Senior Regulatory Writer - Montreal, Canada
Certara, L.P
Montreal, QC, CA
5d ago

Responsibilities

  • Lead or participate in a project team which 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 resolutions 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
  • BS / BA
  • Preferred but not required - 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
  • The Ideal Candidate

  • Is reliable, professional and discrete, and personable with business acumen
  • Is a team player who is flexible with an extremely high level of attention to detail and enjoys collaboration
  • Is deadline conscious with strong leadership and management of process
  • Is self-motivated and solution-driven
  • Can manage changing and competing priorities in a fast-paced environment
  • Desires challenges, both technical and interpersonal
  • Opportunity and Value for the Right Candidate

  • Make an immediate contribution
  • Be a critical driver to overall company success
  • Variety submission-level work across therapeutic areas
  • Flexibility custom schedules and benefits of flex time
  • Stability more than 30 years in business
  • Support a community of writers working as a team
  • Grow excellent potential for growth and advancement
  • Learn gain valuable knowledge and expertise for development and advancement (training provided); the ever-evolving pharmaceutical and biotech industries, and a niche segment, that is growing exponentially.
  • Competitive compensation and benefits package
  • Apply
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