EMEA Regulatory Medical Writing Program Manager

ThermoFisher Scientific; Polska; Hybrid; PLN 180,000 - 300,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Program Manager in Regulatory Medical Writing to lead client programs with high visibility, manage relationships, and ensure timely, high-quality delivery of program documents. The role involves developing project plans, budgets, and processes, and may include acting as a backup medical writer for complex reports and protocols.

Candidates should have a scientific degree and extensive experience in medical writing project management within the pharma/CRO

Qualifications

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

Responsibilities

• Develop project timelines, budgets, forecasts and contract modifications for assigned projects.
• Serve as liaison with other departments on contract modifications.
• Assist senior management on securing new business by presenting to clients and reviewing proposals.
• Manage risks and escalate issues to protect project quality, budget, and schedule.
• Provide training for medical writers on processes and program management.
• May serve as backup medical writer, drafting or editing clinical study documents.

Skills

Budgeting

Forecasting

Resource management

Communication

Negotiation

Mentoring

Decision making

Education

Bachelor's degree in a scientific discipline

Advanced degree

Job description

Thermo Fisher Scientific is seeking a Program Manager in Regulatory Medical Writing to lead client programs with high visibility, manage relationships, and ensure timely, high-quality delivery of program documents. The role involves developing project plans, budgets, and processes, and may include acting as a backup medical writer for complex reports and protocols.

Candidates should have a scientific degree and extensive experience in medical writing project management within the pharma/CRO