Epidemiologist Writer
Job Location:
Silver Spring, MD - USA
Hourly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 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 Epidemiologist 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 Epidemiologist 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 Contractors assistance will be needed. The Contractor shall maintain flexible work hours to accommodate needs that may change during compressed review timelines. The Epidemiologist Writer will ensure that all work complies with laws polices and regulations applicable to CBERs 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 and a recently published article at
- 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.
- A 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.
- Familiarity with FDA regulation of drugs and biological products and EUA and BLA review processes.
- Familiarity with Section 508 requirements for reader accessibility.
- Post Doctorate Degree in Epidemiology Public Health or related Health Science Field
- 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.
- $40-50/hour
- 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 or by dialing .
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 are authentic and legitimate communications regarding DRT Strategies employment opportunities. Please contact Human Resources at if you believe you have received a fraudulent email.
Required Experience:
Senior IC
About Company
Management Consulting, Technology, and Project Management | Certified Woman-Owned Business
