Senior Global Regulatory Medical Writing Program Manager

ThermoFisher Scientific; Brussel Hoofdstad; On-site; EUR 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific in Belgium is seeking a Regulatory Medical Writing Program Manager to lead high-visibility client programs within our Regulatory Medical Writing team. You will guide project plans, timelines, budgets and quality for multiple programs, ensuring operational excellence and timely deliverables.

You will develop processes, mentor medical writers, manage risks and client relationships, and collaborate with cross-functional teams to support proposals, negotiations and ongoing

Qualifications

• Bachelor's degree in a scientific discipline or equivalent; advanced degree preferred.
• 8+ years of relevant experience in medical writing or regulatory programs.
• Experience managing complex medical writing projects in pharma/CRO is required.
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.

Responsibilities

• Develop project timelines, standards, budgets, forecasts and contract modifications for assigned projects.
• Assist business development and senior management on securing new business at program levels with client presentations and budgets.
• Serve as point of contact for risk escalation and resolve risks affecting quality, budget or timeline.
• Ensure compliance with quality processes and requirements for assigned programs and manage performance metrics.
• Provide training for medical writers on processes and program management.
• May serve as backup medical writer for writing/editing clinical study reports and protocols.

Skills

Program management

Budgeting

Forecasting

Client engagement

Risk management

Mentoring

Communication

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Thermo Fisher Scientific in Belgium is seeking a Regulatory Medical Writing Program Manager to lead high-visibility client programs within our Regulatory Medical Writing team. You will guide project plans, timelines, budgets and quality for multiple programs, ensuring operational excellence and timely deliverables.

You will develop processes, mentor medical writers, manage risks and client relationships, and collaborate with cross-functional teams to support proposals, negotiations and ongoing