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Black Canyon ConsultingBlack Canyon ConsultingBethesda, MD

Technical Communication Specialist

Technical communications expert maintaining ClinicalTrials.gov public content, developing educational resources like guides and webinars, responding to user inquiries, and ensuring regulatory compliance for clinical trial registration and results reporting. Requires strong technical writing skills and experience with scientific or regulatory programs.

Salary not listed
On-siteTechnical Writing

About the role

Responsibilities

  • Manage and maintain ClinicalTrials.gov Protocol Registration and Results System (PRS) account requests.
  • Maintain and update ClinicalTrials.gov public website content.
  • Serve as a primary resource for users regarding registration, results submission, and regulatory requirements.
  • Respond to daily customer inquiries submitted through the ClinicalTrials.gov support channels.
  • Perform quality assurance reviews of database support materials and public documentation.
  • Develop and maintain Frequently Asked Questions (FAQs), policies, operating procedures, and style guides.
  • Collaborate with software developers to implement enhancements to public-facing content and educational materials.
  • Create and maintain user guides, tutorials, webinars, and training materials.
  • Analyze customer feedback using tools such as Google Analytics, Qualtrics, or similar platforms to improve user experience.
  • Coordinate with technical teams, customer support staff, and leadership to communicate new database functionality and policy changes.
  • Support FOIA requests and data calls related to ClinicalTrials.gov.
  • Manage Office of Management and Budget (OMB) Paperwork Reduction Act documentation associated with ClinicalTrials.gov.

Requirements

  • Bachelor's degree in Communications, Technical Writing, Information Science, Health Sciences, Computer Science, or a related field (or equivalent experience).
  • Experience supporting online content for scientific, healthcare, or regulatory programs.
  • Experience developing technical documentation for web-based applications.
  • Excellent written and verbal communication skills.
  • Demonstrated ability to translate complex technical concepts into user-friendly documentation.
  • Experience collaborating with software developers and technical teams.
  • Strong customer service skills supporting diverse user communities.
  • Experience performing quality assurance reviews of online documentation and web content.
  • Ability to prioritize multiple projects in a dynamic environment.

Nice-to-Haves

  • Experience with ClinicalTrials.gov Protocol Registration and Results System (PRS), FDAAA 801, 42 CFR Part 11, NIH policies governing clinical trial registration and reporting, digital analytics tools such as Google Analytics or Qualtrics, scientific or biomedical information systems, or technical communications supporting federal regulatory programs.
  • Strong analytical and problem-solving abilities.
  • Exceptional attention to detail.
  • Ability to develop policies, procedures, and educational materials.
  • Experience working with cross-functional technical teams.
  • Ability to communicate effectively with both technical and non-technical audiences.
  • Experience supporting scientific or biomedical databases.
  • Ability to manage multiple priorities while maintaining high quality standards.

Skills

Technical WritingTechnical DocumentationUser GuidesFaqsWeb Content ManagementCustomer SupportGoogle AnalyticsQualtricsRegulatory ComplianceQuality AssurancePolicy Development

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