Principal Regulatory Writer

Pharsight   •  

Cary, NC

Industry: Biotech/Pharma


11 - 15 years

Posted 396 days ago

Position Overview



  • Work closely with client, internal, and partner organization teams to lead development of strategies for organizing and preparing regulatory documents

  • Lead a project team comprised 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 resolutions 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.



Reporting Structure

  • Principal Regulatory Writers report to a Team Lead

  • Team Leads report directly to the CEO



Skill Requirements


  • BA/BS (minimum)

  • 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 able 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


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