Senior Medical Writer — Regulatory & Clinical Documentation Lead

ThermoFisher Scientific; España; A distancia; EUR 65.000 - 95.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is expanding its Medical Writing FSP team in Europe. We seek a Senior Medical Writer to develop high-quality regulatory documents for a client in the FSP space, with experience in structured content authoring and automation to support delivery.

The role involves leading complex medical writing projects, mentoring junior writers, and ensuring compliance with regulatory requirements and company standards across clinical study reports and regulatory submissions.

Formación

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• 5+ years regulatory writing experience in pharma/CRO environments.
• Experience developing clinical/regulatory documentation compliant with guidelines.
• Ability to lead complex medical writing projects and mentor peers.

Responsabilidades

• Write and edit clinical and regulatory documents including CSRs, protocols, investigator brochures, and submissions.
• Collaborate with cross-functional teams to gather information and ensure accuracy of documents.
• Ensure alignment with regulatory guidelines and company standards in all deliverables.
• Provide input on document content, structure, and presentation.
• Review documents prepared by others and provide actionable feedback.
• Manage timelines and deliverables for assigned projects.
• Mentor junior medical writers and ensure high-quality outputs.

Conocimientos

Regulatory writing

Clinical trial docs

Protocol writing

Cross-functional collaboration

Mentoring junior writers

Educación

Bachelor's degree in a scientific discipline

Advanced degree preferred

Descripción del empleo

Thermo Fisher Scientific is expanding its Medical Writing FSP team in Europe. We seek a Senior Medical Writer to develop high-quality regulatory documents for a client in the FSP space, with experience in structured content authoring and automation to support delivery.

The role involves leading complex medical writing projects, mentoring junior writers, and ensuring compliance with regulatory requirements and company standards across clinical study reports and regulatory submissions.