Demo

Sr. Technical Information Specialist

Puente de Vida LLC
Silver Spring, MD Full Time
POSTED ON 1/30/2025
AVAILABLE BEFORE 4/28/2025

Job Type

Full-time

Description

MPF Federal has an immediate need for a full-time, Technical Editor (STIS) for one of our Federal Government contracts in Silver Spring, MD. The position is mostly remote but may require the candidate to report to site occasionally.

The qualified candidate will be responsible for reviewing scientific documents, editing documents to ensure content accuracy, format documents for consistency and standard layout (adhering to style guides), apply bookmarking, and preparing files for scanning and duplication. Additionally, the candidate will be preparing briefing packages and materials for meetings including printing, collating, and dissemination of materials and providing other clerical and document preparation and support as needed.

Position Summary :

  • Provide clerical and administrative support to prepare scientific documents, memos and other supporting documentation for reviews and briefings at various FDA committee meetings and briefings.
  • Review, quality check, and compile briefing packages, scientific memos, and other materials that will be made available to the public on FDA's website at the time of or before the advisory committee meeting.
  • Review and check the document against the FDA style guides and make corrections to documents as needed.
  • Correct any formatting inconsistencies such as table and chart titling and numbering.
  • Ensure conformance with FDA style guides, consistent numbering of figures and charts, and consistent formatting. Identify and correct inconsistencies in formatting, numbering, references, etc.
  • Gather additional information regarding incident reports identified as compounding (current and those pending in the backlog).
  • Create PDF of briefing packages and add internal bookmarking for briefing packages to facilitate navigation of scientific materials and references.
  • For in-person meetings, coordinate printing, collation, and dissemination of printed copies of briefing materials.
  • Provide other clerical and document preparation support as needed to ensure that all meeting materials are available for the public and attendees.
  • Prepare physical documents / files for imaging. Image document / files using FDA supplied hardware and software.
  • Produce duplicate copies of records material.

Job Responsibilities :

  • Ensure conformance with received style guides, consistent numbering of figures and charts, and consistent formatting. Identify and correct inconsistencies in formatting, numbering, references, etc.
  • Create PDF documents from multiple sources, add bookmarks to facilitate navigation of scientific materials and references
  • Provide clerical and administrative support to prepare scientific documents, memos and other supporting documentation for reviews and briefings at various meetings and for availability on FDA's website
  • Work with program staff to revise documents for narrative organization and clarity, and communicates further revisions as needed
  • Prepare documents and materials for scanning, digitize, print, collate, and disseminate copies of materials
  • Gather information from various sources
  • Provide other clerical and document preparation support, including organizing and structuring technical documents for user comprehension and navigation
  • Requirements

    Position Requirements :

    Education and Related Experience

  • Bachelor's degree in a scientific field is required.
  • Minimum of 3 years of experience in analyzing, classifying, and interpreting regulatory submissions.
  • Proficiency in Office 365 applications and Adobe Acrobat.
  • Excellent verbal and written communication skills, along with outstanding customer service abilities.
  • Eligibility to work in the United States and the ability to obtain a government security clearance.
  • Editing, Proofreading, and Collaboration

  • Strong ability to review and edit technical documents for grammar, spelling, and clarity, including conducting research to verify technical information as needed.
  • Expertise in ensuring documents conform to division-specific style guides and subject-matter-specific vocabulary.
  • Proficiency in formatting and editing across various document types (PDF, Word, Excel), including updating references, tables, charts, numbering systems and applying bookmarks
  • Demonstrated experience with Microsoft Word's Review functions, including Track Changes and Comments.
  • Background in quality control processes, document tracking, inventory management, and Must have experience in quality control, overseeing document tracking databases, inventorying records, and scanning is highly desirable
  • Must be highly self-motivated, organized, skilled at time management, and extremely detailed oriented with strong ability to perform quality checks on the work being performed
  • Must complete assignments adhering to all FDA / Federal rules, regulations, policies, guidance documents, and procedures
  • Work Hours : Normal business hours; Monday - Friday, 7 : 00 - 5 : 30 pm / Flexible
  • MPF Federal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.

    Salary Description

    48,000-$51,000

    Salary : $48,000 - $51,000

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