Clinical Development Lead — Medical Writing & Regulatory

Roche; Indianapolis (IN); 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 in driving clinical evidence generation for IVD. You will design study protocols, author CSRs and Investigator Brochures, and manage end-to-end documentation for regulatory submissions across Infectious Diseases, Oncology, and Cardiovascular/Metabolic areas.

You will mentor junior writers, ensure lifecycle management compliance, and collaborate with Medical Affairs and Scientific

Qualifications

• Doctoral or advanced degree in life sciences or related clinical research field
• Proven medical/scientific writing experience in industry or academia
• Experience authoring clinical protocols and reports
• Publications in peer‑reviewed journals
• Strong organizational and cross‑functional communication skills
• Experience with document lifecycle management and regulatory standards

Responsibilities

• Design clinically sound protocols with SMEs to support IVD product development and regulatory filings
• Author, review, and finalize clinical study documents (protocols, CSRs, Investigator Brochures, IVDR docs)
• Synthesize literature and data into regulatory-ready reports
• Manage end-to-end document lifecycle ensuring regulatory compliance
• Collaborate with Medical Affairs and Scientific Communications on manuscripts, posters, and advisory board content
• Mentor junior Medical Writing team and drive process improvements

Education

Doctoral or advanced degree (PhD, MD, PharmD) in life sciences or related clinical research field

Medical writing

Clinical documentation

Project management

Cross-functional collaboration

Tools

Word processing

Document lifecycle management

Collaboration tools

Job description

Roche is seeking a Clinical Development Lead (Medical & Scientific Writing) to partner with the CEI team in driving clinical evidence generation for IVD. You will design study protocols, author CSRs and Investigator Brochures, and manage end-to-end documentation for regulatory submissions across Infectious Diseases, Oncology, and Cardiovascular/Metabolic areas.

You will mentor junior writers, ensure lifecycle management compliance, and collaborate with Medical Affairs and Scientific