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Medical Writer

4 hours, 11 minutes ago
United States
Full-time
Junior
Technical Writer
Technical Writing and Documentation
Apply Now
Celerion

Celerion

Celerion is a pioneer in early clinical research, offering Applied Translational Medicine services worldwide to expedite drug development processes.

Pharmaceuticals
251-1K
Founded 2010
View All Jobs 5

Description

  • Analyze and interpret clinical trial safety data, including vital signs, laboratory values, adverse events, ECGs, diagnostic procedures, and pharmacodynamic endpoints.
  • Compile, write, and edit Phase I and Phase II clinical trial documents, including clinical study reports, stand-alone safety narratives, and synoptic CSRs.
  • Review study results to determine whether safety objectives and endpoints were met and reflect findings accurately in safety text.
  • Perform peer quality control checks on safety text for completeness, accuracy, and alignment with the full CSR.
  • Serve as project Report Lead on a multidisciplinary scientific team to ensure quality and on-time delivery of reports.
  • Monitor editorial comments and incorporate only accurate changes that support study objectives and endpoints.
  • Ensure deliverables comply with regulatory standards such as Good Clinical Practice and ICH guidelines, as well as client specifications.
  • Use collaboration tools and platforms to work with international teams.
  • Lead project-related communication with clients and coordinate with internal departments such as data management, project management, and business development.
  • Participate in departmental and market segment team functions as needed.

Requirements

  • Bachelor's degree and/or professional license in a medical or scientific field (RN, BS, RPh, MS, MPH), or equivalent experience.
  • 1-3 years of experience in a hospital or clinical setting, or interpreting medical or clinical results.
  • Professional writing and editing skills for accurate, concise reporting of clinical trial results.
  • Ability to interpret and present data in a coherently written document.
  • Detail-oriented, thorough, and methodical work style.
  • Ability to work independently without close supervision.
  • Ability to work under pressure and manage aggressive timelines.
  • Ability to multi-task and respond rapidly to changing priorities.
  • Excellent communication and interpersonal skills.
  • Knowledge of medical, pharmaceutical, and/or clinical research concepts preferred.

Interested in this position?

Apply directly on the company website

Apply Now

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