Principal Medical Writer (Regulatory)

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations. The position offers the opportunity to strengthen responsible execution, improve decision-making, and support sustainable growth within a healthcare environment.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Lead and manage completion of medical writing assignments with high accuracy
• Draft and finalize a range of regulatory documents including clinical study protocols and IND submissions
• Ensure adherence to regulatory standards and internal guidelines during document preparation
• Coordinate and conduct quality reviews of medical writing deliverables
• Act as a peer reviewer to ensure scientific clarity and consistency in documents
• Provide feedback on statistical analysis plans and documentation needs
• Mentor and guide less experienced medical writers to enhance their skills

Qualifications

• 5+ years of experience in medical writing, particularly in regulatory documentation
• Strong understanding of ICH E3 guidelines and regulatory standards
• Proven ability to manage diverse medical writing deliverables simultaneously
• Excellent technical writing and editing skills with attention to detail
• Demonstrated ability to mentor junior writers and lead complex projects
• Strong interpersonal skills for client and internal team interaction

Benefits

• Opportunity for professional development and continued education
• Exposure to a variety of therapeutic areas and compliance standards
• Engagement with multidisciplinary teams across the organization
• Guidance and mentorship roles for career advancement
• Possible participation in industry conferences and collaborative projects

Pay

$110,000 – $130,000 annually