[Hiring] Medical Writing Program Manager @Thermo Fisher Scientific

Role Description

This role involves providing oversight to a client-dedicated document review and publishing team. Key responsibilities include:

• Acting as the primary point of contact for client needs and concerns
• Ensuring a high level of client satisfaction
• Managing and allocating resources effectively, including staffing and technology
• Supporting development, monitoring, and adapting project plans, timelines, and forecasts for complex review activities
• Serving as the client point of contact for risk escalation
• Ensuring compliance with quality processes and requirements for assigned programs
• Developing, reviewing, and managing performance metrics for assigned projects
• Providing senior-level review of document review materials
• Training new reviewers on processes and technical aspects of document review
• May serve as primary reviewer for regulatory documents

Qualifications

• Bachelor's degree in a scientific discipline or equivalent; Advanced degree preferred
• 8+ years of relevant experience
• Experience in document review or medical writing required for CSR, Protocol, ICF, IB, and other Regulatory Submission Documents
• Experience in allocating resources preferred
• Experience working in the pharmaceutical/CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Requirements

• Solid project management skills including resource management and timeline development
• Excellent data interpretation and medical writing skills
• Extensive knowledge of global, regional, national, and other document development guidelines
• Excellent oral and written communication skills with strong presentation skills
• Excellent negotiation skills
• Self-motivated and adaptable
• Excellent judgment; high degree of independence in decision making and problem solving
• Ability to mentor and lead entry-level staff

Benefits

• Award-winning learning and development programme
• Competitive salary
• Extensive benefits package focused on health and well-being
• Flexible working culture promoting work-life balance
• Collaborative environment with a focus on sharing expertise