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Senior Medical Writer/Principal Medical Writer

1 day, 5 hours ago
Spain
Full-time
Senior
Technical Writer
Technical Writing and Documentation
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 92

Description

  • Plan, write, edit, format, and perform QC review of protocols, investigator brochures, informed consent templates, DSURs, CSRs, and CSR patient narratives.
  • Manage documents from initial templates through final approval in collaboration with sponsors, vendors, and internal project teams.
  • Formulate key messages from clinical study data and author complex medical content.
  • Communicate clearly with internal and client teams in writing and verbally.
  • Contribute to medical writing processes, SOPs, templates, and work instructions.
  • Conduct literature-based research to support clinical writing activities.
  • Complete multiple high-priority assignments accurately and on schedule.

Requirements

  • BS degree or equivalent in a scientific or medical discipline with relevant writing experience.
  • 5+ years of Senior Medical Writer experience in a sponsor or CRO setting, or 7+ years as a Principal Medical Writer.
  • Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
  • Understanding of ICH, FDA, GCP, clinical trial transparency requirements including EudraCT and ClinicalTrials.gov, and eCTD requirements.
  • Exceptional attention to detail and ability to deliver timely writing assignments.
  • Ability to work independently in a fast-paced environment with multiple high-priority projects.
  • Advanced degree such as an MS or PhD preferred.
  • Oncology or rare disease experience, particularly protocol and CSR development, preferred.
  • Candidates must be legally authorized to work in the country of employment without employer sponsorship.

Benefits

  • Remote work opportunity.
  • Equal opportunity employer.
  • Reasonable accommodations available during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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