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, and financi…
Skills: Pharmacoepidemiology, Technical writing, Regulatory documentation, Data analysis, Project management
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, and financi…
Skills: Epidemiology, Pharmacoepidemiology, Technical writing, Regulatory documentation, Data analysis
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MS, PhD, Research Scientist, Machine Learning, Atmospheric Science
Silver Spring, Maryland, United States · Remote OK
$90k–$110k/yr
Mid level
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Phlebotomist Representative I - Hospital - Silver Spring, MD, Monday to Friday, Day may vary 9:00 PM to 5:30 AM, with rotational weekends Represents the face of our company to patients within the hospital systems at Ques…
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Silver Spring, Maryland, United States · On-site
$20/hr–$27/hr
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$80k–$105k/yr
Full-time
postgraduate degree
Posted 14d ago
Apply by Nov 26
~40 hrs/week
Responsibilities
The Clinical Pharmacologist Writer will prepare review memoranda, advisory committee briefing documents, and other regulatory work products for biologics licensure applications. They will also assist staff in interpreting data analyses and developing scientific manuscripts, presentations, and visual communication aids.
Requirements
Candidates must hold a Post Doctorate degree in Pharmacology and possess at least 3 years of experience in pharmacoepidemiology using large health databases. Strong writing, editing, and project management skills are required, along with the ability to obtain a U.S. government Public Trust clearance.
Full 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, and financial 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.
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 HR@drtstrategies.com, or by dialing 571-482-2517.
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 hr@drtstrategies.com if you believe you have received a fraudulent email.
Related keywords
PharmacoepidemiologyClinical PharmacologyFDACBEROBPVBiologicsVaccinesBLARegulatory AffairsTechnical WritingData AnalysisPublic Trust ClearanceSection 508Scientific ManuscriptsHealth Claims DatabasesElectronic Health Records
DRT Strategies, Inc. (DRT) is an award-winning technology innovator and leading digital transformation partner to large federal agencies and commercial clients for nearly 20 years. The company is a ServiceNow™ Partner - Specialist, Amazon Web Services (AWS) Consulting Partner, UiPath Partner, SAFe Bronze Partner, Esri Bronze Partner, and holds ISO 9001:2015, ISO/IEC 20000-1:2018, and ISO/IEC 27001:2013 certifications and has achieved CMMI-DEV Level 3.
DRT is headquartered in Arlington, Virginia, with offices in Atlanta, Georgia. More information on the company can be found at www.drtstrategies.com.
Offices: 1001 19th St N, Suite 1200, Arlington, Virginia 22209, US · 5502 Peachtree Rd, Suite 225, Chamblee, Georgia 30341, US
Agile IT ManagementHealth Information ManagementPortfolioProgram & Project ManagementFinancial TransformationStrategy & ChangeTechnology TransformationCybersecurityIT Service Management & ITILServiceNow
How many Science & Research jobs are open in Silver Spring, MD right now?
There are currently 121 open science & research positions in Silver Spring, MD listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Silver Spring, MD?
Companies currently hiring include St. Peter's Health Partners, Adventist HealthCare, FWI (FedWriters, Inc.), Quest Diagnostics, United Therapeutics Corporation, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Silver Spring, MD?
Yes — 42 of the 121 open science & research positions offer remote or hybrid work (17 remote, 25 hybrid).
How do I apply for Science & Research jobs in Silver Spring, MD?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.