Global Regulatory Information Management (RIMS) Business Lead
The Pharma Development Regulatory (PDR) and Pharma Technical Regulatory (PTR) organizations develop and maintain the licenses that permit Roche to market and sell its life improving therapies worldwide. We are the stewards of the quality, safety and efficacy of medicines, collaborating with regulators of every country in which Roche does business to help them understand our products' clinical value. We also work across the industry and with regulators to continually evolve regulatory policy. We are an organization of ~1200 staff with our main offices in the UK, Switzerland, Germany, Canada, the USA and China.
The end-to-end submission process is a critical accountability for regulatory within the Pharma value chain. It is increasingly important to ensure reduced time and cost of submissions in an increasingly competitive environment, while maintaining quality and compliance. Process, data and technology optimization are key enablers for this ongoing transformation.
This is a great chance to drive a program with a duration of approximately three years. As the Regulatory Information Management (RIM) System Business Lead you will lead the strategy and implementation efforts to deliver the new RIM platform across Regulatory (PDR, PTR and Regulatory Affiliates).This will include data, processes, technologies, and ways of working.
For this interesting role you will bring your many skills to the table, including leadership, strategic execution, program management, and partner management. In addition, the program will be run utilizing an agile methodology.
Who you are:
- Work closely with the Global RIM Project Sponsors, RSC Steering Committee, and IT project manager/owner(s) on all aspects of project delivery, enterprise data strategy as well as the communication of the overall value proposition of the RIM.
- Provide agile leadership to the global team (PTR, PDR, DRA, Pharma IT) to ensure plans are executed in alignment with project objectives
- Together with technology and/or scaling partners develop comprehensive business strategies and timelines to support implementation of the Global RIMS project as well as analyze risks and issues as they arise and develop strategic solutions
- Drive harmonization of business processes, leveraging technology-enabled opportunities for streamlining
- Conduct or direct cost-benefit analyses, and other supporting research as required to develop pragmatic approaches that appreciates the needs of people, process, systems and enabling data.
- Coordinate and run global projects meetings with team members and partners at all levels of the organization
- Collaborate with external training providers and coordinate activities supporting the execution of the plan(s)
- Identify, select, retain, manage vendor partners that may aid in delivering our RIM platform
- Oversight of budgets, management of direct, contractor and consulting staff
- Work closely with the vendor to agree on and drive the implementation strategy for the program
- Drive OCM activities such as continuous stakeholder communication and team readiness for participation at all key milestones as defined by the project
- Interface with external Vendors and other providers to coordinate activities supporting the execution of the plan(s) including base process alignment and data migration strategy
- Work in close collaboration with local, regional, and global senior partners to align on our desired future state, harmonize business processes, drive data clean-up and migration strategy and guide organizational readiness for change
- Create a compelling RIM vision for the future and cascade that throughout regulatory functions (PDR, PTR and DRAs) and cross-functional stakeholders with appropriate messaging for strategic partners through to end-users.
- Collaborate with resource managers internal and external to regulatory to secure the talent required to mobilize and execute the portfolio of initiative
- Build, coach, motivate and challenge a high-impact team of talented SMEs and program area leaders responsible for delivering the RIM releases, including data and process readiness from planning through to data migration, testing, training and ongoing commissioning after go-live.
- Create and empower agile decision-making teams of process SMEs to define new business processes and support the rapid configuration and prototyping of new system within technology boundaries.
- Nimbly support the team as it interfaces to "moving targets" as the enterprise continues to evolve process and technology solutions in the areas of Quality and Supply Chain as well as other regulatory initiatives
You have a strong leadership presence, you have outstanding influencing and negotiation skills and you enjoy running multiple business initiatives in an entrepreneurial environment? Then this position is a good fit for you!
Moreover you have the following qualifications:
- A deep history of prior business experience (10+ years) in the biotechnology, pharmaceutical arena, or related industry is required
- At least 5 years program management experience, with exposure to the design and administration of business strategy development and execution
- Experience of leading large cross functional programs with a technology element
- Knowledge of Regulatory Affairs is highly valued but not required
- Outstanding time management and organizational skills, with an ability to consistently execute multiple, and sometimes competing activities to a high quality and timely conclusion
This position requires international travel up to 50%.
This role can be located in Basel (Switzerland) or San Francisco (US).
Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.
If you have questions then please check our FAQs and videos on careers.roche.ch/faq.
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