Sr. Technical Information Specialist

Description

MPF has an immediate need for a full-time, Senior Technical Information Specialist (STIS) for one of our Federal Government contracts in Silver Spring, MD. The position is 100% on site during normal core business hours (7:30 am – 5:30 pm), Monday through Friday. 

The qualified candidate will be responsible for clerical and administrative duties for managers and staff, including assisting with office operations, projects, and special assignments. The candidate will also 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 managers and staff.

· Coordinate logistical details associated with office operations such as supplies inventory, timekeeping, travel preparation, data entry, and maintaining filing systems for a wide variety of records, both manually and electronically.

· Assist in moving office equipment and managing supply rooms.

· 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. 

o Review and check the document against the FDA style guides and make corrections to documents as needed.

o Correct any formatting inconsistencies such as table and chart titling and numbering. 

o Add internal bookmarking to facilitate navigation of scientific materials and references.

o Ensure conformance with FDA style guides, consistent numbering of figures and charts, and consistent formatting. Identify and correct inconsistencies in formatting, numbering, references, etc. 

• Review regulatory incident reports, extract pertinent information as required, and perform data entry into government database. 

• Coordinate printing, collation, and dissemination of printed copies of briefing materials for meetings. 

• Provide 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:

• Assist in a variety of administrative matters including supply inventory, timekeeping, travel preparation, data entry, and      maintaining filing systems for a wide variety of records (both manually and electronically).
• 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 a government website.
• Work with program staff to revise documents for narrative, organization, and clarity.
• Prepare documents and materials for scanning, digitization, printing, collating, and disseminating copies of materials.
• Gather information from various sources.

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.
• Experience using office equipment, including fax, copier, and scanner.
• Must be able to lift up to 35 lbs.
• 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.