Medical Editor - CDER

drtstrategies; Silver Spring (MD); On-site; USD 60,000 - 75,000; Full time

Job summary

DRT Strategies is seeking a Medical Editor to edit and format reviews of marketing applications and policy documents for the FDA CDER, Office of New Drugs. You will attend and summarize meetings with FDA stakeholders, maintain consistency across documents, and manage deadlines with a team of editors.

The role requires excellent organizational and communication skills, proficiency with MS Word and MS Office, and the ability to work in a fast-paced environment with tight timelines and multiple

Qualifications

• Bachelor’s degree in a STEM field is preferred.
• Strong organizational, written and verbal communication skills.
• Experience editing scientific or policy documents is a plus.

Responsibilities

• Edit and format reviews of marketing applications and policy documents for consistency and a single voice.
• Perform copy editing for grammar, punctuation, style, and internal consistency.
• Conduct literature searches to support editing and revision of document content.
• Manage SharePoint organization and updates; ensure Section 508 compliance.
• Interact with FDA stakeholders to establish project requirements, scope, risks, and deliverables.

Education

Bachelor’s degree (STEM disciplines preferred)

Tools

MS Office

Microsoft Word

Job description

Overview

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, andfinancial 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

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

Required Experience

• 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

Preferred Experience

• 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

Education & Training

• Bachelor’s degree (STEM disciplines preferred)

Work Authorization, Clearance Requirement, & Additional Information

• 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.

Salary Range

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

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 [e-mail], or by dialing 571-482-2517.

For additional information, please review the Know Your Rights: Workplace Discrimination is Illegal, E-Verify (English), E-Verify (Spanish). Right to Work (English), Right to Work (Spanish).

Please be aware of recruitment fraud where malicious individuals might pose as DRT Strategies. Only job postings and emails from drtstrategies.com are authentic and legitimate communications regarding DRT Strategies employment opportunities. Please contact Human Resources at [e-mail] if you believe you have received a fraudulent email.