ITS Business Analyst
|Job Type|| Direct-hire/Full-time|
|Job ID Number||9920040101|
- He/She will be a member of the ITS GRA Regulatory Planning and Tracking team, acts as a key domain expertise to support GRA and ITS digital strategy and roadmap, identify and document key business/functional requirements, and contribute to ITS GRA project/service portfolio management.
- He/She will leverage digital technologies to support Global Regulatory Affairs (GRA) teams with focus on these business capabilities and their digital transformations: Regulatory Labeling/CMC, Regulatory Portfolio and Operational Planning, Reporting and Analytics, Ad Promo, Regulatory Requirements, and Regulatory Intelligence.
- He/She will provide ITS business analysis expertise to ITS GRA service and project teams in a highly regulated and dynamic environment, ensure traceability for GxP systems, and contribute to ensuring business continuity and compliance.
- The position will report to the Leader of ITS GRA Regulatory Planning and Tracking Service Line.
KNOWLEDGE AND SKILLS:
- Good understanding of information technology solutions, theory and principles and their applications to pharmaceutical/R&D/regulatory affairs areas.
- Good knowledge of business process and data in pharmaceutical industry. An experience on Pharma R&D and/or regulatory affairs environment is a plus.
- Good skills of business requirement gathering, analysis, and translation to technical specifications. An experience on business case development is a plus.
- Fluent in English, other language skills are a plus.
- Adaptability to a changing and highly dynamic work environment.
- Ability to build stakeholder relationships, contribute to and influence decision making, and resolve conflicts with stakeholders with tact and diplomacy.
- Work and communicate effectively as a team member and an individual contributor.
- Work autonomously with necessary supervision.
FORMAL EDUCATION AND EXPERIENCE REQUIRED:
- Bachelor's degree in computing, computer science, Pharmacy, Engineering or related scientific or technical discipline.
- 2-4 years IT experience in industry is required. Pharma experience is preferred.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Lead / Facilitate / contribute to business case developments and ensure that the business vision/strategy, process, data, value, potential ITS solution, and BUILD and RUN costs are accurately documented and properly analyzed. Facilitate a technical specification review and feedback sessions to update and finalize technical specifications that reflect business requirements. Serve as a liaison between business, ITS, and vendors during business case development, requirement gathering and analysis. Ensure traceability for GxP systems.
- Ensure the global end-to-end consistency of the ITS GRA services. Work as an adviser over the different phases of services life cycle: scope, analysis, design, functional validation and change management.
- Leverage on methods and tools to capture and analyze needs. Identify gaps with existing services. Propose and design evolution of services, processes and operating models compliant with company strategy. Make sure of the relevancy, practicality and usability of the services to meet service recipient satisfaction.
- Build up multiples services scenarios with multidimensional analysis in providing rankings, risks analysis, impacts on organization, finances, technologies, and way of working. Provide a clear description of expected results and benefices, architecture guidelines, recommendations according to context.
- When relevant, promote existing services and maximize usages and adoption of market standards. Contribute to assess service recipient workload, pre-requisites, and required conditions for a successful implementation, service adoption, and deployment steps.
KEY INTERNAL & EXTERNAL RELATIONSHIPS:
- ITS GRA service line leaders, service owners, project/program managers, and service operational team including external services (e.g., AMS).
- Other ITS service team, Business Partners, ITS quality, security, and procurement.
- GRA teams and business leaders.
- Other business teams such as IA, Clinical, GPV, Commercial, and Medical.
US Citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor any candidates at this time.