Project Description:The project provides Scientific writing and medical editing support to the FDA Center for Biologics and Research (CBER). The project supports the FDA's mission to ensure that safe and effective biologics are available to the American people.
Job Summary:The Scientific Writer will support FDA CBER review staff prepare post-market memorandum, draft regulatory history, and/or backgrounder documents. Contractor staff will edit and format review memos, manuscripts, and policy documents as well as attend and summarize meetings with FDA stakeholders as needed. The position requires thorough understanding of FDA review process, attention to detail, reliability, consistency, and interaction with FDA stakeholders across several Offices and Divisions.
Responsibilities:- Work with FDA stakeholders in their review of complex scientific documents including post-market memoranda, manuscripts, policy documents, committee briefings, and slide presentations.
- Draft scientific content including study protocols, white papers, presentations, and manuscripts for submission to peer-reviewed journals.
- Perform copy editing for grammar, punctuation, style, and internal consistency.
- Analyze and evaluate the requirements for assigned writing and editing tasks.
- Perform literature searches as needed to assist with editing and revision of document content.
- Draft, Perform routine quality checks on the work of other medical writers/editors.
- Assist in the development of visual communication aids including graphs, figures, and infographics.
- Work with a team of editors and writers to manage document control, edit and format for consistency and one voice.
- Help customers to identify ineffective or inefficient process areas and to make improvement recommendations.
- Assist DRT to identify other areas where our Health Science practitioners can help current and future customers
- Check document for 508 Compliance.
- Work with FDA stakeholders on requirement gathering, project scope, risks and deliverables.
- Assist with overall project support as needed.
Required Experience:- 5+ years of scientific writing and copy-editing experience.
- Experience in synthesizing and disseminating scientific information regarding complex issues, decisions, or policies.
- Familiarity with a style guide (e.g., AP, Chicago, or AMA).
- Excellent organizational, time management, and communication skills, demonstrated experience working independently as well as in a team environment.
- Ability to take scientific meeting minutes and synthesize discussion points for stakeholders
- Computer skills: MS Office and reference software.
- Intermediate experience and/or certification in Microsoft Word with willingness to learn new features.
Preferred Experience:- Prior experience working on vaccines and/or product review process .
- Experience editing guidelines or other policy documents for the federal government.
- Familiarity with SharePoint, EndNote, and Visual Basic.
- Familiarity with 508 compliance.
- Familiarity with FDA regulation of drugs and biological products and EUA and BLA review processes.
- Ability to understand and follow scientific discussion on drugs, side effects, placebo effects, adverse events, and labeling.
Education & Training:- Master's or PhD degree in biomedical sciences
Work Authorization, Clearance Requirement, & Additional Information:- This position requires the ability to obtain and maintain a U.S. government Public Trust clearance. Due to contract requirements, candidates must be U.S. citizens or lawful permanent residents (green card holders) to be eligible.
- No agencies, third parties, or Corp-to-Corp submissions.
Salary Range:- $100,000-$130,000
- Salary commensurate with experience.
