Clinical Development Lead: Medical & Scientific Writing

Roche; Wien; Vor Ort; EUR 82.000 - 117.000; Vollzeit

Zusammenfassung

Roche Diagnostics Solutions (RDS) seeks a Clinical Development Lead to manage documentation across clinical studies and regulatory submissions. You will work with CDMA SMEs to design, write, and review protocols, CRFs, and study reports, ensuring compliance with IVDR/IVD standards.

You will guide clinical evidence generation, liaise with Medical Affairs for scientific content, and mentor colleagues while driving process improvements within the CEI team.

Qualifikationen

• Doctoral or advanced degree in life sciences or related field.
• Proven scientific writing experience in clinical or regulatory documents.
• Experience with regulatory writing for IVDs or medical devices is preferred.

Aufgaben

• Oversees and manages the entire document lifecycle, ensuring timely delivery of high-quality documents per Roche procedures.
• Co-develops clinically sound studies with SMEs from CDMA and other functions.
• Participates in project teams to support clinical study design, protocol and report generation, and results review.
• Supports clinical evidence generation by aligning product portfolio with IVD Regulation requirements.
• Mentors less experienced CEI team members and drives process improvements.

Kenntnisse

Scientific writing

Regulatory writing

Clinical research

Project coordination

Ausbildung

Doctoral degree or equivalent (PhD/MD/PharmD)

Jobbeschreibung

Roche Diagnostics Solutions (RDS) seeks a Clinical Development Lead to manage documentation across clinical studies and regulatory submissions. You will work with CDMA SMEs to design, write, and review protocols, CRFs, and study reports, ensuring compliance with IVDR/IVD standards.

You will guide clinical evidence generation, liaise with Medical Affairs for scientific content, and mentor colleagues while driving process improvements within the CEI team.