Medical Editor CDER

• Work with a team of editors and writers to manage document control edit and format for consistency and one voice; work with FDA stakeholders in their review of complex scientific documents including reviews of new drug applications policy documents committee briefings and slide presentations
• Perform copy editing for grammar punctuation style and internal consistency
• Perform literature searches to assist with editing and revision of document content
• Perform routine quality checks on work done by fellow medical writers/editors
• Manage SharePoint site organization and updates
• Check document for Section 508 compliance
• Work with FDA stakeholders on establishing project requirements scope risks and deliverables
• Oversee task order project management including financials and forecast
• Participate in management activities as defined by management team
• Assist with overall project support as needed

• Ability to take meeting notes and synthesize into major discussion points
• Excellent organizational time management and communication skills
• Ability to independently manage a diverse portfolio of projects to complete work in a timely manner and meet mandatory deadlines despite frequent interruptions and shifting priorities
• Computer skills: MS Office
• Intermediate experience and/or certification in Microsoft Word with willingness to learn advanced features

• Experience editing guidelines or other policy documents for the federal government
• 2 years of copy-editing experience and familiarity with a style guide (e.g. AP Chicago or AMA)
• Familiarity with SharePoint EndNote and Visual Basic
• Familiarity with Section 508 compliance
• Experience preparing drug applications in the pharmaceutical industry
• Ability to understand and follow scientific discussion on drugs clinical trials adverse events treatment effects and product labeling
• Familiarity with FDA regulatory process

• Bachelors degree (STEM disciplines preferred)

• 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.

• $60000-$75000
• Salary commensurate with experience.

DRT Strategies Inc. (DRT) follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race color religion sex (including pregnancy childbirth or related conditions transgender status and sexual orientation) national origin age genetic information disability protected veteran status or any other protected characteristic under federal state or local law.

Reasonable accommodations for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact Human Resources by emailing or by dialing .

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