Clinical Development Lead - Medical Writing & Strategy

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

Benefits offered by this job

Discretionary annual bonus

Benefits package

Job summary

Roche Holding AG is seeking a Clinical Development Lead (Medical & Scientific Writing) to drive clinical evidence generation for In‑Vitro Diagnostics (IVD) and manage study design across Infectious Diseases, Oncology, and Cardiovascular/Metabolic diseases.

You will author and review critical documents, guide end‑to‑end lifecycle management, and partner with Medical Affairs to deliver regulatory submissions while mentoring junior staff in a collaborative, multi‑disciplinary environment.

Qualifications

• Doctoral or advanced degree in life sciences, pharmacology, biomedical engineering, biostatistics/epidemiology, or related field.
• 2+ years of scientific research and medical/scientific writing experience in industry or academia, with protocol/report authorship.
• Publications in peer‑reviewed journals.
• Strong organizational and project management skills with cross‑functional communication.
• Proficiency in standard word processing and document lifecycle tools.

Responsibilities

• Design clinically sound protocols with SMEs to support IVD development and regulatory filings.
• Author, review, and finalize protocols, CSRs, Investigator Brochures, and IVDR documentation.
• Perform literature reviews and translate complex data into regulatory‑ready reports.
• Lead end‑to‑end document lifecycle management with QA compliance.
• Collaborate with Medical Affairs and Scientific Communications on manuscripts, posters, and advisory content.
• Mentor junior Medical Writing team members and drive process improvements.

Skills

Scientific writing

Project management

Cross‑functional collaboration

Publications

Education

Doctoral or advanced degree in life sciences

Tools

Word processing

Document lifecycle management

Collaboration software

Job description

Roche Holding AG is seeking a Clinical Development Lead (Medical & Scientific Writing) to drive clinical evidence generation for In‑Vitro Diagnostics (IVD) and manage study design across Infectious Diseases, Oncology, and Cardiovascular/Metabolic diseases.

You will author and review critical documents, guide end‑to‑end lifecycle management, and partner with Medical Affairs to deliver regulatory submissions while mentoring junior staff in a collaborative, multi‑disciplinary environment.