Medical Editor, Jr.
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:
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.
Job 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
- 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
- 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
- Bachelor’s degree (STEM disciplines preferred)
- $46,000-62,000
- Salary commensurate with experience.
DRT offers full-time benefit eligible employees a competitive total compensation package. Employees may begin participating in employer sponsored group medical, dental, and vision coverage on their first day of employment. DRT also has a 401(K)-retirement plan, company paid short-term and long-term disability, life insurance, AD&D coverage, and an employee assistant program (EAP). Employees may also elect critical illness coverage, accident coverage, flexible spending accounts, and health saving account options. The DRT leave programs include Paid Time Off (PTO) each calendar year, paid holidays annually, paid parental leave, and unpaid job protected leave administered in accordance with the Family Medical Leave Act (FMLA).
DRT Strategies, Inc. (DRT) follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related conditions, transgender status, and sexual orientation), national origin, age, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.
Reasonable accommodations for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing HR@drtstrategies.com, or by dialing 571-482-2517.
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