Principal Med Writer

Responsibilities

• Serve as primary author on complex clinical, scientific and program-level documents, including IBs, INDs and MAAs

• Research, write and edit clinical study reports and study protocols, and summarize clinical study data

• Provide senior-level review of routine and complex documents

• Train and mentor writers and program managers on document preparation, software, regulatory requirements and therapeutic area knowledge

• Ensure compliance with quality processes and develop best practices and process improvements

• Serve as backup program manager, including timelines, budgets and contract modifications

• Represent the department at project launch, review and team meetings

Requirements

• Expertise in medical and scientific writing

• Knowledge of regulatory document requirements

• Strong collaboration and client communication skills

About the Company

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Its brands include Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.