editor - CDER at DRT Strategies in Silver Spring, MD

Job description

• 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.
• 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.
• 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

Requirements

• Ability to take meeting notes and synthesize into major discussion points
• 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
• Intermediate experience and/or certification in Microsoft Word with willingness to learn advanced features
• Bachelor’s degree (STEM disciplines preferred)
• This position requires the ability to obtain and maintain a U.S. government Public Trust clearance. Due to contract requirements, candidates must be U.S. citizens or lawful permanent residents (green card holders) to be eligible.
• No agencies, third parties, or Corp-to-Corp submissions.
• Experience editing guidelines or other policy documents for the federal government
• 2+ years of copy-editing experience and familiarity with a style guide (e.g., AP, Chicago, or AMA)
• 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

Skills

Required

• MS Office
• Copy editing
• Meeting notes synthesis
• Organizational skills
• Time management
• Communication skills
• Project management
• Attention to detail
• Ability to manage tight deadlines

Preferred

• SharePoint
• EndNote
• Visual Basic
• Section 508 compliance
• Style guides (AP, Chicago, or AMA)
• FDA regulatory process
• Pharmaceutical industry experience

Benefits

• $60,000-$75,000
• Salary commensurate with experience.