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:
The Medical Editor-Writer will support scientists at the U.S. Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER), particularly the Office of New Drugs (OND). The project supports FDA scientists who review applications submitted to the Agency to ensure that safe and effective drugs and biologics are available for the American people.
Job Summary:
The Medical Editor will draft, format, and/or edit regulatory documents in collaboration with FDA scientists. The position requires the ability to utilize a style guide to apply language and formatting standards, working proficiency with Microsoft Office and SharePoint, a willingness to stay current with regulatory standards and guidelines, and the ability to excel in a customer-focused environment. Preferred candidates will have education or experience in a scientific or healthcare field.
Responsibilities:
Work with a team of editors and writers to manage document control, edit and format for consistency and one voice; work with FDA stakeholders in their review of complex scientific documents including reviews of new drug applications, policy documents, committee briefings, and slide presentations.
Drafting and/or editing SOPs, SOPPs, manuscripts, and/or other policy documents.
Familiarity with a style guide and applying formatting and language standards consistently, making decisions regarding elements of style not mentioned in the style guide, and applying such decisions uniformly throughout a document.
Identifying errors in grammar, spelling, punctuation; correct tone, flow, verb tense, and style.
Recognizing and correcting inconsistent use of scientific terms used in text or data tables.
Using Microsoft Word styles and field-coded captions to ensure the functionality of automated tables of contents and lists of tables and figures.
Inserting and managing citations and references; creating lists of abbreviations and ensuring correct use of acronyms and abbreviations within documents.
Formatting data tables; creating and populating data tables using data derived from regulatory submissions to the FDA.
Creating and maintaining consistently formatted document templates.
Communicating efficiently and effectively with FDA scientists regarding requirements and timelines for editing projects.
Performing routine quality checks on work performed by other copy editors.
Providing support for the onboarding and training of new copy editors as needed.
Creating and maintaining internal documents such as style guides, process documents, and training materials.
Required Experience:
Adept with English grammar, spelling, and punctuation.
Ability to read and understand a data table.
Attention to detail (e.g., ability to recognize text of a different font/style within a paragraph and identify document-wide inconsistencies).
Working proficiency with Microsoft Office Suite and SharePoint, including familiarity with Microsoft Word (e.g., track changes).
Ability to read, generate, and edit scientific content, such as journal articles or regulatory documents
Ability to fact-check scientific writing and data.
Preferred Experience:
Work experience as a scientific writer.
Experience with the FDA and/or pharmaceutical industry.
Savvy with Microsoft Word features such as styles, captioning, and cross-referencing.
Experience in a regulatory, healthcare, laboratory, or pharmaceutical industry.
Familiarity with a style guide (e.g., AP, AMA).
Familiarity with Section 508 compliance.
Experience with Visual Basic, EndNote, Adobe Acrobat.
Education & Training:
Advanced degree required (Master's, PhD, MD, etc.); degree in a Scientific or Health Field preferred. Prior FDA or regulatory experience is preferred.
5+ years of related experience required with a Master's.
1+ years of related experience required with a PhD, MD, etc.
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.
This position is on-site in White Oak, MD.
Salary Range:
$80,000-$110,000
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.
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 hr@drtstrategies.com if you believe you have received a fraudulent email.
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