Senior Medical Writer

1 hour, 2 minutes ago
Full-time
Senior
Technical Writing and Documentation
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

Description

  • Plan, write, edit, format, and quality-check 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 creation through final approved version in collaboration with sponsors, vendors, and internal teams.
  • Independently formulate key messages from clinical study data.
  • Author complex content for key clinical documents.
  • 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, 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

  • Annual discretionary 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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