Business Analyst

We have an immediate need for a Business Analyst/Business Process Specialist with experience of Pharma/Life Science for a long term contract in Basel.

We are looking for an experienced Business Process Expert (BPE) to lead requirements analysis of systems which re-define how The client operates in regulatory affairs. You will be working on global, cross divisional, strategic initiatives with the mandate to deliver GxP compliant solutions which will bring transformative change to the regulatory domain and will allow The client to realize a competitive advantage. 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.

The Business Process Expert has 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 fullfils the business requirements with a key focus on purpose, consistence and usability.

Good technical background in conjunction with proven business analysis techniques and well developed interpersonal skills are key success factor in this role.

PRINCIPAL RESPONSIBILITIES

- 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 that relevant stakeholders are involved in specification of new services and/or major upgrades to existing services
- Ensure the overall user experience is taken into account when designing and deploying new solutions and services
- 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 internal IT systems and documentation requirements, standards (including quality management and IT security)
- 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

MANDATORY SKILLS AND EXPERIENCE

- > 3-5+ years experience in SDLC and system validation
- > 3-5+ years in Drug Development domain
- > 5+ years in a business analyst/process role
- 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 analysing 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

WORKING LOCATION

- Basel