Medical Editor

DRT Strategies, Inc; Silver Spring, Northern (MD, KY); On-site; USD 70,000 - 90,000; Full time

Job summary

DRT Strategies, Inc. seeks a Medical Editor to edit and format reviews of marketing applications and policy documents, and to attend FDA stakeholder meetings as needed.

The editor will work with FDA leadership and other offices to ensure accuracy, consistency, and one-voice documentation. The role requires organization, attention to detail, reliability, and the ability to interact with FDA stakeholders across several Offices and Divisions.

Qualifications

• Must obtain and maintain a U.S. government Public Trust clearance.
• Citizenship or lawful permanent residence required.
• No agencies, third parties, or Corp-to-Corp submissions.
• Experience editing medical/marketing applications and FDA policy documents preferred.
• Strong editing and formatting skills with attention to detail.
• Ability to coordinate with FDA stakeholders across offices and divisions.

Responsibilities

• Edit and format reviews of marketing applications and policy documents for consistency.
• Attend and summarize meetings with FDA stakeholders as needed.
• Draft and summarize materials with senior leadership guidance.
• Manage document control with a team of medical editors for one voice.
• Perform literature searches to support editing revisions.
• Conduct routine quality checks on editors' work.
• Organize and update SharePoint sites for project needs.

Skills

Process-oriented

Fast-paced work

Relationship building

Meeting minutes

Organization & time management

Project management

SharePoint

MS Office proficiency

MS Word advanced

Education

Bachelor's Degree

Master's in STEM

Tools

SharePoint

EndNote

Visual Basic

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 scientific writing and medical editing support to the FDA Center for Biologics Evaluation and Research (CBER). The project supports the FDA’s mission to ensure that safe and effective 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 medical editor will work closely with CBER leadership, attend internal and external meetings, draft and summarise 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 medical editors 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 emergency use authorizations, marketing applications, policy documents, committee briefings, and slide presentations.
• 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.
• Assist with overall project support as needed.

Required Experience

• Process-oriented and results driven.
• Ability to deliver in a fast-paced environment under tight deadlines.
• Highly adept in building relationships.
• Ability to take meeting minutes and synthesize discussion points.
• Excellent organizational, time management, and communication skills.
• Ability to independently manage a variety of projects with frequent interruptions and shifting priorities to complete work in a timely manner and meet mandatory deadlines.
• Ability to work in SharePoint online or SharePoint 2010 concurrently with multiple users.
• Experience with MS Excel, Word, PowerPoint, and Visio.
• Intermediate experience and/or certification in Microsoft Word with willingness to learn new features.

Preferred Experience

• Master's in STEM background.
• 5+ years of medical editing experience and familiarity with a style guide (e.g., AP, Chicago, or AMA).
• Experience editing guidelines or other policy documents for the federal government.
• Familiarity with SharePoint, EndNote, and Visual Basic.
• Familiarity with 508 compliance.
• Experience preparing drug applications in the pharmaceutical industry.
• Ability to understand and follow scientific discussion on drugs, side effects, placebo effects, adverse events, and labeling.
• Familiarity with FDA regulatory process and/or past work experience with FDA.

Education & Training

• Bachelor's Degree

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

• $70,000-$90,000
• 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).