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Senior Medical Writer/Principal Medical Writer

1 day, 5 hours ago
Romania
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 QC clinical documents, including protocols, investigator’s brochures, ICF 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 independently.
  • Conduct literature-based research to support medical writing activities.
  • Communicate clearly with internal teams and clients in both written and verbal formats.
  • Contribute to developing and maintaining medical writing processes, SOPs, templates, and work instructions.
  • Apply Precision style guidelines, SOPs, regulatory guidance, and eCTD requirements to all deliverables.
  • Manage multiple high-priority projects and complete assignments accurately and on schedule.

Requirements

  • Bachelor’s degree or equivalent in a scientific or medical discipline with relevant writing experience.
  • 5+ years of experience as a Senior Medical Writer 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 strong problem-solving skills.
  • Ability to work independently with minimal instruction in a fast-paced, multi-project environment.
  • Advanced degree such as an MS or PhD preferred.
  • Oncology or rare disease experience, particularly protocol and CSR development, preferred.
  • Must be legally authorized to work in the country of employment without employer sponsorship.

Interested in this position?

Apply directly on the company website

Apply Now

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