Clinical Pharmacologist Writer for FDA Submissions (Flexible Hours)

DRT Strategies, Inc

Silver Spring (MD)

On-site

USD 80,000 - 105,000

Full time

14 days+

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Job summary

DRT Strategies, Inc seeks a Clinical Pharmacologist Writer to support regulatory review processes for vaccines and biologics. You will work with OBPV/CBER teams to prepare review memoranda, briefing documents, and other work products for regulatory action.

You will meet with leadership to prioritize assignments and ensure timely delivery. U.S. citizenship or clearance eligibility is required to work on federal contracts, with compensation aligned to market rates.

Qualifications

Minimum of 3 years’ experience in pharmacoepidemiology using large health claims databases or electronic health records systems.
Excellent writing, editing and document preparation skills.
Experience 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 with 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 various sources.
Support the development of scientific manuscripts including protocols, white papers and presentations.
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 analyses.