FDA-Regulatory Scientific Writer & Editor

DRT Strategies, Inc; Silver Spring, Northern (MD, KY); Hybrid; USD 100,000 - 130,000; Full time

Job summary

DRT Strategies, Inc. delivers scientific writing and editing support for FDA CBER, with a focus on memo drafting, regulatory history, and manuscript preparation.

The role requires meticulous editing, stakeholder communication, and adherence to FDA review processes. The consultant will produce high-quality documents, manage version control, and coordinate with editors to ensure a single voice across materials.

Qualifications

• 5+ years of scientific writing and copy-editing experience.
• Experience synthesizing and disseminating scientific information regarding complex issues, decisions, or policies.
• Familiarity with a style guide (e.g., AP, Chicago, or AMA).
• Excellent organizational, time management, and communication skills, demonstrated experience working independently as well as in a team environment.
• Ability to take scientific meeting minutes and synthesize discussion points for stakeholders
• Computer skills: MS Office and reference software.
• Intermediate experience and/or certification in Microsoft Word with willingness to learn new features.

Responsibilities

• Work with FDA stakeholders in their review of complex scientific documents including post-market memoranda, manuscripts, policy documents, committee briefings, and slide presentations.
• Draft scientific content including study protocols, white papers, presentations, and manuscripts for submission to peer-reviewed journals.
• 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.
• Draft, Perform routine quality checks on the work of other medical writers/editors.
• Assist in the development of visual communication aids including graphs, figures, and infographics.
• Work with a team of editors and writers to manage document control, edit and format for consistency and one voice.
• Help customers to identify ineffective or inefficient process areas and to make improvement recommendations.
• Assist DRT to identify other areas where our Health Science practitioners can help current and future customers
• Check document for 508 Compliance.
• Work with FDA stakeholders on requirement gathering, project scope, risks and deliverables.
• Assist with overall project support as needed.

Skills

Scientific writing

Copy-editing

MS Office

Communication

Time management

Meeting minutes

Team collaboration

Education

Master’s or PhD in biomedical sciences

Tools

SharePoint

EndNote

Visual Basic

Microsoft Word

Job description

DRT Strategies, Inc. delivers scientific writing and editing support for FDA CBER, with a focus on memo drafting, regulatory history, and manuscript preparation.

The role requires meticulous editing, stakeholder communication, and adherence to FDA review processes. The consultant will produce high-quality documents, manage version control, and coordinate with editors to ensure a single voice across materials.