Senior ICF Med Writing Project Manager/ICF Program Manager

About the role

Join our expert team as a Senior ICF Medical Writing Project Manager/ICF Program Manager, where you will lead patient-centric medical writing programs with a focus on Informed Consent Forms (ICFs). You will collaborate with internal and client teams, manage project timelines, budgets, and resources, and ensure the timely delivery and quality of complex document programs. This role involves building client relationships, resolving client management issues, and serving as a subject matter expert and mentor to junior staff.

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 to meet project deliverables.
• Lead team meetings and ensure timelines, resources, and quality are maintained through regular communication.
• Ensure final deliverables are achieved within the contractual time period by monitoring timelines, providing status updates, and reviewing projects using tracking and management tools.
• Evaluate and escalate or resolve risks to project quality, budget, or timeline, including serving as a point of contact for risk escalation for programs managed by junior staff.
• Ensure compliance with quality processes and requirements for assigned programs.
• Review and manage performance metrics for assigned programs and support department-level performance metrics.
• Assist business development and senior management in securing new business by developing client presentations, proposal texts, budgets, and supporting contract negotiations.
• Provide training for ICF project managers on processes and technical aspects of program management.
• Serve as a subject matter expert by mentoring and training ICF Project Managers on program management processes and best practices.

Requirements

• BS/BA (scientific discipline preferred) with at least 5 years of relevant experience or an advanced degree with at least 3 years of relevant experience.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Experience in managing clinical or medical writing (or similar) projects required.
• Experience working in the pharmaceutical/CRO industry required.
• Experience in ICF content and customization (e.g., Regulatory and/or plain language) preferred.
• In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient.

Skills

• Advanced project management skills, including budgeting, forecasting, and resource management.
• Expert planning and organizational skills to enable effective prioritization of workload.
• Excellent interpersonal skills, including problem-solving, judgment, and decision-making; self-motivated and adaptable.
• 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.

Working Environment

This role operates in an office environment with a standard Monday to Friday work schedule. Thermo Fisher Scientific values the health and wellbeing of our employees and supports a healthy and balanced work environment.

Benefits

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.