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Principal Regulatory Writer

Responsibilities

  • Work closely with client, internal, and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
  • Lead a project team consisting of internal and client team members as well as partner organizations
  • Serve as a liaison and subject-matter expert for clients, guiding and advising them on strategies and best practices for achieving approval from regulatory authorities
  • Author documents per client specifications, templates, style guides, and other guidance documents
  • Author documents per regulatory authority guidelines and requirements
  • Manage overall budget for respective project, including all contributing writers and editors
  • Usher documents through the review process, conduct comment resolution meetings (CRMs)
  • Maintain collaborative, proactive, and effective communication with both client and internal teams
  • Lead project-related meetings and teleconferences
  • Provide training of writing staff and ensure compliance with company standard operating procedures (SOPs) and staff training requirements

Skill Requirements

  • BA/BS
  • 10+ years of regulatory writing experience with nonclinical, clinical, CMC, or drug safety–related documentation
  • Shown success in Word skills and document management techniques
  • Collective experience writing a range of study-level documents in their entirety and ability to lead/own a study-level document
  • 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
  • Professional, personable demeanor
  • Strong interest in a writing/editing role

Reporting Structure

  • Principal 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