Principal Medical Writer Job at ProPharma Group, United States

  • ProPharma Group
  • United States

Job Description

ProPharma Group seeks a Principal Medical Writer to lead the development of clinical and regulatory documents across the product lifecycle. The role involves managing complex deliverables, supervising junior writers, and collaborating with cross-functional teams to support biotech, pharmaceutical, and medical device clients.

Responsibilities

  • Author and edit high-quality clinical, regulatory, and safety documents across therapeutic areas and development phases
  • Manage clinical program deliverables including protocols, study reports, IBs, ICFs, and submission-level documents
  • Supervise, train, and mentor less experienced medical writers as needed
  • Independently manage client expectations, lead project meetings, and coordinate cross-functional resources
  • Perform quality control reviews, peer reviews, and coordinate audit trails for document changes

Requirements

  • Bachelor's degree or higher, preferably in medical or scientific discipline
  • Minimum 7 years clinical and regulatory document writing experience in pharma, biotech, or CRO
  • Advanced knowledge of FDA regulations, ICH guidelines, and submission requirements
  • Expert proficiency with MS Word, including tables, graphs, and figure management
  • Strong project management and client relationship building capabilities
  • Advanced ability to interpret clinical data and complex scientific information
  • Proficiency in English and familiarity with AMA style

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