Senior Medical Writer

2 hours, 57 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 perform QC review of clinical study documents.
  • Develop clinical documents in compliance with company style guides, SOPs, regulatory guidelines, and eCTD requirements.
  • Write key clinical documents including protocols, investigator brochures, informed consent form templates, DSURs, CSRs, and CSR patient narratives.
  • Manage documents from template 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 verbally and in writing.
  • 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 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 such as 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 on time.
  • Ability to work effectively in a fast-paced environment with multiple high-priority projects.
  • Ability to work with no instruction on routine work and minimal instruction on new assignments.
  • Preferred: advanced degree (MS/PhD).
  • Preferred: oncology and/or rare disease experience, especially in protocol and CSR development.

Benefits

  • $100,600 to $151,000 USD annual salary range.
  • Eligible for a discretionary annual bonus.
  • Health insurance benefits.
  • 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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