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Senior Medical Writer/Principal Medical Writer

1 month ago
United Kingdom
Full-time
Senior
Technical Writer
Technical Writing and Documentation
GCP
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 48

Description

  • Plan, write, edit, format, and perform QC review of clinical study documents.
  • Develop clinical documents in compliance with company style guides, SOPs, regulatory guidelines, and eCTD requirements.
  • Manage documents from template through final approved version in collaboration with sponsors, vendors, and internal teams.
  • Independently formulate key messages from clinical study data.
  • Author complex clinical content using established processes and judgment.
  • Communicate clearly and concisely with internal and client teams.
  • Contribute to the development and maintenance of medical writing processes, SOPs, templates, and work instructions.
  • Perform literature-based research to support writing activities.
  • Complete assigned writing tasks on time and with strong attention to detail.
  • Perform other duties as assigned.

Requirements

  • BS degree or equivalent in a scientific or medical discipline with relevant writing expertise.
  • 5+ years of experience as a Senior Medical Writer in a sponsor and/or CRO setting, or 7+ years of experience as a Principal Medical Writer.
  • Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
  • Clear understanding of applicable regulations including ICH, FDA, and GCP.
  • Knowledge of clinical trial transparency requirements, including EudraCT and CT.gov.
  • Understanding of eCTD requirements for all phases of development.
  • Impeccable attention to detail and ability to complete writing assignments in a timely manner.
  • Ability to work effectively in a fast-paced environment with multiple high-priority projects.
  • Advanced degree (MS/PhD) preferred.
  • Oncology and/or rare disease experience, especially in protocol and CSR development, preferred.

Interested in this position?

Apply directly on the company website

Apply Now

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