Senior ICF Med Writing Project Manager/ICF Program Manager

Thermo Fisher Scientific is a leading company in the healthcare sector, seeking a Senior ICF Medical Writing Project Manager/ICF Program Manager. This role involves leading patient-centric medical writing programs focusing on Informed Consent Forms, managing project timelines, budgets, and resources while ensuring high-quality delivery for clients.

Responsibilities:

• Develop project timelines, standards, budgets, forecasts and contract modifications for assigned projects. Serve as liaison with other departments on contract modifications
• Collaborate with cross-functional team members as needed to meet the deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, and quality are maintained
• Ensure achievement of final deliverables within the contractual time period by preparing and monitoring timelines, providing status updates to the appropriate point of escalation, and regularly review projects using tracking and management tools
• Evaluate and appropriately escalate or resolve risks to project quality, budget, or timeline. Serve as a point of contact for risk escalation for programs managed by junior staff
• Ensure compliance with quality processes and requirements for assigned programs both within and between documents. Review and manage performance metrics for assigned programs, and support management of department-level performance metrics as needed
• Assist business development and senior management on securing new business at program levels by developing and making presentations to clients, leading the development and review of proposal texts and budgets, and supporting contract negotiations
• Provide training for ICF project managers on processes and technical aspects of program management
• Support business development activities by partnering with senior management to secure new business through client presentations, proposal development, budget preparation, and contract negotiations
• Serve as a subject matter expert by providing guidance, mentoring, and training to ICF Project Managers on program management processes and best practices

Requirements:

• BS/BA in a scientific discipline (or equivalent experience)
• At least 5 years of relevant experience
• Experience in clinical or medical writing within the pharmaceutical or CRO industry
• Advanced project management skills, including budgeting, forecasting, and resource management
• Expert planning and organizational skills
• Excellent interpersonal skills including problem solving, judgment, and decision-making skills
• Expert oral and written communication skills with internal and external stakeholders
• Advanced negotiation skills
• In-depth knowledge of global, regional, national and other regulatory and document development guidelines relevant to patient-centric deliverables
• Excellent judgment; high degree of independence in decision making and problem solving
• Capable of mentoring and leading junior level staff
• Advanced degree with at least 3 years relevant experience
• Experience in ICF content and customization (eg, Regulatory and/or plain language)