Regulatory Medical Writing Program Lead

ThermoFisher Scientific; España; Remote; EUR 70,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Program Manager within our Regulatory Medical Writing team to lead client programs and ensure timely, high-quality program documents. You’ll drive timelines, budgets, and processes across multiple projects with global engagement and senior leadership visibility.

The role emphasizes operational excellence, client relationship management, and mentoring of junior staff, with responsibilities spanning proposal development, risk assessment, and training for

Qualifications

• Bachelor's degree in a scientific discipline or equivalent.
• 8+ years of experience in medical writing project management.
• Experience in managing complex medical writing projects.
• Experience in pharma/CRO industry preferred.
• AMWA; EMWA; RAC qualifications advantageous.

Responsibilities

• Develop project timelines, standards, budgets, forecasts and contract modifications for assigned projects. Serves as liaison with other departments on contract modifications.
• 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.
• Serve as point of contact for risk escalation for assigned programs. Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline.
• Ensure compliance with quality processes and requirements for assigned programs both within and between documents within a project. Develops, reviews and manages performance metrics for assigned projects.
• Provide training for medical writers on processes and technical aspects of program management.
• May serve as backup medical writer. Duties could include researching, writing and editing clinical study reports and protocols, summarizing data from clinical studies, writing or providing input on complex clinical and scientific documents such as IBs, INDs, and MAAs, and providing senior review of project materials.

Skills

Program management

Budgeting

Forecasting

Client engagement

Risk management

Quality processes

Leadership

Communication

Mentoring

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Thermo Fisher Scientific is seeking a Program Manager within our Regulatory Medical Writing team to lead client programs and ensure timely, high-quality program documents. You’ll drive timelines, budgets, and processes across multiple projects with global engagement and senior leadership visibility.

The role emphasizes operational excellence, client relationship management, and mentoring of junior staff, with responsibilities spanning proposal development, risk assessment, and training for