Senior Medical Writer — Regulatory Submissions & Leadership

ThermoFisher Scientific; Conscenti; On-site; EUR 70,000 - 100,000; Full time

Job summary

Thermo Fisher Scientific in Europe is expanding its Medical Writing FSP Team. We seek a Senior Medical Writer to develop high-quality clinical and regulatory documents, ensuring regulatory compliance and company standards. This role requires expertise in structured content and project leadership.

You will write and edit study reports, protocols, brochures, and regulatory submissions, collaborate with cross-functional teams, mentor junior writers, and manage project timelines.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent; advanced degree preferred.
• Regulatory writing experience in pharma/CRO (5+ years).
• Experience managing and directing complex medical writing projects.
• EU CTR experience preferred.

Responsibilities

• Write and edit clinical and regulatory documents including study reports and regulatory submissions.
• Collaborate with cross-functional teams to gather information and ensure accuracy of documents.
• Ensure documents comply with regulatory guidelines and company standards.
• Provide input on document content, structure and presentation.
• Mentor and provide oversight to junior medical writers and ensure high-quality deliverables.
• Manage timelines and deliverables for assigned projects.

Skills

Medical writing

Regulatory writing

Leadership

Project management

Education

Bachelor's degree in a scientific discipline

Advanced degree

Tools

Structured Content Authoring tools

Job description

Thermo Fisher Scientific in Europe is expanding its Medical Writing FSP Team. We seek a Senior Medical Writer to develop high-quality clinical and regulatory documents, ensuring regulatory compliance and company standards. This role requires expertise in structured content and project leadership.

You will write and edit study reports, protocols, brochures, and regulatory submissions, collaborate with cross-functional teams, mentor junior writers, and manage project timelines.