Part-Time Epidemiologist Writer — Regulatory Briefs

DRT Strategies, Inc; Silver Spring (MD); On-site; USD 55,000 - 69,000; Part time

Job summary

DRT Strategies, Inc. seeks an Epidemiologist Writer on a part-time basis to develop and prepare regulatory review materials for biologics submissions.

The role involves drafting responses, coordinating with OBPV/CBER leadership, and ensuring accessibility and compliance with standard templates and quality controls. The ideal candidate will have at least 3 years in pharmacoepidemiology using large health data, strong writing and editing skills, and ability to manage multiple complex projects with

Qualifications

• Minimum of 3 years’ experience in pharmacoepidemiologic studies using large health claims databases or electronic health records systems.
• Excellent writing skills and experience with document preparation, together with strong formatting, editing, and organization skills.
• Experience in synthesizing and disseminating information regarding complex issues, decisions, or policies.
• Project management skills to plan, organize and coordinate numerous projects and time sensitive assignments.
• Capable computer skills to execute the tasks required by the position; knowledgeable about scientific and document preparation software: Word, Excel, PowerPoint, or similar reference software.

Responsibilities

• Assist CBER/OBPV staff in preparing first drafts/multiple drafts of responses to requests for information on biologics from diverse sources; edit responses to be concise and clear.
• Support development of scientific manuscripts including protocols, white papers, presentations, and manuscripts for submission to peer-reviewed journals.
• Assist in development of visual communication aids including graphs, figures, and infographics.
• Assist CBER/OBPV staff in reviewing and interpreting data analyses and suggesting additional analyses.

Skills

Excellent writing skills

Document preparation

Editing

Project management

Microsoft Word

Microsoft Excel

PowerPoint

Education

Post Doctorate Degree in Epidemiology, Public Health, or related Health Science Field

Tools

Word

Excel

PowerPoint

Job description

DRT Strategies, Inc. seeks an Epidemiologist Writer on a part-time basis to develop and prepare regulatory review materials for biologics submissions.

The role involves drafting responses, coordinating with OBPV/CBER leadership, and ensuring accessibility and compliance with standard templates and quality controls. The ideal candidate will have at least 3 years in pharmacoepidemiology using large health data, strong writing and editing skills, and ability to manage multiple complex projects with