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.
As a Global Quality & Regulatory, Regulatory Intelligence Product Owner, you are accountable for the Regulatory Intelligence tool landscape. You ensure the tools support the modular framework and comply with applicable and regional regulatory requirements, influencing Senior Leaders and key stakeholders supporting the acceptance and adoption of the global Regulatory Intelligence tools. You primarily support the Regulatory Radar Platform in all aspects of product ownership.
The Opportunity
- You serve as a single voice representing the OneRoche Regulatory Intelligence Coalition (PD/PT/Dia) to the RegRadar Change Control Board, facilitate decisions and priorities, and qualify requests from the user community
- You act as a bridge between the users (OneRoche Regulatory Intelligence Coalition), IT/ALM, and the vendor (Johner Institute) to drive gathering and tracking of features that need to be developed or enhanced in response to bugs/user feedback or strategic business needs. This includes prioritizing the system changes impacting users across the OneRoche Regulatory Intelligence coalition, and discussing other major issues or adoption needs
- You proactively interact with cross-functional users while providing consistent communication with various functions. There is a key focus on managing the relationship with the business at both a strategic and portfolio level to ensure the IT organization has early insight into changing business directions in order to inform and shape IT demand
- You act as a product owner and work closely with IT, SMEs, partnering business units, and other applicable stakeholders in the planning and design of application implementations, changes and coordinating on delivery and deployment processes. As an evangelist, this position stays abreast of functional and development tools, trends, and practices that should be considered for future initiatives
- You globally influence the acceptance and realization of the tools across all Roche Sites & Affiliates, ensuring the delivery of the objectives as an enabler to the Roche ten-year Strategy. You are accountable for ensuring that our tools meet CSV and company standards and expectations throughout the global organization including operations, development, and affiliate sites.
- You collaborate with DIA, Pharma PT and Pharma R&D business areas and other relevant colleagues to align on needs, opportunity identification, and priority to develop, enhance, and/or deploy system solutions via the Regulatory Radar platform.
- Together with the IT Solution Owner and IT Project Manager, you host backlog prioritization discussions to align on current business priorities. You support the translation of business requirements to technical understanding for the Johner team. Additionally, you manage the weekly Power User Group (PUG) sessions to foster development alignment between Roche functions (DIA, Pharma PT and Pharma R&D) to deliver the OneRoche initiatives, facilitate sprint planning and review biweekly discussions with cross-functional stakeholders
- You are ultimately responsible for the validated state of the Regulatory Radar Platform computerized system. You utilize Agile methodology to further develop and deploy the Regulatory Radar Platform for the highest business value. You are accountable for ensuring that the computerized system (hosted internally by Roche or externally) is fit for its intended use; that procedures are in place for computerized system use; that data is secure from unauthorized access and/or changes; and that the supplier has an adequate quality management system.
Who You Are
- You have a Bachelor’s / Master's degree in Life Science, Pharmacy or related subject; Advanced degree is considered an advantage
- You hold at least five(5) years in the Medical Device/Pharma/Biopharmaceutical industry working in Quality, Compliance, Regulatory and/or Validation, preferred or equivalent experience
- You have experience with Agile/ Waterfall methodologies / Software Development Life Cycle (SDLC) process experience
- You have excellent knowledge of the European, US, China and International cGMP regulations and demonstrated ability to adequately interpret and implement quality standards. You hold business-level fluency in English
- You bring practical experience in digital transformation, technology, and system solution governance. And you demonstrate the ability to thrive in a dynamic global environment where you will meet the challenge to bring new ideas and concepts, structured thinking, facilitation, execution, and focus to the work of automating and simplifying service provider oversight for users
Locations:
You are based out of Indianapolis, Santa Clara, Branchburg, Pleasanton, Basel, Mannheim, Sant Cugat, Penzberg, Kaiseraugst.
At the companies’ discretion, an exception to the location requirement may be made under extraordinary circumstances.
Relocation assistance is not available for this position.
The expected salary range for this position based on the primary location of Indiana is $99,400 - $184,600. 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.
As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. These products and services are used by researchers, physicians, patients, hospitals and laboratories worldwide to help improve people's lives.
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.
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.