Project manager - Medical Writing

As a Project Manager in Medical Writing, you lead and develop a capable team to deliver compliant, high-quality medical writing outputs within sponsor partnerships. You align with clinical development objectives and collaborate across functions to shape document development strategies and schedules. You will oversee budgets, timelines, and process improvements while maintaining strong client relationships. This role offers impact across drug development by driving efficient, compliant documentation and cross-functional coordination.

• career development programs
• inclusive culture
• training in technical/therapeutic areas
• supportive line management
• total rewards program

• Supervise staff and develop direct reports through goal setting, performance reviews, and coaching
• Set priorities, allocate department resources, and align with company objectives
• Advise on HR processes including hiring, onboarding, and development
• Manage team medical writing deliverables per SOPs and ensure quality and completeness
• Lead cross-functional writing teams and proactively address issues
• Review statistical analysis plans and tables/figures for accuracy
• Support development and implementation of document development strategies and quarterly updates
• Assist with budgets, timelines, revenue, invoicing, and forecasting
• Contribute to planning, writing, and assembling medical writing deliverables
• Develop and maintain SOPs and templates; serve as implementation resource
• Build and maintain internal and external customer relationships
• Track and review department metrics; support business development activities
• Travel may be required
• Perform other duties as assigned

• Bachelor’s degree in a relevant scientific/medical field
• ≥6 years of progressive medical writing experience
• 1 year of management/supervisor experience preferred
• Management experience in an CRO or pharmaceutical/medical device company preferred
• Excellent English grammar; knowledge of FDA, EU, ICH, ISO regulations
• Familiar with clinical research principles and medical writing processes
• Strong relationship-building and leadership abilities; ability to train and supervise staff
• Ability to organize, prioritize, and schedule work
• Strong communication, presentation, and interpersonal skills
• Proficiency in Microsoft Office Suite

• Strong communication and interpersonal skills
• Leadership and team-building
• Ability to influence and persuade
• Microsoft Office Suite
• medical writing processes, systems, procedures, and best practices
• regulatory knowledge (FDA, EU, ICH, ISO)