Medical Writing Operations Manager

About the role

The Manager, Medical Writing Operations leads document support within the medical writing team, authoring and coordinating regulatory, clinical, and safety documents. This role emphasizes operational excellence, process improvements, and training team members in a dynamic, patient-focused environment.

Responsibilities

• Lead advanced document formatting, template development, and compliance with regulatory standards (FDA, EMA, ICH).
• Manage timelines and review cycles to ensure submission-ready, scientifically accurate documents.
• Collaborate with cross-functional teams to produce high-quality regulatory, clinical, and safety documents.
• Drive process improvements and operational excellence within the medical writing team.
• Train and mentor team members on best practices and tools.

Requirements

• Bachelor’s degree in a related field.
• 6+ years of relevant experience in medical writing or regulatory document support.
• Expertise in Microsoft Word, document management systems, and regulatory requirements.

Skills

• Strong project management and communication skills.
• Exceptional attention to detail.
• Ability to work collaboratively in cross-functional teams.

Benefits

• Competitive compensation and benefits package.
• Opportunities for professional growth in a patient-focused environment.