At Roche you can show up as yourself, embraced for the unique qualities you bring. The culture encourages personal expression, open dialogue and genuine connections, where you are valued, accepted and respected.
The Position
At Roche Diagnostics Solutions, the mission is to diagnose earlier, develop faster and personalise treatment because every patient is unique. The Clinical Development and Medical Affairs team drives innovation to improve healthcare outcomes globally.
The Clinical Development Lead is an integral member of the Clinical Development Clinical Evidence In-Vitro Diagnostics team at Roche Diagnostic Solutions. The role provides documentation support for clinical study documents, including reports, protocols, clinical study reports, investigator brochures and IVDR performance evaluation documents. The position functions as a strategic partner within Clinical Development to support clinical evidence generation and clinical study design of in vitro diagnostics for registration with regulatory agencies.
The Opportunity
- Oversee and manage the entire document lifecycle and ensure timely delivery of high quality documents in accordance with Roche procedures, regulatory requirements, quality systems and journal requirements.
- Co-develop scientifically sound clinical studies with subject matter experts from Clinical Development and Medical Affairs and other functions to support new product development.
- Participate in project teams to support clinical study design and execution activities, including protocol and report generation and critical review of study results.
- Support clinical evidence generation by analyzing the product portfolio across a customer area and creating documentation to support compliance with IVD regulation.
- Conduct comprehensive literature reviews, collate clinical and scientific information and create new scientific content with minimal guidance.
- Partner with Medical Affairs Scientific Communications to provide writing support for manuscripts, posters and advisory boards.
- Share best practices with the Clinical Evidence team, support process improvement activities and manage collaborative work tools, quality control, automation opportunities and reference libraries.
- Manage timelines, projects, processes and cross-functional meetings while building strong relationships and leading several projects to completion.
- Act as a mentor to less experienced team members.
- Maintain clinical, regulatory and scientific expertise related to IVD product development and regulatory documentation.
- Provide medical and scientific input into regulatory submissions and responses to regulatory agency reviewers.
Who are you
- You have a doctoral or advanced degree, such as PhD, MD or PharmD, in life sciences, pharmacology, biomedical engineering, biostatistics, epidemiology, clinical research or another related field.
- You have solid experience in scientific research and proven scientific writing experience in an academic or industry setting with clinical or regulatory documents, including clinical study protocols and reports.
- You have experience with regulatory writing for in vitro diagnostics or medical devices, including companion diagnostics, preferred.
- You have an understanding of laboratory techniques in areas such as PCR, sequencing, serology, microbiology, clinical virology, immunohistochemistry or immunological assays, preferred.
- You have an understanding of basic statistical techniques, preferred.
Who we are
A healthier future drives Roche to innovate. More than 100000 employees across the globe are dedicated to advancing science and ensuring access to healthcare today and for generations to come.
Vollzeit
Forschung & Entwicklung