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Senior Medical Writer

1 hour, 20 minutes ago
Canada
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 145

Description

  • Plan, write, edit, format, and perform quality control review of clinical study documents.
  • Develop clinical documents in compliance with the Precision MW Style Guide, Precision SOPs, regulatory guidelines, and eCTD requirements.
  • Lead document management from template development through final approved version in collaboration with sponsors, vendors, and internal teams.
  • Author key clinical documents including protocols, investigator brochures, informed consent form templates, DSURs, CSRs, and CSR patient narratives.
  • Formulate key messages from clinical study data independently.
  • Write complex content based on study data, processes, and regulatory requirements.
  • 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.
  • Handle 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 medical writer in a sponsor and/or CRO setting.
  • Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
  • Clear understanding of applicable regulations such as ICH, FDA, and GCP.
  • Knowledge of clinical trial transparency requirements, including EudraCT and CT.gov.
  • Knowledge 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 with minimal instruction on new assignments.
  • Advanced degree (MS/PhD) preferred.
  • Oncology and/or rare disease experience, especially in protocol and CSR development, preferred.

Benefits

  • Salary range of $101,800 to $152,600.
  • Discretionary annual bonus.
  • Health insurance.
  • Retirement savings benefits.
  • Life insurance and disability benefits.
  • Parental leave.
  • Paid time off for sick leave and vacation.

Interested in this position?

Apply directly on the company website

Apply Now

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