Pop Science is delighted to offer the position of Business Process Expert (BPE) in the area of Regulatory Intelligence to lead requirements analysis of systems which re-define how they operate in regulatory affairs.

You will be based in Basel Switzerland and working on global, cross divisional, strategic initiatives with the mandate to deliver GxP compliant solutions.
You will join a highly skilled team from Regulatory Service Delivery function to deliver on the vision to globally distributed stakeholders within regulatory affairs in different divisions.

As The Business Process Expert you have a key role in describing and translating business requirements in a way that they are clear, complete and easily understood by the business and other relevant stakeholders.
The Business Process Expert is actively involved in pre-project discussions, solution design discussions, to ensure the implementation fulfills the business requirements with a key focus on purpose, consistence and usability.

You will have an excellent technical background within the Pharmaceutical/ Clinical Research Industry as well as proven business analysis techniques and exceptional interpersonal skills.

Here is an idea of what you will be doing :

• Develop project rationale and perform scoping assessments to determine feasibility of projects
• Highlight/identify gaps in existing functionality and review requirements with stakeholders
• Develop a comprehensive requirement specifications that will determine the estimate of cost, time and resources to deploy solutions
• Liaise with the service development team to suggest a high level functional solution
• Support in the development of project estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.)
• Ensure consistency and traceability between user requirements, functional specifications and testing & validation. Support validation and testing (OQ, PQ, UAT...)
• Ensure implemented solutions are according to specifications and fit for purpose.
• Support super user training
• Keep abreast with industry best practices in leveraging technologies for the business and with regulatory environments / requirements if applicable.
• Take accountability to ensure adherence with Security and Compliance policies and procedures within Service Delivery scope
• Work with Business and Process architecture teams to understand "as-is" and define "to-be" processes

MUST HAVE Skills and Experience

• EXTENSIVE experience in SDLC and system validation
• COMPETANT EXPERIENCE WITHIN Drug Development domain
• Held a business analyst/process role over a number of years
• Certified Six Sigma Green Belt or Similar
• Expert understanding of business process analysis & design and system architecture concepts
• Expert knowledge of IT solutions across the industry
• Solid knowledge of Project Management
• Ability to manage medium size teams
• Good negotiation and facilitation skills
• Ability to collaborate with a cross functional team on solution design
• Proven experience analyzing business needs, eliciting and documenting effective user requirements for GxP system
• Knowledge on business process modelling and canonical
• Excellent verbal and written communication skills in English
• Experience working with global teams

Additional Requirements

• Regulatory domain knowledge (specifically Registration Information Management, IDMP, SPL) is a major plus

Pop Science are an innovative, personal and experienced recruitment and staffing consultancy. Our aim is to make science more popular by championing careers in clinical and scientific research, technology, engineering, maths and more. Whether you want a permanent job, a contract role or even a change in perspective with some volunteering, contact us and let us help you. We support working practises that promote happiness at work.

We're an experienced, skilled team with personality; we have a passion for science, and drive and enthusiasm to make a difference to you.

Find out more at Pop Science - Recruitment