Senior ICF Medical Writing Project Manager

Thermo Fisher Scientific
Onsite

About The Position

Leads patient-centric medical writing projects with a primary focus on Informed Consent Forms (ICFs) through collaboration with internal and client teams. Manages project timelines, budgets, and resources. Manages and ensures the timely delivery and the quality of individual projects and documents for internal and external clients. Builds client relationships and identifies and resolves client management issues. Develops, monitors, and adapts project plans, timelines, and budgets/forecasting for assigned projects. Develops project timelines, standards, budgets, forecasts and contract modifications for assigned projects. Serves as liaison with other departments on contract modifications. Collaborates with cross-functional team members as needed to meet the deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, and quality are maintained. Ensures 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 reviewing projects using tracking and management tools. Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline. Ensures compliance with quality processes and requirements for assigned projects both within and between documents within a project. Reviews and manages performance metrics for assigned projects.

Requirements

  • Experience in medical writing, specifically with Informed Consent Forms (ICFs).
  • Project management skills, including timeline, budget, and resource management.
  • Client relationship management experience.
  • Ability to develop, monitor, and adapt project plans.
  • Experience with contract modifications and inter-departmental liaison.
  • Strong communication and team leadership skills.
  • Proficiency in using tracking and management tools.
  • Understanding of quality processes and requirements in medical writing.

Responsibilities

  • Leads patient-centric medical writing projects with a primary focus on Informed Consent Forms (ICFs) through collaboration with internal and client teams.
  • Manages project timelines, budgets, and resources.
  • Manages and ensures the timely delivery and the quality of individual projects and documents for internal and external clients.
  • Builds client relationships and identifies and resolves client management issues.
  • Develops, monitors, and adapts project plans, timelines, and budgets/forecasting for assigned projects.
  • Develops project timelines, standards, budgets, forecasts and contract modifications for assigned projects.
  • Serves as liaison with other departments on contract modifications.
  • Collaborates with cross-functional team members as needed to meet the deliverables of the project.
  • Regularly communicates with the team and leads team meetings to ensure that timelines, resources, and quality are maintained.
  • Ensures 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 reviewing projects using tracking and management tools.
  • Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline.
  • Ensures compliance with quality processes and requirements for assigned projects both within and between documents within a project.
  • Reviews and manages performance metrics for assigned projects.
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