Senior Medical Writer, Global Regulatory & Oncology

Worldwide Clinical Trials; Italia; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading clinical research organization in Italy is seeking a Senior Principal Medical Writer to prepare and lead the development of Phase I-IV study documents. The ideal candidate has a degree in life sciences, at least 4 years of medical writing experience, and excellent English skills. This role involves project management, regulatory compliance, and collaboration across departments. Opportunities for training and career development are provided.

Competenze

• 4+ years of experience as a Medical Writer or equivalent.
• Thorough knowledge of regulatory requirements and guidelines.
• Ability to interpret data clearly.

Mansioni

• Prepare and lead the medical writing team on Phase I-IV study documents.
• Develop Pre-IND documents and briefing books.
• Manage document templates according to global regulations.

Conoscenze

Excellent written and spoken English

Project/time management

Microsoft Office skills

Flexibility with deadlines

Formazione

University/college degree in life sciences or related

Strumenti

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Descrizione del lavoro

A leading clinical research organization in Italy is seeking a Senior Principal Medical Writer to prepare and lead the development of Phase I-IV study documents. The ideal candidate has a degree in life sciences, at least 4 years of medical writing experience, and excellent English skills. This role involves project management, regulatory compliance, and collaboration across departments. Opportunities for training and career development are provided.