Principal Medical Writer - Clinical Focus

For our client, we are seeking a Principal Medical Writer - Clinical Focus to join the team of a leader in the Pharmaceuticals & Biotech space. This role will lead the development of high-quality clinical and regulatory documents that support programs across multiple phases of development. The Principal Medical Writer will synthesize complex data into clear, accurate submissions and partner closely with cross-functional teams to ensure deliverables meet quality, timeline, and budget expectations. This is an opportunity to shape critical documentation work in a highly regulated life sciences environment while mentoring less experienced writers. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $132,000 – $151,000 annually Responsibilities Prepare high-quality documentation for regulatory submissions Lead projects and author documents across multiple service lines Mentor junior writers in regulatory document authoring Synthesize data to create comprehensive summary reports Manage teams for deliverables, ensuring timelines and budgets are met Qualifications Bachelor's degree or higher 7+ years of regulatory writing experience with clinical-related documentation In-depth understanding of regulatory requirements across various phases of development Knowledge of global health authority requirements Experience leading the authorship of diverse clinical documents in their entirety Benefits Remote working options Flexible time off policies Paid holidays Medical insurance coverage Tuition reimbursement opportunities Retirement plans availability Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.