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Healthcare Editorial Specialist

2 months ago

Silver Spring, Maryland, United States DRT Strategies, Inc. Full time
Job Overview

DRT Strategies, Inc. is a leader in management consulting and information technology solutions, providing exceptional services to federal agencies, including the U.S. Navy, as well as state and local governments and commercial clients in the healthcare, technology, and financial sectors.

Our Philosophy:
At DRT, we believe in Driving Resolution Together. This principle guides our collaborative approach to addressing our clients' most significant challenges.

Role Support:
The Medical Editor will play a crucial role in delivering on-site editorial support to the FDA Center for Biologics Evaluation and Research (CBER), specifically within the Office of Vaccine Research and Review (OVRR). This position is integral to the FDA's mission of ensuring the availability of safe and effective biologics to the public.

Key Responsibilities:
The Medical Editor will be responsible for:

  • Editing and formatting marketing application reviews, INDs, and Sponsor meeting documents.
  • Collaborating with a team of writers and editors to coordinate with FDA personnel on OVRR's Integrated Review pilot.
  • Ensuring high standards of organization and communication throughout the editing process.
  • Performing thorough copy editing for grammar, punctuation, style, and internal consistency.
  • Conducting literature searches to enhance document content.
  • Executing routine quality checks on the work of fellow medical writers/editors.
  • Managing the organization and updates of the SharePoint site.
  • Verifying documents for Section 508 compliance.
  • Working with FDA stakeholders to establish project requirements, scope, risks, and deliverables.
  • Overseeing task order project management, including financial forecasting.
  • Participating in management activities as defined by the leadership team.
  • Providing overall project support as necessary.

Ideal Candidate:
The successful candidate will possess:

  • Experience in editing and formatting scientific or user fee documents.
  • Strong organizational, time management, and communication skills.
  • The ability to manage a diverse portfolio of projects independently.
  • Proficiency in MS Office and EndNote.
  • Intermediate skills in Microsoft Word, with a willingness to learn advanced features.

Preferred Qualifications:
Additional skills that would be advantageous include:

  • Experience with federal government guidelines or policy documents.
  • Two or more years of copy-editing experience with familiarity in style guides (e.g., AP, Chicago, or AMA).
  • Knowledge of SharePoint, EndNote, and Visual Basic.
  • Understanding of Section 508 compliance.
  • Experience with federal communications and the FDA regulatory process.
  • Ability to comprehend scientific discussions related to drugs, clinical trials, and product labeling.

Education:
A Bachelor's or Master's degree in a STEM discipline is preferred.

At DRT Strategies, we value professionalism, quality, teamwork, customer focus, and growth. Our culture promotes collaboration and transparency, empowering our employees to excel. We are committed to your success and professional development.

DRT Strategies, Inc. is an equal opportunity employer, celebrating diversity and providing equal employment opportunities to all individuals.