DRAFT Scientific_Writer-Editor 1223991 SOW v1.pdf

Reference:

Request for Information - FDA-RFI-1223991

DRAFT PERFORMANCE WORK STATEMENT

SCIENTIFIC DESKTOP PUBLISHING AND EDITING SERVICES

1. BACKGROUND

The Directors for the Office of Regulatory Science (ORS), the Office of Applied Research and Safety Assessment (OARSA), the Office of Food Additive Safety (OFAS) and the Office of Food Safety (OFS) for the Center for Food Safety and Applied Nutrition (CFSAN) have employed a number of new Scientists. As a result, there is a need for Scientific Writers to support CFSAN’s effort to increase its’ production of scientific publications and abstracts. Scientific Writer support will help to facilitate the messaging efforts of CFSAN Research Scientists.

In order to implement the required editorial support within ORS, OARSA, OFAS and OFS, highly qualified scientific writers are needed to develop, write, and edit content for publications and abstracts for which our scientists will be submitting their request for approval through their respective Office Directors or designees. A minimum of one writer will be needed for ORS, OARSA and OFAS in the College Park area, and a second writer will be needed for the Office of Food Safety at their Moffet Tech Center in Bedford Park, IL.

The contractor shall provide two writers. One for ORS, OARSA, OFAS and one for OFS.

2. OBJECTIVES

The objectives of this effort are to provide the ORS, OARSA, OFAS and OFS with:

• Scientific Writer-editor services in written communications.

• Technical and scientific writing to support commercial, clinical research and academic audiences.

• Services and expertise in writing using plain language and writing for the web for industry, consumers and targeted audiences.

• Services and expertise in editing scientific publications and abstracts in various documents and ensuring suitability for intended audience.

• Services and support for improved scientific publications and abstracts with communication and coordination with other program areas within the organization.

3. SCOPE OF WORK

ORS, OARSA, OFAS and OFS requires additional contractor support to provide services to enhance and expand scientific publications/abstract materials in various formats (that are determined by the publications or scientific organization) to convey current research.

4. TASKS

The contractor shall:

o Develop, technical and scientific writing and edit information to support commercial, clinical research and academic audiences.

o Collaborate with Subject Matter Experts (SME) and Project Officer to ensure that information is clear and accurate for the scientific community.

o Ensure that written materials meet Agency guidelines and standards, including plain language and web writing guidelines.

o Write and/or edit informational materials, then analyze the subject matter of the informational material for the purpose of ensuring that the informational materials can be understood by the intended audience.

o Collaborate with program and staff to develop and approve material to be posted on the FDA and/or CFSAN web sites or scientific web sites.

o Progress Reports o The Contractor shall provide bi-weekly status reports which document the work/taskings completed, the activities performed during that reporting period, and the activities planned for the next reporting period. The Contractor should be available to discuss with the COR any current or anticipated performance problems and suggest mitigation strategies to address performance risk.

o Every 6 months, the Contractor shall provide a semi-annual report that summarizes the work that has been accomplished, and any barriers to success that have been observed.

5. DELIVERABLES

Reference

Deliverables

Frequency

Article 3, Scope of Tasks

Provide bi-weekly progress reports to COR by the 15th and 30th of the month. If these days fall on a weekend the reports are due on the following Monday.

Bi-weekly

Same as above Provide semi-annual report Every 6 months

All written deliverables shall be delivered in electronic format with read/write capability compatible with Microsoft Office Suite application.

6. PLACE OF PERFORMANCE

Performance site is defined as:

FDA Wiley Building

5001 Campus Drive

College Park, Maryland 20740.

FDA Division of Food Processing Science and Technology (DFPST)

Moffett Tech Center

6502 S. Archer Road

Bedford Park, IL 60502

7. GOVERNMENT FURNISHED EQUIPMENT/PROPERTY/INFORMATION (GFE/GFP/GFI)

The Government will provide the workspace, equipment and supplies, necessary to perform the services required in this SOW. The Contractor shall use the Government furnished resources only in performance of defined work effort. As determined by the COR, the contract staff may work in an alternate work space, or telework from home.

8. PERIOD OF PERFORMANCE

Base Year July 16, 2020 – July 15, 2021 Option Year 1 July 16, 2021 – July 15, 2022 Option Year 2 July 16, 2022 – July 15, 2023 Option Year 3 July 16, 2023 – July 15, 2024 Option Year 4 July 16, 2024 – July 15, 2025

10. CONTRACTOR SECURITY REQUIREMENTS

The Contractor shall obtain security clearances for new staff as required by the attached Contractor

Security Requirements attached.

11. Labor Category Definition

LABOR CATEGORY NO. 1 - SCIENTIFIC WRITER/EDITOR

Duties and Responsibilities: Highly qualified scientific writers are needed to develop, write, and edit content for publications and abstracts for which our scientists will be submitting their request for approval through their respective Office Directors or designees.

o Develop, technical and scientific writing and edit information to support commercial, clinical research and academic audiences.

o Collaborate with Subject Matter Experts (SME) and Project Officer to ensure that information is clear and accurate for the scientific community.

o Ensure that written materials meet Agency guidelines and standards, including plain language and web writing guidelines.

o Write and/or edit informational materials, then analyze the subject matter of the informational material for the purpose of ensuring that the informational materials can be understood by the intended audience.

o Collaborate with program and staff to develop and approve material to be posted on the FDA and/or CFSAN web sites or scientific web sites.

o Progress Reports o The Contractor shall provide bi-weekly status reports which document the work/taskings completed, the activities performed during that reporting period, and the activities planned for the next reporting period. The Contractor should be available to discuss with the COR any current or anticipated performance problems and suggest mitigation strategies to address performance risk.

o Every 6 months, the Contractor shall provide a semi-annual report that summarizes the work that has been accomplished, and any barriers to success that have been observed.

Qualifications: 1) Bachelors degree with a major in a scientific discipline such as chemistry, physics, biology, mathematics, or related fields; or bachelor’s degree with demonstrated experience in scientific and technical writing about a scientific discipline such as chemistry, physics, biology, mathematics, or related fields; 2) 5 or more years of work experience in technical or scientific writing.