Senior ICF Medical Writing Project Manager

Work Schedule

Environmental Conditions

Job Description

Join Us as a Senior ICF Medical Writing Project Manager (PM) – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Senior ICF Medical Writing PM, you will lead patient-centric medical writing projects with a primary focus on Informed Consent Forms (ICFs) through collaboration with internal and client teams. You will manage project timelines, budgets, and resources, ensuring the timely delivery and quality of individual projects and documents for internal and external clients. You will build client relationships and identify and resolve client management issues. Additionally, you will develop, monitor, and adapt project plans, timelines, and budgets/forecasting for assigned projects.

What You’ll Do:

• Develop project timelines, standards, budgets, forecasts and contract modifications for assigned projects. Serves as liaison with other departments on contract modifications.
• Collaborate 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.
• 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 reviewing projects using tracking and management tools.
• Evaluate and appropriately escalate or resolve risks to project quality, budget, or timeline.
• Ensure compliance with quality processes and requirements for assigned projects both within and between documents within a project. Review and manage performance metrics for assigned projects.

Education and Experience Requirements:

• BS/BA (scientific discipline preferred) with at least 5 years relevant experience or an advanced degree with at least 3 years relevant experience
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Experience in managing medical writing or clinical projects required. Experience managing ICF content is advantageous.
• Experience working in the pharmaceutical/CRO industry preferred.
• Experience in medical writing (eg, Regulatory and/or plain language) advantageous

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:

• Strong project management skills, to include budgeting, forecasting, and resource management.
• Solid planning and organizational skills to enable effective prioritization of workload.
• Excellent interpersonal skills, including problem solving, judgment, and decision-making skills; self-motivated and adaptable
• Effective oral and written communication skills with internal and external stakeholders; strong negotiation skills
• Good knowledge of global, regional, national and other regulatory and document development guidelines relevant to patient-centric deliverables.
• Good judgment; high degree of independence in decision making and problem solving

Working Conditions and Environment:

• Work is performed in a remote office environment with exposure to electrical office equipment.

Why Join Us?

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.

Apply today to help us deliver tomorrow’s breakthroughs.

Originally posted on Himalayas