Medical Editor - FDA

Kaiva Tech, LLC is seeking a Medical Editor in the DC Metro Area.

Clearance: Ability to obtain a Public Trust

Workplace Type: Currently 100% remote due to COVID. Please be aware that the workplace type allowed is approved by the client and is subject to change dependent on client needs and expectations.

Summary Overview:

The Medical Editor will support scientists at the US Food and Drug Administration (FDA) who regulate gene therapy, cell therapy, tissue transplantation and other biological treatments for human diseases. The Medical Editor will format and proofread documents written by FDA scientists, format data tables, and create new data tables using data derived from regulatory submissions to the FDA. The position requires the ability to use a style guide to apply language and formatting standards, and a willingness to learn advanced features of Microsoft Word. Preferred candidates will have education or experience in a scientific or healthcare field.

Essential Duties and Responsibilities:

As a Medical Editor your responsibilities will include, but are not limited to the following:

• Formatting and proofreading documents written by FDA scientists.
• Becoming familiar with a style guide and applying formatting and language standards consistently; making decisions regarding elements of style not mentioned in the style guide and apply such decisions uniformly throughout a document.
• Identifying errors in grammar, spelling, punctuation; correct tone, flow, verb tense, and style.
• Recognizing and correcting inconsistent use of scientific terms used in text or data tables.
• Using Microsoft Word styles and field-coded captions to ensure the functionality of automated tables of contents and lists of tables and figures.
• Inserting and managing citations and references; creating lists of abbreviations and ensuring correct use of acronyms and abbreviations within documents.
• Formatting data tables; creating and populating data tables using data derived from regulatory submissions to the FDA.
• Creating and maintaining consistently formatted document templates.
• Communicating efficiently and effectively with FDA scientists regarding requirements and timelines for editing projects.
• Performing routine quality checks on work performed by other copy editors.
• Providing support for the onboarding and training of new copy editors as needed.
• Creating and maintaining internal documents such as style guides, process documents, and training materials.

Required Experience and Skills:

• Adept with English grammar, spelling, punctuation.
• Ability to read and understand a data table.
• Familiarity with Microsoft Word including track changes.
• Attention to detail (e.g., ability to recognize an extra space between words or in the cell of a data table).

Desired Experience and Skills:

• Work experience as a copy editor.
• Savvy with Microsoft Word features such as styles, captioning, and cross-referencing.
• Experience in healthcare, laboratory, or pharmaceutical industry.
• Ability to understand medical literature such as journal articles.
• Ability to fact-check scientific writing and data.
• Familiarity with a style guide (e.g., AP, AMA).
• Familiarity with Section 508 compliance.
• Experience with Visual Basic, SharePoint, EndNote, Adobe Acrobat, Excel, PowerPoint.

Education:

• Bachelor's Degree required.
• Bachelor's Degree in a Scientific or Health Field preferred.

Certificates, Licenses and Registrations:

• None.

Physical Requirements:

• Ability to sit and work with a computer for prolonged periods of time.

The above statements are intended to describe the general nature and level of work being performed by the individual(s) assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required. Kaiva Corporation reserves the right to modify, add, or remove duties and to assign other duties as necessary. In addition, where applicable and available, reasonable accommodation(s) may be made to enable individuals with disabilities to perform essential functions of this position. Kaiva Corporation is a proud Equal Opportunity Employer! All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability or veteran status.

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