Indianapolis, Indiana, USA
3 days ago
Clinical Functional Excellence Lead

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

The Opportunity:

This position focuses on process improvement, regulatory compliance, training, and inspection readiness activities across Clinical Operations. You will work with global and regional teams to ensure consistency and compliance with Roche guidelines and international regulations, while aiming to improve both efficiency and quality of the project outcomes.

Responsibilities include:

Implementing process improvement activities in line with Roche processes and international regulations.

Identifying improvement opportunities and amending current processes.

Providing compliance support and advice on regulations such as Roche Code of Conduct, ICH GCP, IVDR, FDA regulations, and GDPR.

Collaborating with partners on a global and local level to drive process improvements.

You will contribute to innovative sustainable solutions in support of establishing a standardized approach and oversight of standard processes

Developing and supporting training programs and materials.

Overall, you'll support standardized processes and continuous improvement initiatives to enhance product development and operational efficiency.

Who you are:

You have a Bachelor's degree

You have 6 years of experience in Clinical Operations environment or in a Quality Function, 

You have 6 years of experience in working in a highly regulated environment

You have 3 years’ experience in working on projects as well as in project management, including global cross-functional projects (i.e. projects in a global matrix)

Preferred Qualifications:

Master's or PhD (preferably in Life Sciences)

Knowledge of applicable standards and regulations for clinical trials ( ICH/GCP, U.S. CFR, GxP, ISO, IVDR, GDPR,, etc.). Solid know how in the Medical Device / IVD business is a plus

Ability to act self-motivated with adequate oversight

Ability to influence multidisciplinary teams and to achieve results, act as change agent

Basic experience in resolving complex issues in a matrix organization 

Strong analytical and decision making skills in a complex, fast paced, and changing environment

Ability to work in global teams, cultural awareness

Ability to interact with and to present to higher hierarchy levels and global audiences

Competency to design and implement cross-functional processes

Expertise in project coordination and management

Advanced Microsoft Office or Google G-suite skills

Willingness and ability to travel regionally or internationally up to 30% of time

The expected salary range for this position based on the primary location of Indianapolis, IN $96,800 - $179,800.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

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