Principal Medical Writer

Job Summary

A company is looking for a Principal Medical Writer to prepare and oversee high-quality clinical documents and regulatory submissions.

Key Responsibilities:

• Prepare, edit, and finalize clinical documents and regulatory submissions, integrating inputs from team members
• Manage the document review process and ensure project delivery from outsourced or internal sources
• Collaborate with clinical team members to interpret study results and ensure accurate representation in documents

Required Qualifications:

• Bachelor's degree with 12+ years, Master's degree with 7+ years, or Doctoral degree with 5+ years of relevant medical writing experience
• Proven experience writing INDs, clinical protocols, clinical study reports, and regulatory documents
• Thorough knowledge of clinical research concepts and regulatory guidelines
• Ability to work independently and manage multiple projects under pressure
• Strong computer skills, including proficiency in EndNote or equivalent software