Scientific Writer

Overview

DRT Strategies delivers expert management consulting and information technology (IT) solutions to federal agencies, state and local governments, and commercial clients in health care, technology, and the 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 IT 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.

DRT Strategies, Inc. (DRT) celebrates diversity and is proud to provide Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetics, disability, or protected veteran status. In addition to federal law requirements, DRT complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.

Project Summary  

Presently, due to the COVID-19 pandemic, DRT employees are teleworking from home, however a requirement of this position will be to report to the worksite.

Please note that, as a government contractor, DRT may be required to ask for proof of your COVID-19 vaccination status upon hire or anytime thereafter.

Position Summary

The Medical Writer/Editor will support scientists at the US Food and Drug Administration (FDA) who regulate gene therapy, cell therapy, tissue transplantation and other biological treatments for human diseases. The Medical Writer/Editor will work closely with FDA scientists to write and edit regulatory documents, manuscripts for submission to medical journals, and materials for presentation at scientific conferences. The position requires demonstrated skill in medical writing/editing and the ability to understand and interpret data from clinical trials. Preferred candidates will have an advanced degree in a scientific or health-related field and/or work experience as a medical writer/editor.

Responsibilities

• Work with teams of FDA scientists to write and edit regulatory documents such as product reviews and policy guidelines
• Review and summarize literature to draft background sections for product reviews; summarize clinical trial designs using details from clinical study reports
• Edit product review documents to correct tone, flow, verb tense, and style; make decisions regarding style and consistency of terms; identify factual errors and misstatements; suggest revisions for clarity and brevity
• Draft original manuscripts from outlines provided by FDA scientists; incorporate comments from multiple authors into successive drafts; assist authors with submission to journals and addressing comments from peer review
• Edit manuscripts written by FDA scientists, critically reviewing for completeness, balance, and fitness of conclusions
• Format data tables; create and populate data tables using data derived from regulatory submissions to the FDA
• Insert and manage citations and references; perform routine formatting tasks such applying Microsoft Word styles and field-coded captions to ensure the functionality of automated tables of contents and lists of tables and figures
• Using records of communication between the FDA and sponsors of biological products such as gene therapies, develop and maintain a database of answers to questions most frequently asked by sponsors, organizing them by topic area (e.g., trial design, blinding, randomization)
• Communicate efficiently and effectively with FDA scientists regarding requirements and timelines for writing/editing projects
• Perform routine quality checks on work performed by other medical editors
• Provide support for the onboarding and training of new medical editors as needed

Required Experience  

• Degree in a scientific or health field
• Able to understand and follow scientific discussion on clinical trials, adverse events, treatment efficacy, and product labeling
• At least 2 years of experience as a medical writer/editor
• Adept with English grammar, spelling, punctuation
• Familiar with Microsoft Word including track changes
• Attention to detail (e.g., ability to recognize an extra space between words or in the cell of a data table)
• Willing to perform mundane formatting tasks

Preferred Experience

• Advanced degree such as MPH, PharmD, or PhD
• Academic or professional experience with biologics such as vaccines, blood products, gene therapy, stem cells, or tissue transplantation
• Author of medical journal publications
• Familiar with FDA regulatory processes
• Familiar with AMA style
• Familiar with Section 508 compliance
• Savvy with Microsoft Word features such as styles, captioning, and cross-referencing
• Experience with SharePoint, EndNote, Adobe Acrobat, Excel, PowerPoint

DRT Strategies, Inc. (DRT) celebrates diversity and is proud to provide Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetics, disability, or protected veteran status. In addition to federal law requirements, DRT complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.

Presently, due to the COVID-19 pandemic, DRT employees are teleworking from home and leveraging video conferencing along with other virtual productivity tools. During normal circumstances, the requirement of this position is to be onsite, however, DRT has not yet determined when employees will be required to return to their workspaces. Please be aware that at the time a date is determined, the requirement of this position will be to report to the worksite.

At this time, Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors, which mandated the creation of a Federal Acquisition Regulation clause requiring federal contractors and subcontractors to be fully vaccinated from COVID-19, is in a pending status. Please note that, as a government contractor, DRT may be required to ask for proof of your COVID-19 vaccination status upon hire or anytime thereafter if the executive order is upheld. Per the requirement, federal contractors and subcontractors must submit proof of vaccination against COVID-19 or have an approved accommodation to begin work.