Clinical Pharmacologist Writer - Flexible Hours FDA-Ready

DRT Strategies; Silver Spring (MD); On-site; USD 80,000 - 105,000; Full time

Job summary

DRT Strategies, Inc. is seeking a Clinical Pharmacologist Writer to support FDA CBER/OBPV review processes, focusing on vaccines and related biologics. You will draft review memoranda, briefing documents, and ensure accessibility and compliance with internal templates.

You will prioritize assignments with senior leadership, coordinate timelines for regulatory submissions, and maintain rigorous quality standards across all deliverables.

Qualifications

• Minimum of 3 years’ experience in pharmacoepidemiology studies using large health claims databases or electronic health records.
• Excellent writing, formatting, editing, and document preparation with strong organization skills.
• Experience synthesizing and disseminating information regarding complex issues, decisions, or policies.
• Project management to plan, organize and coordinate numerous projects and time-sensitive assignments.

Responsibilities

• Assist CBER/OBPV staff in preparing first drafts/multiple drafts of responses to requests for information on biologics from a variety of sources including the public, academia, the media, and government sources. The writers will edit responses prepared by CBER staff to ensure they are concise, clear, and suitable for the intended audience.
• Support the development of scientific manuscripts including study protocols, white papers, presentations, and manuscripts for submission to peer-reviewed journals. Examples include protocols at https://www.bestinitiative.org/vaccines-and-allergenics and a recently published article at https://doi.org/10.1093/cid/ciab125.
• Assist in the development of visual communication aids including graphs, figures, and infographics.
• Assist CBER/OBPV staff in reviewing and interpreting data analyses and suggest additional analysis.

Skills

Pharmacoepidemiology

Writing

Data synthesis

Project management

MS Office

Education

Post Doctorate Degree in Pharmacology

Tools

Word

Excel

PowerPoint

Job description

DRT Strategies, Inc. is seeking a Clinical Pharmacologist Writer to support FDA CBER/OBPV review processes, focusing on vaccines and related biologics. You will draft review memoranda, briefing documents, and ensure accessibility and compliance with internal templates.

You will prioritize assignments with senior leadership, coordinate timelines for regulatory submissions, and maintain rigorous quality standards across all deliverables.