Clinical Pharmacologist Writer

• Assist CBER/OBPV staff in preparing first drafts/multiple drafts of responses to requests for information on biologics from a variety of sources including the public, academia, the media, and government sources. The writers will edit responses prepared by CBER staff to ensure they are concise, clear, and suitable for the intended audience.
• Support the development of scientific manuscripts including study protocols, white papers, presentations, and manuscripts for submission to peer-reviewed journals. Examples include protocols at and a recently published article at
  
  
  
  
• Assist in the development of visual communication aids including graphs, figures, and infographics.
• Assist CBER/OBPV staff in reviewing and interpreting data analyses and suggest additional analysis.

• A minimum of least 3 years’ experience in pharmacoepidemiology studies using large health claims databases or electronic health records systems.
• Excellent writing skills and experience with document preparation, together with strong formatting, editing, and organization skills.
• Experience in synthesizing and disseminating information regarding complex issues, decisions, or policies.
• project management skills to plan, organize and coordinate numerous projects and time sensitive assignments.
• Capable computer skills to execute the tasks required by the position; knowledgeable about scientific and document preparation software: Word, Excel, PowerPoint, or similar reference software.

• Familiarity with FDA regulation of drugs and biological products and EUA and BLA review processes.
• Familiarity with Section 508 requirements for reader accessibility.

• Post Doctorate Degree in Pharmacology

• 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.

• $80,000-105,000
• 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 View email address on us.fitly.work, or by dialing View phone number on us.fitly.work.

For additional information, please review the Know Your Rights: Workplace Discrimination is Illegal , E-Verify (English) , E-Verify (Spanish) . Right to Work (English) , Right to Work (Spanish) .

Please be aware of recruitment fraud where malicious individuals might pose as DRT Strategies. Only job postings and emails from drtstrategies.com are authentic and legitimate communications regarding DRT Strategies employment opportunities. Please contact Human Resources at View email address on us.fitly.work if you believe you have received a fraudulent email.