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

Senior Regulatory Writer

Responsibilities

  • Lead or participate in a project team that may be led by a Principal Regulatory Writer or Associate Principal Regulatory Writer, depending on document type or therapeutic experience
  • Author documents per client specifications, templates, style guides, and other guidance documents
  • Author documents per regulatory authority guidelines and requirements
  • Act as a client point of contact
  • Manage budget for respective project or 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
  • Lead or participate in project-related meetings and teleconferences

Experience Required

  • Experience writing study-level documents in their entirety and the ability to lead/own a study-level document
  • Collective experience writing a range of study-level documents for various clients:
    • Investigator’s Brochure
    • Protocol
    • Clinical Study Report — abbreviated and synoptic
    • Pharmacokinetic Reports
    • QT Studies
    • Observational and Non-interventional Reports
  • Experience in the development of submission-level documents (does not require functioning as a document lead):
    • Briefing Packages
    • IND/CTA/IMPD
    • NDA/BLA/MAA/NDS

Skill Requirements

  • BS/BA
  • At least 3–5 years of regulatory writing experience with nonclinical, clinical, CMC, or drug safety–related documentation
  • Strong understanding of the document creation process and of clinical development and study-level clinical operations from conceptual study design to final CSR/CTR
  • Ability to analyze clinical data and present it in a written format
  • Ability to conduct/lead a CRM and successfully lead a project team to consensus
  • Ability to provide high-quality customer service and follow-through on all assignments
  • Excellent Microsoft Word skills and document management techniques
  • Professional, personable demeanor
  • Strong interest in a writing/editing role

Reporting Structure

  • Senior 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