Senior Medical Writer — Regulatory Docs & Team Lead

ThermoFisher Scientific; Italia; À distance; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Thermo Fisher Scientific is expanding its Medical Writing FSP team in Europe. We seek a Senior Medical Writer to develop high-quality clinical and regulatory documents, ensuring regulatory compliance and company standards.

The role involves writing and editing documents, collaborating with cross-functional teams, and mentoring junior writers while staying up-to-date with industry guidelines and regulatory requirements.

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Regulatory writing experience with pharma/CRO background is expected.
• Advanced degree is a plus and preferred.

Responsabilités

• Write and edit clinical and regulatory documents including CSRs, protocols, IBs, and submissions.
• Collaborate with cross-functional teams to ensure accuracy and completeness of documents.
• Ensure documents align with regulatory guidelines and company standards.

Connaissances

Leadership

Organizational skills

Regulatory knowledge

Communication

Quality control

Independent decision making

Formation

Bachelor's degree in a scientific discipline

Advanced degree preferred

Description du poste

Thermo Fisher Scientific is expanding its Medical Writing FSP team in Europe. We seek a Senior Medical Writer to develop high-quality clinical and regulatory documents, ensuring regulatory compliance and company standards.

The role involves writing and editing documents, collaborating with cross-functional teams, and mentoring junior writers while staying up-to-date with industry guidelines and regulatory requirements.