Clinical Pharmacologist Writer

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

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.

Skills

Pharmacoepidemiology

Writing skills

Project management

Data interpretation

Microsoft Word

Excel

PowerPoint

Education

Post Doctorate Degree in Pharmacology

Tools

Word

Excel

PowerPoint

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

CBER expects to receive biologics licensure applications (BLAs) for vaccines, and high-profile and complex BLAs and BLA efficacy supplements for non-COVID-19 vaccines and other products. Some submissions will require expedited review and preparation of review memoranda and briefing documents for advisory committee meetings that will inform regulatory decisions for these products. Preparation of these documents, including ensuring appropriate and consistent formatting, quality checking for accuracy of data summaries, and compliance with Section 508 requirements for reader accessibility, has historically been the responsibility of medical officers (MOs), regulatory project managers (RPMs) and their supervisors, who are also responsible for primary review of data and analyses contained in the submissions. In order to ensure that review efforts are not adversely impacted during this time of high workload and compressed review timelines, CBER requires assistance with preparation of review memoranda, briefing documents, and other associated work products.

Job Summary

The Clinical Pharmacologist Writer will develop knowledge of CBER/OBPV review processes, concepts central to the review of vaccines and related biological products, and established OBPV and CBER-wide practices and templates used for preparation of review memoranda, advisory committee briefing documents, and other associated work product needed to document FDA review of and regulatory action for vaccines and related biological products. The Clinical Pharmacologist Writer will meet regularly with CBER/OBPV senior leadership and review branch managers to prioritize assignments and coordinate expectations for completion of assignments. CBER/OBPV leadership and branch managers will provide advance notice, as able, of anticipated regulatory submissions for which the Contractor’s assistance will be needed. The Contractor shall maintain flexible work hours to accommodate needs that may change during compressed review timelines. The Clinical Pharmacologist Writer will ensure that all work complies with laws, polices and regulations applicable to CBER’s practices for review of vaccines and related biological products.

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.

Required Experience

• A minimum of least 3 years’ experience in pharmacoepidemiology 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.

Preferred Experience

• Familiarity with FDA regulation of drugs and biological products and EUA and BLA review processes.
• Familiarity with Section 508 requirements for reader accessibility.

Education & Training

• Post Doctorate Degree in Pharmacology

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

• $80,000-105,000
• 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).

Please be aware of recruitment fraud where malicious individuals might pose as DRT Strategies. Only job postings and emails from drtstrategies.com are authentic and legitimate communications regarding DRT Strategies employment opportunities. Please contact Human Resources at [e-mail] if you believe you have received a fraudulent email.