IVD Clinical Development Lead - Regulatory Writing

Roche; Tucson (AZ); Hybrid; USD 101,000 - 187,000; Full time

Job summary

Roche is seeking a Clinical Development Lead (Medical & Scientific Writing) to partner with the CEI team and drive clinical evidence generation for cutting-edge IVD programs. You will own end-to-end documentation strategy and lifecycle management for regulatory submissions.

You will design protocols, author CSRs and IVDR documents, review literature, mentor junior staff, and collaborate with Medical Affairs to produce manuscripts and posters. Flexible hybrid work in AZ/USA.

Qualifications

• Doctoral or advanced degree in life sciences or related field
• Minimum 2 years of scientific research and medical writing experience
• Proven publications in peer-reviewed journals

Responsibilities

• Design protocols for novel IVD product development and regulatory filings
• Author and review clinical study documents including CSRs and IVDR reports
• Review literature and synthesize data into regulatory-ready reports
• Manage end-to-end document lifecycle ensuring regulatory compliance
• Collaborate with Medical Affairs and Scientific Communications on manuscripts and posters
• Mentor junior Medical Writing team members

Skills

Scientific writing

Project management

Cross-functional collaboration

Document lifecycle tools

Education

Doctoral or advanced degree in life sciences

Tools

Document lifecycle management

Job description

Roche is seeking a Clinical Development Lead (Medical & Scientific Writing) to partner with the CEI team and drive clinical evidence generation for cutting-edge IVD programs. You will own end-to-end documentation strategy and lifecycle management for regulatory submissions.

You will design protocols, author CSRs and IVDR documents, review literature, mentor junior staff, and collaborate with Medical Affairs to produce manuscripts and posters. Flexible hybrid work in AZ/USA.