Write the next chapter of your career and help us lead the transformation of R&D.

Regulatory Writer

You will be trained to

  • Participate on project teams that may be led by a Principal Regulatory Writer, Associate Principal Regulatory Writer, or Senior Regulatory Writer
  • Author documents per client specifications, templates, style guides, and other guidance documents
  • Provide clinical review for patient narratives and other documents
  • Act as a client point of contact
  • Manage a budget for a project or a task within a project
  • Usher documents through the review process, conduct comment resolution meetings (CRMs)
  • Maintain collaborative, proactive, and effective communication with both client and internal teams
  • Participate in project-related meetings and teleconferences

Skill Requirements

  • BS/BA
  • Professional, personable demeanor
  • Ability to provide high-quality customer service and follow-through on all assignments
  • Ability to analyze clinical data and present it in a written format
  • Familiarity with Microsoft Word
  • Strong interest in writing/editing

Reporting Structure

  • Regulatory Writers report to a Team Lead
  • Team Leads report directly to the CEO

The Ideal Candidate

  • Is a team player who enjoys collaboration
  • Desires challenges, both technical and interpersonal
  • Is flexible with an extremely high level of attention to detail

Opportunity and Value for the Right Candidate

  • Variety — submission-level work across therapeutic areas
  • Flexibility — custom schedules and benefits of “flex time”
  • Stability — almost 30 years in business
  • Support — a community of writers working as a team
  • Excellent potential for growth and advancement
  • Excellent compensation