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

Associate Principal Regulatory Writer

Responsibilities

  • Work closely with client, internal, and partner organization teams for the development of strategies for organizing and preparing regulatory documents
  • As part of project teams, actively participate in development and writing of high-quality documents, such as CSRs, briefing books, and clinical summaries
  • 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
  • Adhere to SOPs for quality document preparation, document review, accurate comment resolution/incorporation, and document finalization

Skill Requirements

  • Ability to synthesize data and present it in a written format
  • Shown success in Word skills and document management techniques
  • Understanding of document creation process and ability to lead/own a study level document
  • Collective experience writing a range of study-level documents in their entirety and able to lead/own a study-level document:
    • Investigator’s Brochures
    • QT Studies
    • Protocols
    • PK Reports, observational and non-interventional
    • Phase 1–3 Clinical Study Reports, abbreviated and synoptic
  • Strong understanding of clinical development and study-level clinical operations from conceptual study design to final CSR/CTR
  • Ability to conduct/lead a comment resolution meeting and successfully lead a project team to consensus
  • Understanding of regulatory requirements for different phases of development and different regulatory pathways and knowledge of global health authority requirements
  • Has led the development of one or some types of submission-level documents within the CTD:
    • Common technical document sections (SCS/SCE, ISS/ISE)
    • Briefing Packages
    • IND/CTA
    • NDA/BLA/MAA/ NDS

Requirements

  • BA/BS required
  • 8+ years of regulatory writing experience with nonclinical, clinical, CMC, or drug safety-related documentation
  • Professional, personable demeanor
  • Ability to provide high-quality customer service and follow-through on all assignments

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