[Hiring] Principal Medical Writer @Parexel

Role Description

As a Principal Medical Writer, you'll play a critical role in developing high-quality clinical and regulatory documents that support drug development programs. Beyond writing, you'll have opportunities to lead projects, build strong client relationships, mentor colleagues, and help shape best practices across our Medical Writing organization.

What You'll Do

• Lead Clinical and Regulatory Writing
  • Research, develop, write, and edit high-quality clinical and regulatory documents.
  • Lead complex medical writing projects, ensuring scientific accuracy, regulatory compliance, and timely delivery.
  • Prepare key clinical documents, including Clinical Study Reports (CSRs), Investigator's Brochures (IBs), and Informed Consent Forms (ICFs).
• Drive Project Leadership and Collaboration
  • Serve as a lead medical writer, submission coordinator, and primary client contact, as appropriate.
  • Coordinate contributions from multiple writers and cross-functional stakeholders.
  • Manage project priorities, timelines, and deliverables while maintaining high-quality standards.
• Build Relationships and Influence
  • Develop trusted relationships with clients and internal partners.
  • Collaborate with stakeholders to align expectations, resources, and project objectives.
  • Provide medical writing expertise to support proposals and new business opportunities.
• Mentor and Innovate
  • Share your expertise through mentoring, training, and knowledge sharing.
  • Identify opportunities to improve medical writing processes, efficiency, and quality.
  • Contribute to a culture of collaboration, continuous learning, and innovation.

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, or a related discipline, or equivalent qualifications.
• Strong understanding of clinical research, drug development, and applicable regulatory guidelines.
• Extensive experience preparing clinical and regulatory documentation, particularly CSRs, IBs, and ICFs.
• Demonstrated experience managing complex medical writing projects.
• Knowledge of resource planning and productivity management.
• Advanced proficiency in Microsoft Word and familiarity with document management systems, SharePoint, Excel, and related technologies.
• Fluency in written and spoken English.

Requirements

• Leadership: Ability to guide projects, collaborate across teams, and support the development of others.
• Communication: Exceptional written, verbal, interpersonal, and negotiation skills.
• Adaptability: Ability to navigate changing priorities, embrace new challenges, and quickly learn new processes and technologies.
• Collaboration: Comfortable working in a global, matrixed environment with diverse teams and stakeholders.
• Problem-Solving: Sound judgment, proactive thinking, and a solutions-oriented approach.
• Client Focus: Ability to build trusted relationships, understand client needs, and deliver high-quality results.
• Organization: Strong attention to detail and the ability to balance multiple projects and competing priorities.

Benefits

• Make a meaningful impact: Contribute to clinical research that helps bring innovative treatments to patients worldwide.
• Lead with expertise: Take ownership of complex medical writing projects and play a key role in regulatory documentation and submissions.
• Collaborate globally: Partner with talented medical writers, cross-functional teams, and clients across the life sciences industry.
• Influence and innovate: Share your knowledge, mentor colleagues, and contribute to continuous improvement.
• Enjoy flexibility: Work remotely from Canada while contributing to meaningful global clinical development initiatives.