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Senior Medical Writer

1 week, 6 days ago
United States
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 132

Description

  • Plan, write, edit, format, and perform QC review of clinical study documents, including protocols, IBs, ICF templates, DSURs, CSRs, and CSR patient narratives.
  • Lead document development from template creation through final approved version in collaboration with sponsors, vendors, and internal project teams.
  • Independently formulate key messages from clinical study data.
  • Author complex content using scientific and process knowledge.
  • Communicate clearly and concisely with internal and client teams, both in writing and verbally.
  • Contribute to the development and maintenance of medical writing processes, SOPs, templates, and work instructions.
  • Perform literature-based research to support writing activities.
  • Complete medical writing work in compliance with Precision style guides, SOPs, regulatory guidelines, and eCTD requirements.
  • Handle other assigned duties as needed.

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, 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, with no instruction on routine work and 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 $100,600 to $151,000 USD.
  • Eligible for a discretionary annual bonus.
  • Health insurance coverage.
  • 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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